PipelineReview.com - Biotech News & Online Store - Affymax begins phase 2 clinical trial of Hematide™ in patients with anemia associated with cancer and cancer chemotherapy

Affymax begins phase 2 clinical trial of Hematide™ in patients with anemia associated with cancer and cancer chemotherapy

30 Jan 2006

Affymax, Inc., a clinical-stage pharmaceutical company, today announced that it has initiated a Phase 2 clinical trial of Hematide(TM) to treat anemia in cancer patients.

Palo Alto, Ca. US | Jan 30, 2006| Affymax, Inc., a clinical-stage pharmaceutical company, today announced that it has initiated a

Phase 2 clinical trial of Hematide™ to treat anemia in cancer patients. Hematide, the Company's first product candidate to enter the clinic, is a novel peptide-based drug designed to stimulate the production of red blood cells. The open-label, multi-center, dose-escalation trial is being conducted at multiple clinical sites in several European countries and will evaluate the safety, pharmacodynamics, and pharmacokinetics of subcutaneously administered Hematide in cancer patients receiving chemotherapy.

"Approximately two-thirds of all cancer patients suffer from anemia, a serious complication of their cancer or cancer treatment that significantly impacts their ability to function normally and to withstand the side effects of cancer therapy," said Robert B. Naso, Ph.D., executive vice president, research and development, at Affymax. "New treatment options, such as innovative, long-acting erythropoiesis-stimulating agents, are needed to treat cancer-related and chemotherapy-induced anemia."

Hematide has been evaluated in a Phase 1 trial in healthy volunteers and in a Phase 2 trial in patients with anemia due to chronic kidney disease (CKD) who are not on dialysis and have not previously been treated with erythropoietin. To date, final results from the Phase 1 study and interim results from the first cohort of patients in the Phase 2 CKD trial have demonstrated proof-of-concept erythropoietic activity. After 28 days of follow-up of CKD patients, results showed that a single IV dose of Hematide was well tolerated and resulted in a clinically significant increase in hemoglobin from baseline, which was sustained for more than one month. Six of seven patients (86 percent) who received Hematide had a hemoglobin increase >1 g/dL. Changes in other pharmacodynamic parameters (e.g., increased hematocrit and red blood cells) were consistent with stimulation of erythropoiesis.

"The initiation of this new Phase 2 study of Hematide in cancer patients on chemotherapy is a significant milestone in our clinical development plan, which is evaluating Hematide in multiple Phase 2 trials in patient populations with significant unmet medical needs," said Arlene M. Morris, Affymax's president and chief executive officer. "We believe that Hematide represents a breakthrough erythropoiesis-stimulating agent that, if proven safe and effective in clinical trials, may improve the management of anemia and offer an important new treatment option for patients with anemia due to CKD or cancer."

In addition to the Phase 2 trial in cancer patients, Hematide is also currently being studied in a Phase 2b open-label, repeat dose, dose-finding study in the U.S. in hemodialysis patients with end-stage renal disease, and separately in a Phase 2b multi-center, open-label, repeat dose, dose-finding trial in Europe in CKD patients who are not on dialysis and who have not been treated previously with erythropoietin.

About Hematide™
Hematide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), has a completely novel amino acid sequence that is unrelated to erythropoietin, a hormone that stimulates red blood cell formation, or to any other known naturally-occurring human sequences. Compared to therapeutic proteins, Hematide has the potential advantages of an uncomplicated chemical synthesis, a simple dosing schedule characterized by monthly administration, and room temperature storage. In addition, antibodies generated to erythropoietin do not cross-react with Hematide, providing a rationale to study Hematide in patients with pure red cell aplasia (PRCA), a rare autoimmune disease caused by development of antibodies to recombinant erythropoietin. A Phase 2 study to evaluate Hematide in PRCA patients is scheduled to begin in early 2006. Hematide is being developed by Affymax to treat anemia in kidney disease and cancer patients.

About Anemia Associated with Cancer
Anemia, a deficiency of red blood cells, is becoming increasingly prevalent in the United States. Anemia is a frequent and serious complication associated with a number of increasingly common and severe diseases, including cancer, CKD, and cardiovascular disease. It can also occur in patients with other chronic diseases that cause inflammation, infection, or bleeding.

Severe fatigue associated with anemia affects more than 75 percent of all cancer patients undergoing chemotherapy. Anemia can cause cancer therapies to be less effective, can compromise the ability of patients to complete chemotherapy regimens, and can diminish their quality of life.

ESAs have been used successfully to manage anemia in patients with CKD and cancer-related anemia, constituting a $12 billion market worldwide. ESA therapy has dramatically reduced the need for blood transfusions and the frequency and severity of anemia-associated morbidity, resulting in an improved quality of life for patients.

About Affymax
Affymax, Inc. is a clinical-stage pharmaceutical company that is developing a rich pipeline of synthetic peptide-based drugs against clinically validated targets for the treatment of kidney diseases and cancer. Hematide™, the Company's first product candidate to enter the clinic, is a novel peptide-based drug designed to stimulate the production of red blood cells. It is in Phase 2 trials for the treatment of anemia associated with chronic kidney disease and cancer.

Contact

Mary Fermi
Affymax, Inc.
Senior Director, Commercial Development
650-812-8722

Media

Daryl Messinger
WeissComm Partners
415-999-2361
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SOURCE: Affymax, Inc.

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