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AesRx Presents Phase 1/2a Trial Data of Anti-Sickling Agent Aes-103 at ASH

Study Shows Significant Reduction of Pain in Sickle Cell Patients in a Dose-Dependent and Time-Dependent Manner for Up to 24 Hours Following Single Dosing

NEWTON, MA, December 9, 2013AesRx, LLC announced that it, in collaboration with the National Institutes of Health, presented results of the Phase 1/2a clinical trial of its anti-sickling agent Aes-103 at the 2013 American Society of Hematology (ASH) annual meeting, with data showing a significant reduction of pain in sickle cell disease (SCD) patients following single dosing. Chronic and recurring pain are among the most common symptoms of the disease.

The recently completed Phase 1/2a study assessed the safety and tolerability of Aes-103 in stable SCD patients, as well as its pharmacokinetic and pharmacodynamic properties. In a double-blind, placebo-controlled, dose-escalation trial, 18 adult patients with stable SCD on or not on hydroxyurea treatment were given single oral doses of Aes-103 of 300, 1000, 2000 or 4000 mg, as well as 1000 mg q.i.d. for one day. Overall, Aes-103 was shown to be safe and well tolerated and no patients were discontinued due to adverse events.

For those patients (n=15 dose sessions) presenting with measurable pain at baseline (a score of 2 or more on the 0-10 Numerical Pain Rating Scale [NPRS]), pain was reduced in a dose-dependent and time-dependent manner in patients receiving Aes-103 compared to those receiving placebo. Reductions in pain became apparent starting about 1-2 hours after Aes-103 administration. Pain differences between Aes-103-treated and placebo-treated patients were in the range of 3-4 points on the NPRS scale. The differences between treatments peaked at 8 hours post-dose (p≤0.005) and persisted at 12 hours (p≤0.05) and 24 hours (p≤0.05) post-dose. Reductions in pain were highly correlated with the presence of Aes-103 in the red blood cell lysate (correlation coefficient = –0.917; p<0.0001). In contrast, patients with no pain shortly prior to dosing showed no change in pain levels over the next 24 hours in both the placebo and Aes-103 groups.

“We are extremely pleased with the outcome of our Phase 1/2a study,” commented Stephen R. Seiler, AesRx’s Chief Executive Officer. “The results clearly confirm Aes-103’s safety and support its promise as a disease-modifying treatment for sickle cell disease. We are particularly encouraged by the effect of Aes-103 on sickle cell pain, which presents an under-treated symptom of patients suffering from this disorder.”

Additional signals of potential anti-sickling activity were observed, including higher hemoglobin levels in patients receiving Aes-103 compared to placebo, as well as a reduction in LDH (a biomarker of red blood cell hemolysis). Red blood cell (RBC) sickling is a hallmark of sickle cell disease and, among other symptoms, results in more rapid RBC death in sickle cell patients than in those without the disease. Rapid RBC death in turn leads to anemia (lower levels of hemoglobin) and a rupturing of the RBC membrane, which releases LDH into the bloodstream.

Based on the positive results of AesRx’s Phase 1 and Phase 1/2a studies, a Phase 2 study has been initiated in the UK (see http://www.clinicaltrials.gov/ct2/show/NCT01987908/). It is planned as a randomized, double-blind controlled study of Aes-103 or placebo with daily dosing for 28 days in patients with sickle cell anemia.

The reported Phase 1/2a study in sickle-cell patients and the previous Phase 1 study in healthy subjects are part of a multi-institute, public-private translational research collaboration involving AesRx and two separate components of the National Institutes of Health (NIH): the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Advancing Translational Sciences (NCATS) through its Therapeutics for Rare and Neglected Diseases (TRND) program. Aes-103 is one of the first molecules to enter clinical development in the TRND program.

“TRND researchers have worked collaboratively with the AesRx team to provide the clinical and regulatory resources necessary to move Aes-103 through pre-clinical development and into human clinical trials,” said John McKew, Ph.D., acting director of NCATS Division of Pre-Clinical Innovation and director of TRND. “Through TRND, NCATS supports innovative methods and approaches to developing breakthrough treatments for patients who have urgent and unmet medical needs.”

In sickle cell disease, red blood cells deform into sickle shapes that can block small blood vessels and lead to serious conditions including chronic pain and acute painful crisis. Aes-103 directly inhibits polymerization (sickling) by stabilizing sickle hemoglobin in the R state. To AesRx’s knowledge, Aes-103 is the only direct anti-sickling agent in or near clinical development. The U.S. Food and Drug Administration (FDA), has designated Aes-103 as an orphan drug for the treatment of sickle cell disease.

