>>Affymax(R) Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide(TM) for the Treatment of Anemia
Monday June 25, 8:00 am ET
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY - News) today announced that additional Phase 2 clinical trial results for Hematide(TM) were presented at the European Renal Association-EDTA Congress being held in Barcelona, Spain by Iain C. Macdougall, M.D., a Hematide investigator from Kings College, London. Dr. Macdougall's poster included data in previously-treated dialysis patients and treatment naive, non-dialysis patients which demonstrated that mean hemoglobin (Hgb) levels could be maintained and corrected, respectively, with once monthly Hematide.
Specifically, the data showed that in non-dialysis patients an initial range of doses from .025 mg/kg to .075 mg/kg of Hematide, in conjunction with dose adjustments, is adequate to increase Hgb in anemic patients with renal failure when administered monthly. In addition, intravenous and subcutaneous dosing appeared to result in a similar Hgb increase.
"These data support further investigation of the versatility and flexibility of once-per-month Hematide in terms of starting doses and route of administration," said Robert Naso, Ph.D., executive vice president of Research and Development at Affymax. "These results demonstrate that a narrow target range of hemoglobin levels can be reached with different initial Hematide doses. We are pleased to have such thorough evaluation of the product as we prepare for pivotal Phase 3 clinical trials."
At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 179 patients who had mostly completed six months of treatment at European and U.S. clinical sites. Of those, 89 treatment-naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to greater than 11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patients previously treated with Epoetin alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1.0 g/dL at the end of six months of treatment. Hematide was generally well tolerated and compatible with adverse events usually observed in patients with chronic kidney disease, with 6 percent of patients reporting adverse events possibly related to Hematide such as fatigue, rash and hypertension and 0.7 percent of patients reporting serious adverse events possibly related to Hematide (one transient ischemic attack in a patient with history of atrial fibrillation, and one moderate infusion reaction in a patient who responded to outpatient intervention).
About Hematide
Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in patients with chronic renal failure and cancer patients receiving chemotherapy.<<
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AFFY is testing its lows since going public on this news. Probably because the data on switched patients involves metrics the FDA and oncology community may not be so interested in. In other words, a baseline Hgb level of 11.5 +/- 1.0 is near the top of the range considered acceptable these days. What will the FDA do with this? I am sure there will be discussion with the FDA regarding the P3 design, and I would guess the endpoints will be a little different. As such, this trial may not be too predictive of success or ow hurdles for the P3 program. Further, by the time AFFY gets to market, there will be what, 3 or so years before epoetin goes generic in the U.S.? Already is generic in EU.
Amgen appears to be shaking off a downgrade today by Lehman, a long time bull on the company. I think some are weirded out by the munch of Alantos. Honestly, who needs another DPP-4 inhibitor (my answer: only OSIP)? I don't like it myself. The Ilypsa munch makes more sense.
Cheers, Tuck |