Note: References to the National Institutes of Health, its programs or its staff, should not be viewed as an endorsement or implied endorsement of AesRx, its products or services. Additional information about sickle cell disease is available at: 

Sickle Cell Anemia, http://www.nhlbi.nih.gov/health/dci/Diseases/Sca/SCA_WhatIs.html

Sickle Cell Disease, http://www.cdc.gov/NCBDDD/sicklecell/index.html

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by stabilizing sickle hemoglobin in the high oxygen affinity R-State. Sickle hemoglobin in the R-State cannot polymerize (sickle). In addition, data recently developed at the NIH indicates Aes-103 can stabilize red blood cells against physical shear stress. Vascular inflammation is a common feature of SCD. It exposes the sickle red blood cells to shear stress which in turn leads to cell death. Aes-103 may help prevent this.

AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis. 

For more information about AesRx and Aes-103, see AesRx.com.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.



AesRx Anti-Sickling Drug Aes-103 Begins Phase 2 Trial

NEWTON, MA, September 3, 2013—AesRx, LLC, announced it has received regulatory and ethics committee approval for a Phase 2 clinical trial of its novel Aes-103 anti-sickling agent in patients with sickle cell disease (SCD). The Company plans for patient enrollment to start this month.

This is the first Phase 2 trial of Aes-103 for SCD and as such marks an important milestone in the drug’s development. This double-blind, placebo controlled study will evaluate the safety and pharmacokinetics of 28-day dosing of Aes-103. In addition, the impact of Aes-103 on several sickle cell clinical endpoints will be evaluated. The trial is part of an ongoing collaboration between AesRx and the National Center for Advancing Translational Sciences (NCATS) through its Therapeutics for Rare and Neglected Diseases (TRND) program.  NCATS is one of the National Institutes of Health (NIH).

 “Aes-103 is now in Phase 2. This is a major step forward for the program,” commented Stephen R. Seiler, AesRx’s Chief Executive Officer. “In 2012 we completed a Phase 1 trial in healthy volunteers and recently successfully completed a Phase 1/2a trial in patients with stable sickle cell disease. Aes-103 doses from 300mg to 4000mg per day were observed to be safe and well tolerated in both healthy volunteers and sickle cell patients. We have reported the results of the Phase 1 trial (American Society of Hematology, Dec. 2012) and anticipate presenting the results of the Phase 1/2a trial at a major scientific conference later this year. The current Phase 2 trial will allow us for the first time to begin examining not only safety over a longer dosing period, but also the potential impact of Aes-103 on some of the important clinical symptoms associated with SCD.”

“TRND researchers have worked collaboratively with AesRx to provide preclinical drug development expertise and clinical and regulatory resources necessary to move Aes-103 into human clinical trials,” said John McKew, Ph.D., acting director of NCATS Division of Preclinical Innovation and director of TRND. “Through TRND, NCATS supports innovative methods and collaborative approaches to accelerate the discovery process while developing promising treatments for the patients who need them.”
Aes-103 has been designated as an orphan drug by the U.S. Food and Drug Administration. It is a first-in-class, orally bioavailable small molecule for the treatment of SCD. AesRx believes it is the only drug currently in human trials that directly blocks cell sickling.

Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 100,000 people in the United States are afflicted with sickle cell disease.
Note: References to the National Institutes of Health, its programs or its staff, should not be viewed as an endorsement or implied endorsement of AesRx, its products or services. Additional information about sickle cell disease is available at: 
Sickle Cell Anemia, http://www.nhlbi.nih.gov/health/dci/Diseases/Sca/SCA_WhatIs.html
Sickle Cell Disease, http://www.cdc.gov/NCBDDD/sicklecell/index.html

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by stabilizing sickle hemoglobin in the high oxygen affinity R-State. Sickle hemoglobin in the R-State cannot polymerize (sickle). In addition, data recently developed at the NIH indicates Aes-103 can stabilize red blood cells against shear stress. Vascular inflammation is a common feature of SCD. It exposes the sickle red blood cells to shear stress which in turn leads to cell death. Aes-103 may help prevent this. AesRx is currently developing Aes-103 in collaboration with the National Institutes of Health.

AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis. 

For more information about AesRx and Aes-103, see AesRx.com.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx to Present Phase 1 Data on Anti-Sickling Agent Aes-103 at ASH

NEWTON, MA, November 27, 2012—AesRx announced it will present data from the recently completed Phase 1 study of its anti-sickling agent Aes-103 at the 2012 American Society of Hematology (ASH) meeting in Atlanta. The data will be presented in a poster session on December 10.

Data shows the drug is safe and well-tolerated. It also shows Aes-103 is biologically active in humans in a manner consistent with its proposed mechanism of action in sickle cell disease.

The first-in-human, double-blind, placebo-controlled clinical trial was conducted in collaboration with the National Institutes of Health (NIH). The trial examined the effects of single doses of Aes-103 at 300 mg, 1000 mg, 2000 mg and 4000 mg or placebo in 20 healthy normal volunteers of African-American descent. Endpoints were focused on safety, pharmacokinetics and pharmacodynamic changes.

The safety measures showed no clinically significant adverse effects on vital signs, ECGs, clinical laboratory tests, physical exams or adverse events. All adverse events were mild and transient. The pharmacokinetics of Aes-103 showed 5-10 fold higher drug concentrations in red blood cells, which is the site of action of Aes-103 on hemoglobin, compared to drug concentrations in plasma. Aes-103 was rapidly absorbed and the amount of Aes-103 in plasma and red blood cells was largely dose proportional.

Pharmacodynamic effects were also examined to determine the ability of Aes-103 to increase the oxygen affinity of the hemoglobin of the healthy volunteers. In a hypoxia challenge test, the subjects inhaled low levels of oxygen (12%) while their blood oxygen levels (SpO2%) were monitored. Aes-103 in 1000-4000 mg doses reduced the hypoxia-related drop in subjects’ SpO2% compared to placebo and the 300 mg dose.

“We are very pleased with the results of our Phase 1 study,” commented Stephen R. Seiler, AesRx’s Chief Executive Officer. “In sickle cell patients, increasing the oxygen affinity of hemoglobin is known to prevent red blood cell sickling. The ability of Aes-103 to provide protection in a hypoxia challenge of healthy volunteers indicates biological activity in humans in a manner consistent with Aes-103’s proposed mechanism of action in sickle cell disease.”

Based on these positive results, a second trial of similar design enrolling patients with sickle cell disease has been initiated at the NIH Clinical Center in Bethesda, MD and is currently ongoing (see http://www.clinicaltrials.gov/ct2/show/NCT01597401?term=aes-103&rank=1).

The reported Phase 1 study and the ongoing Phase 1/2a study in sickle cell patients are part of a multi-institute, public-private translational research collaboration involving AesRx and two separate NIH components—the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Advancing Translational Sciences (NCATS) through its Therapeutics for Rare and Neglected Diseases (TRND) program.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is developing Aes-103 in collaboration with the National Institutes of Health. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

For more information about AesRx and Aes-103, see AesRx.com.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Anti-Sickling Drug Aes-103 Enters Phase 1/2a Clinical Trial at NIH

NEWTON, MA, MAY 14, 2012—AesRx, LLC, announced it has begun a Phase 1/2a clinical trial of its novel Aes-103 anti-sickling agent in patients with sickle cell disease (SCD). This trial, which marks an important milestone in the development of Aes-103 as a treatment for sickle cell disease, is part of an ongoing collaboration between AesRx and the National Institutes of Health (NIH).

The trial is being conducted at the NIH Clinical Center in Bethesda, MD. The AesRx/NIH collaboration involves two separate NIH components—the National Heart, Lung, and Blood Institute (NHLBI) and the Therapeutics for Rare and Neglected Diseases (TRND) program. TRND is part of the National Center for Advancing Translational Sciences (NCATS). TRND and AesRx worked together to complete in less than a year all pre-clinical development needed for the FDA to allow Aes-103 as an investigational new drug and proceed with human clinical trials.

“The commencement of clinical trials in sickle cell patients marks a major step forward for Aes-103,” commented Stephen R. Seiler, AesRx’s Chief Executive Officer. “If successful, the Aes-103 program will represent a breakthrough in the treatment of sickle cell disease. While sickle cell patients currently have several treatment options, the lack of therapies that can prevent cell sickling represents a major unmet medical need.”

Aes-103 has been designated as an orphan drug by the U.S. Food and Drug Administration. It is a first-in-class, orally bioavailable small molecule for the treatment of SCD. AesRx believes it is the only drug currently in human trials that directly blocks cell sickling. While red blood cells are normally round, people who have sickle cell disease produce crescent-shaped cells, which can cause blood flow problems. The present trial will examine the safety and tolerability of Aes-103 in stable sickle cell disease patients as well as the drug’s pharmacokinetic and pharmacodynamic properties.

“This study represents a crucial effort to translate basic science findings into a new treatment for sickle cell disease,” said Gregory Kato, M.D., a hematologist with the NHLBI and principal investigator of the Aes-103 study.

“The TRND program has made significant contributions to the development of Aes-103 as a potential treatment for those suffering from sickle cell disease,” said Christopher P. Austin, M.D., director of the Division of Pre-Clinical Innovation at NCATS. “This project epitomizes both the urgent and neglected medical needs, and the innovative scientific and collaborative approaches to solving them, that are TRND’s mission.”

For more information on this trial, go to: http://www.clinicaltrials.gov/ct2/show/NCT01597401

Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 75,000 people in the United States, and 13 million individuals worldwide, are afflicted with sickle cell disease.

Note: References to the National Institutes of Health, its programs or its staff, should not be viewed as an endorsement or implied endorsement of AesRx, its products or services. Additional information about sickle cell disease is available at:
Sickle Cell Anemia, http://www.nhlbi.nih.gov/health/dci/Diseases/Sca/SCA_WhatIs.html
Sickle Cell Disease, http://www.cdc.gov/NCBDDD/sicklecell/index.html

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is developing Aes-103 in collaboration with the National Institutes of Health. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Begins Clinical Trial of Aes-103 For Sickle Cell Disease

NEWTON, MA, December 6, 2011—
AesRx, LLC announced today it has commenced a clinical trial of Aes-103, the company’s novel anti-sickling agent. Aes-103, designated as an orphan drug by the U.S. Food and Drug Administration, is a first-in-class, orally bioavailable small molecule therapeutic under investigation for the treatment of sickle cell disease (SCD). This trial will examine the safety and tolerability of Aes-103 in healthy volunteers as well as the drug’s pharmacokinetic and pharmacodynamic properties.

Aes-103’s proposed mechanism of action is targeted to reduce cell sickling. AesRx believes it is the only anti-sickling drug currently in human trials. The present trial is part of an ongoing collaboration between AesRx and two separate components of the National Institutes of Health (NIH)—the National Heart, Lung, and Blood Institute (NHLBI) and the Therapeutics for Rare and Neglected Diseases (TRND) program. The collaboration is planned to develop Aes-103 through completion of initial proof of principle trials.

“We are obviously delighted with today’s announcement,” commented Stephen R Seiler, AesRx’s Chief Executive Officer. “Aes-103 represents an attractive development opportunity in our view because the proposed mechanism of action has been widely studied and X-ray crystallography indicates it binds a target of interest on sickle hemoglobin. This trial marks an important milestone in the development of Aes-103. We are extremely gratified to have had support from the NIH to advance the research on this compound.” 

“We are very excited to see Aes-103 being studied in a clinical trial,” added Lanetta B. Jordan, M.D., M.P.H., M.S.P.H., Chief Medical Officer of the Sickle Cell Disease Association of American and a member of AesRx’s Strategic Advisory Board. “If successful, it would represent a breakthrough in the treatment of sickle cell disease. Although SCD was first discovered over 100 years ago, there has never been a drug developed specifically to treat SCD and there is currently no known drug that directly blocks the sickling which causes the morbidity and mortality associated with the disease. We look forward to the further development of this important therapeutic.” 

About NIH, NHLBI, and TRND

The National Institutes of Health (NIH) is the nation's medical research agency. It includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

The NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders.

TRND is overseen by the NIH Center for Translational Therapeutics (NCTT), which is administered by the National Human Genome Research Institute, another component of the NIH. NCTT’s Bridging Interventional Development Gaps (BrIDGs) program also contributed research material to develop Aes-103.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is developing Aes-103 in collaboration with the National Institutes of Health. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Awarded Mass Life Science Center Accelerator Loan

NEWTON, MA, March 24, 2011AesRx, a company developing a potential treatment for sickle cell disease, announced today it has been awarded a $750,000 Accelerator Program loan from the Massachusetts Life Science Center (the “Center”).

“We are delighted to have won the opportunity to participate in this prestigious program,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “It will make a significant contribution to allowing us to take Aes-103 into sickle cell patients with the objective of achieving proof of concept. We very much appreciate the vote of confidence from the Center.”

The Center is a quasi-public agency tasked with implementing the state’s 10-year, $1 billion Life Sciences Initiative. The Accelerator Program provides loans of up to $750,000 to early-stage companies engaged in life sciences research and development with a high potential for technology commercialization, rapid growth, and downstream private equity financing.

The Center’s selection process included a rigorous double-blind peer review, an evaluation by the Center’s Scientific Advisory Board, and a screening by the Center’s Investment Sub-Committee of the Board of Directors. Final awards were determined by the Center’s Board of Directors.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. AesRx is developing Aes-103 in collaboration with the NIH which will take the program through pre-clinical development and initial clinical trials. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2011. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.



AesRx Announces Collaboration With NIH to Develop Aes-103 for Sickle Cell Disease

NEWTON, MA, November 17, 2010AesRx, LLC, announced today that it has entered into a collaboration with the National Institutes of Health (NIH) to take AesRx’s investigational sickle cell therapeutic, Aes-103, through pre-clinical development and initial clinical trials, including two trials in sickle cell patients. Several NIH components will contribute to the research, including the NIH Therapeutics for Rare and Neglected Diseases (TRND) program, the NIH Clinical Center, and the National Heart, Lung, and Blood Institute (NHLBI).

The U.S. Food and Drug Administration (FDA), has designated Aes-103 as an orphan drug for the treatment of sickle cell disease. Aes-103 is intended to reduce blood cell sickling, a condition in which the normal doughnut-round shape of a red blood cell is distorted in to a sickle-shape because of an inherited defect in the oxygen-carrying protein hemoglobin.

Aes-103 is believed to be the only clinical-stage therapeutic that directly targets cell sickling.

Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals worldwide are afflicted with sickle cell disease.

TRND and AesRx are currently collaborating to complete all pre-clinical development activities needed for the FDA to review an investigational new drug (IND) application for Aes-103. Once the IND goes into effect, clinical studies in healthy volunteers and sickle cell patients will be conducted next year by the intramural research program of the NHLBI. Researchers will conduct the trials in the NIH Clinical Center on the Bethesda campus. The Aes-103 development program has previously benefitted from two NIH grants, a Rapid Access to Interventional Development (RAID) grant and a Small Business Innovation Research (SBIR) grant.

“We are delighted to have the opportunity to work with the NIH,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “Aes-103 represents an attractive development opportunity in our view because its mechanism of action has been widely studied and X-ray crystallography indicates that it binds a target of interest on sickle hemoglobin. Aes-103 could be a breakthrough in the treatment of sickle cell disease. We are pleased that the NIH has chosen to collaborate with us to move it into the clinic.”

“Seeing Aes-103 reach sickle cell patients would be very exciting,” added Lanetta B. Jordan, M.D., M.P.H., M.S.P.H., chief medical officer of the Sickle Cell Disease Association of America and a member of AesRx’s Strategic Advisory Board. “A therapy such as Aes-103 could provide an important new treatment option for patients afflicted with this disease.”

Aes-103 is one of the first molecules to enter development in the TRND program. Congress funded TRND (trnd.nih.gov) to speed the development of new medications that might otherwise be ignored by industry because they are too early in the development process or would not be sufficiently profitable. TRND provides drug development expertise and resources required to produce compounds that can be tested in people, including medicinal chemistry needed to turn the compound into a substance that can be used in the body and pre-clinical safety testing.

“TRND collaborates with researchers and companies to turn promising molecules into potential new drugs for rare and neglected diseases,” said NHGRI’s Christopher P. Austin, M.D., director of the NIH TRND program. “But this is the most difficult part of drug development, and the failure rate is high for any molecule that we are trying to turn into a medicine. It’s important to remember that the ultimate outcome for any compound is hard to predict.”

If the pre-clinical development and safety testing goes well enough for the FDA to issue an IND, tests of the sickle disease treatment will move to the NIH Clinical Center for trials with human volunteers.

“Patients with sickle cell disease suffer a great deal from pain and organ damage, and our research group is committed to finding effective new treatments. Based on our extensive review of the data, we believe there is value in exploring Aes-103 as a potential treatment for sickle cell patients,” said Gregory Kato, M.D., of the cardiovascular and pulmonary branch of the NHLBI’s Division of Intramural Research and the principal investigator for the planned clinical trials.

Note: References to the National Institutes of Health, its programs or its staff, should not be viewed as an endorsement or implied endorsement of AesRx, its products or services. Additional information about sickle cell disease is available at:
Sickle Cell Anemia, http://www.nhlbi.nih.gov/health/dci/Diseases/Sca/SCA_WhatIs.html
Sickle Cell Disease, http://www.cdc.gov/NCBDDD/sicklecell/index.html

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2011. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. Planned clinical trials may be subject to FDA and other regulatory review prior to commencement. These statements are subject to numerous risks and uncertainties.

 


Professor Henry Louis Gates, Jr., Joins AesRx
Strategic Advisory Board

Newton, MA, June 1, 2010—AesRx, LLC, a biopharmaceutical company working to develop a treatment for sickle cell disease, announced today that Henry Louis Gates, Jr., has become a member of the company’s Strategic Advisory Board. Professor Gates is the Alphonse Fletcher University Professor at Harvard University and the Director of the W. E. B. Du Bois Institute for African and African American Studies.

“We are privileged to welcome Professor Gates as a strategic advisor,” said Stephen R. Seiler, Chief Executive Officer of AesRx. “He understands the urgency of fighting sickle cell disease around the world and his insights will greatly help us in our quest to develop an effective treatment.”

“Sickle cell disease was the first disease discovered to be of a genetic origin,” commented Professor Gates.  “Yet in the six decades since that discovery, not a single drug has been developed specifically for its treatment.  While the burden of sickle cell disease in the US falls heavily on African Americans, it can also afflict Hispanic Americans as well as individuals of Portuguese, Spanish, Corsican, Sardinian, Sicilian, Greek and Turkish origin among others. Over 13 million individuals world-wide are affected.  I’m pleased to join AesRx in its groundbreaking efforts to develop a treatment for sickle cell.”

Henry Louis Gates, Jr., is the Alphonse Fletcher University Professor and the Director of the W.E.B. Du Bois Institute for African and African American Research at Harvard University. An influential scholar in the field of African American Studies, he is the author of 12 books and has produced and hosted 10 documentaries, including the acclaimed PBS films “Faces of America” and “African American Lives 1 and 2.” His next film, “The Black Americas,” will air on PBS in February 2011. Professor Gates is co-editor, with Professor Evelyn Brooks Higginbotham, of the African American National Biography (an eight-volume biographical dictionary published by Oxford University Press in 2008), and his recent work has been instrumental in popularizing African American genealogical research and DNA testing. His book, In Search of Our Roots: How 19 Extraordinary African Americans Reclaimed Their Past, won an NAACP Image Award in 2010. He is the recipient of 50 honorary degrees and many awards, including the MacArthur Foundation “genius grant” and the National Humanities Medal, awarded by President Bill Clinton. He was named to Time magazine’s “25 Most Influential Americans” list in 1997, and to Ebony magazine’s “100 Most Influential Black Americans” list in 2005 and its “Power 150” list in 2009. Professor Gates is the first African American to have his genome fully sequenced, and is also half of the first father-and-son pair to have their genomes fully sequenced.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx CEO Selected as Panelist for Georgetown Biotechnology Event

NEWTON, MA, May 24, 2010—AesRx, LLC, announced that Stephen R. Seiler, the company’s founder and Chief Executive Officer, has been selected as a panelist for the Georgetown University event, “Biotechnology Forging the Way to Personalized Medicine: Science, Policy, and Ethical Issues,” to take place June 23, 2010.

Other panelists include: Howard J. Federoff. MD, Ph.D., Executive Dean of the Georgetown University School of Medicine; Lawrence O. Gostin, Director of the O'Neill Institute for National & Global Health Law; and Maggie Little, Director of the Kennedy Institute of Ethics.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Advisory Board Member Lanetta Jordan, MD, Appointed to National Heart, Lung, and Blood Advisory Council

NEWTON, MA, March 25, 2010—AesRx, LLC, announced today that Lanetta Jordan MD, a member of its Strategic Advisory Board, has been appointed to The National Heart, Lung, and Blood Advisory Council. The Council advises the Secretary of the Department of Health and Human Services, the Assistant Secretary for Health, the Director of the National Institutes of Health, and the Director of the National Heart, Lung, and Blood Institute on matters relating to the cause, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases.

“Dr. Jordan’s appointment to the Council is well deserved recognition of her work and leading position as an advocate for patients with blood disease,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “Moreover, as a physician she is dedicated to improving the quality of life, health, programs and services for individuals with sickle cell disease and other hemoglobinopathies.”

In addition to her roles on AesRx’s Strategic Advisory Board and The National Heart, Lung, and Blood Advisory Council, Dr. Jordan is Chief Medical Officer of the Sickle Cell Disease Association of America. She is also Director of the Department of Sickle Cell Services at Memorial Healthcare System, where she heads activities which focus on adolescent and adult acute pain care, comprehensive follow-up care, research and grants, community outreach education, genetic counseling and screening, and an adolescent transition program. In 2004, Dr. Jordan spearheaded the successful Joint Commission Disease Specific Certification of Distinction for Sickle Cell Disease at Memorial Regional Hospital. She serves as Chair of the US Sickle Cell Disease Surveillance Workgroup and the Sickle Cell Disease United Voice Group both of which were created out of the America Society of Pediatric Hematology, Oncology’s Sickle Cell Summit. Dr. Jordan was appointed to the state of Florida’s Health Care Transition Task Force for Youth and Young Adults with Disabilities. She is also a teacher and co-author of various articles, abstracts and policy briefs.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of treatments for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical or clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Appoints Lanetta Jordan, Chief Medical Officer of the Sickle Cell Disease Association of America, to the Company's Strategic Advisory Board

NEWTON, MA, February 25, 2010—AesRx, LLC, announced today it has appointed Lanetta Jordan, MD, the Chief Medical Officer of the Sickle Cell Disease Association of America (SCDAA), to its Strategic Advisory Board. Dr. Jordan is also Director of the Department of Sickle Cell Services at Memorial Healthcare System in Hollywood, Florida, a position she has held since founding that department in 2004.

“We are delighted to add Dr. Jordan to our Strategic Advisory Board,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “She has demonstrated an extraordinary commitment to the treatment of sickle cell patients both in her work on behalf of the SCDAA and in her position as head of Memorial Healthcare System’s Department of Sickle Cell Services. Dr. Jordan’s passion and drive will be of great assistance to AesRx as we move Aes-103 into the clinic and push forward with this important development program for a unique sickle cell therapeutic.”

“I’m pleased to be able to join AesRx in this effort,” added Dr. Jordan. “There has been too little progress in finding new therapies for sickle cell patients. If successful, Aes-103 could create a new paradigm in the treatment of this devastating disease.”

Dr. Jordan was appointed the Chief Medical Officer of the Sickle Cell Disease Association of America in September 2008. As Director of the Department of Sickle Cell Services at Memorial Healthcare System, she heads activities which focus on adolescent and adult acute pain care, comprehensive follow-up care, research and grants, community outreach education, genetic counseling and screening, and an adolescent transition program. In 2004, Dr. Jordan spearheaded the successful Joint Commission Disease Specific Certification of Distinction for Sickle Cell Disease at Memorial Regional Hospital. She serves as Chair of the US Sickle Cell Disease Surveillance Workgroup and the Sickle Cell Disease United Voice Group both of which were created out of the America Society of Pediatric Hematology, Oncology’s Sickle Cell Summit. Dr. Jordan was appointed to the state of Florida’s Health Care Transition Task Force for Youth and Young Adults with Disabilities. She is also a teacher and co-author of various articles, abstracts and policy briefs.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of products for two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx and Its Sickle Cell Program Featured in Xconomy

NEWTON, MASSACHUSETTS, January 5, 2010—AesRx announced that the Company and Aes-103, its lead development program targeted to the treatment of sickle cell disease, have been featured in today’s edition of Xconomy (http://www.xconomy.com/boston/2010/01/05/former-idera-pharma-ceo-at-helm-of-aesrx-new-startup-with-sickle-cell-drug/). Xconomy is dedicated to providing business and technology leaders with timely, insightful, close-to-the-scene information about the local personalities, companies, and technological trends that best exemplify today’s high-tech economy.

“We are pleased to be featured in Xconomy,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “Aes-103 is the only therapeutic targeted to stop cell sickling that is in or nearing clinical trials. As such, Aes-103 may be a significant new treatment for this devastating disease. We are delighted for the recognition of this important drug candidate and the work AesRx is doing.”

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of two orphan diseases. The Company’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010. AesRx’s second development program, Aes-210, is targeted to treat certain inflammatory diseases of the lower intestine, including distal ulcerative colitis, pouchitis and radiation induced proctitis.


This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Acquires Rights to Second Orphan Drug Program
Potential Treatment for Pouchitis in Phase 2

NEWTON, MASSACHUSETTS, September 7, 2009—AesRx announced today that it has acquired the development rights to a second orphan drug. The program, which will be designated Aes-210, has been in-licensed from Children’s Hospital Boston. Aes-210 is currently in a Phase 2 trial evaluating it as a treatment for an orphan disease known as pouchitis. AesRx believes Aes-210 will also prove useful for the treatment of other inflammatory diseases of the lower intestine, such as distal ulcerative colitis and radiation induced proctitis.

“We are delighted to have added a second product to AesRx’s development portfolio,” said Stephen R. Seiler, AesRx’s CEO. “While our sickle cell program remains the primary focus of our company, Aes-210 will provide an excellent complement.”

“Aes-210 is currently being evaluated for the treatment of pouchitis in a Phase 2 trial known as the CAPTURE Study,” Mr. Seiler added. “It has already been designated an Orphan Drug and the first portion of the CAPTURE Study was financed by a grant from the FDA’s Orphan Drug Products group. Data from the first cohort of patients enrolled has been extremely promising. Even with a modest sample size (n=11) there was almost a 2-to-1 ratio in the number of patients receiving Aes-210 who experienced a reduction of 3 points or more in their score on the study’s primary endpoint, the Pouchitis Disease Activity Index (PDAI), when compared to the placebo group. Perhaps just as important, increases in quality of life as measured by the Rating Form for Inflammatory Bowel Disease Patient Concerns (RFIPC) reached levels that were close to being statistically significant (p<0.07).”

“Aes-210 has the potential to help a significant percentage of patients struggling with chronic pouchitis,” commented Dr. Paul Rufo, M.D., M.M.Sc., Assistant in Medicine in Gastroenterology, Children’s Hospital Boston and co-inventor of the technology. “We are pleased to be working with AesRx to move this very promising program forward.”

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of novel therapeutics for two orphan diseases. In addition to Aes-210, AesRx’s lead program (Aes-103) is targeted to the treatment of sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


Second NIH Grant Enables Production of Aes-103 for Clinical Trials

NEWTON, MASSACHUSETTS, June 4, 2009—AesRx announced today that funds obtained from the National Institutes of Health (NIH) under a Rapid Access to Interventional Development (RAID) grant have enabled the manufacture of Aes-103 under GMP conditions to support its Phase 1 clinical program. This is the second NIH grant for Aes-103. The NIH has also awarded a Small Business Innovation Research (SBIR) grant to support the pre-clinical development of Aes-103.

“This is clearly good news for Aes-103 as it provides non-dilutive funding for a key element of our development program,” commented Warren C. Stern, Ph.D., AesRx’s Senior Vice President of Drug Development. “In addition, we are aware that grant funding in this particular study section of the NIH is extremely competitive. Only projects in or near the top decile qualify. The fact that Aes-103 has benefited from two separate NIH grants reflects very positively, in our view, on the quality and clinical importance of the science behind it.”

Based on its current development plan, AesRx believes that the quantity of Aes-103 manufactured under the RAID grant will be sufficient to provide drug for its entire Phase 1 program. AesRx plans to commence human clinical trials for Aes-103 in 2010.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of a new treatment for sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. AesRx’s lead development program, Aes-103 works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Director Colin Hill Named Master of Innovation by Black Enterprise Magazine

NEWTON, MASSACHUSETTS, March 15, 2009 — AesRx, LLC, announced today that one of the members of its Board of Directors, Colin Hill, has been named a Master of Innovation in an article in the March issue of Black Enterprise magazine.

The article highlights African-Americans who are technology leaders in a wide range of fields from academia and industry to NASA. Mr. Hill was previously picked by Black Enterprise as a “Rising Star” and in 2004 he was named to MIT Technology Review's TR100 list of the top innovators in the world under the age of 35.

“We are delighted at the well earned recognition Colin has received,” said Stephen R. Seiler, AesRx’s founder and CEO. “As the article points out, Colin and innovators like him ‘are reshaping the world.’ We are pleased to have his guidance and insight as we move forward with development of Aes-103 and seek to reshape the future of treatment for individuals with sickle cell disease.”

Mr. Hill is Chairman, Chief Executive Officer and President of Gene Network Sciences a company which he co-founded in 2000. Gene Network Sciences is built on a collaborative team of computational physicists, mathematicians, chemists, molecular biologists, bioinformaticians, and software engineers who together work to reveal the molecular basis of health and disease through examination of the critical biological relationships among genes and proteins and how these complex relationships impact disease progression, drug efficacy and drug toxicity. He is also Chairman of the Board of Fina Technologies, a spin-off of Gene Network Sciences that applies next-generation artificial intelligence technology to real-time financial trading.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of a new treatment for sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. AesRx’s lead development program, Aes-103, works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Adds Mary K. Pendergast to Board of Directors

NEWTON, MASSACHUSETTS, February 12, 2009AesRx, LLC, a biopharmaceutical company developing Aes-103 as a potential drug treatment for sickle cell disease, announced today that it has appointed Mary K. Pendergast to its Board of Directors.

“Mary is an important addition to AesRx’s team,” said Stephen R. Seiler, AesRx’s Chief Executive Officer. “She brings many years of experience in the regulatory aspects of drug development first at the FDA and more recently in private industry. As we transition Aes-103 into clinical trials, regulatory issues will obviously become increasingly important. We delighted that she will be joining our Board.”

Ms. Pendergast is President of Pendergast Consulting, a firm which provides legal and regulatory consulting services to pharmaceutical and biotechnology companies and other entities and which Ms. Pendergast founded in 2003. Prior thereto, Ms. Pendergast served as Executive Vice President, Government Affairs for Elan Corporation, plc, from 1998 to 2003. Ms. Pendergast was Deputy Commissioner and Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services from 1990 to 1998, and Associate Chief Counsel for Enforcement at FDA from 1979-1990.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of a new treatment for sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. AesRx’s lead development program, Aes-103, works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.


AesRx Announces Appointment of Maggie LeFlore and Colin Hill to Board of Directors

NEWTON, MASSACHUSETTS, January 21, 2009—AesRx, LLC, a biopharmaceutical company developing Aes-103 as a potential drug treatment for sickle cell disease, announced today that it has appointed Maggie Flanagan LeFlore, Ph.D., and Colin Hill to its Board of Directors.

“We are pleased to have Maggie and Colin join us,” commented Stephen R. Seiler, AesRx’s founder and CEO. “Maggie has extensive venture capital experience and business development experience. She also brings a large pharma perspective on drug development and licensing. Colin is a successful biotech entrepreneur having founded Gene Network Sciences, which is doing cutting edge work in the application of computational biology and molecular analysis to drug development Their experience and judgment will add significantly to our company as we move forward with the development of Aes-103 for sickle cell disease.”

Dr. LeFlore is a Managing Director of MedImmune Ventures, Inc. (a subsidiary of AstraZeneca plc.) a position she has held since 2007. Prior to joining MedImmune Ventures, Dr. LeFlore worked in business development for AstraZeneca from 2001-2007, including roles as Head of R&D Ventures as well as Global Alliance Director for Global Sciences and Information. From 2005-2007, while on secondment from AstraZeneca, she was a member of the Healthcare and Life Sciences venture capital investment team of Advent International. In addition, Dr. LeFlore has held business development and scientific management roles at Hybridon, Inc., Oncogene Science, Inc. and Merrell Dow Pharmaceuticals.

Mr. Hill is Chairman, Chief Executive Officer and President of Gene Network Sciences, a company he co-founded in 2000. Gene Network Sciences is built on a collaborative team of computational physicists, mathematicians, chemists, molecular biologists, bioinformaticians, and software engineers who together work to reveal the molecular basis of health and disease through examination of the critical biological relationships among genes and proteins and how these complex relationships impact disease progression, drug efficacy and drug toxicity. He is also Chairman of the Board of Fina Technologies, a spin-off of Gene Network Sciences that applies next-generation artificial intelligence technology to real-time financial trading.

About AesRx

AesRx is a biopharmaceutical company dedicated to the development of a new treatment for sickle cell disease. Sickle cell disease is a recessive disorder of the hemoglobin which can lead to a wide range of serious, sometimes life-threatening, conditions including: chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, and cumulative damage to tissues and organs. More than 13 million individuals world-wide are afflicted with sickle cell disease. AesRx’s lead development program, Aes-103, works by increasing the affinity of sickle hemoglobin for oxygen. Because only red blood cells with no bound oxygen will sickle, increasing the ability of the sickle red blood cells to bind oxygen reduces the number of cells that can sickle. AesRx is completing the pre-clinical development program for Aes-103 and expects to begin human clinical trials in 2010.

This press release contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio, pipeline and clinical programs (collectively the “Products”) of AesRx LLC (the “Company”), the market opportunities for the Products, the potential effectiveness of the Products based on the interpretation of past and/or planned pre-clinical data and the Company’s goals and objectives. These statements are subject to numerous risks and uncertainties.