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Biotech / Medical : Somatogen (SMTG) -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (357)	1/15/1998 12:04:00 PM
From: JMarcus	Read Replies (1) \| Respond to of 442

Dow Jones Newswires -- January 15, 1998 Somatogen Begins Trial Of Optro For Cardiac Surgery BOULDER, Colo. (Dow Jones)--Somatogen Inc. (SMTG) enrolled 31 patients in Part A of its Phase II clinical trial of Optro recombinant human hemoglobin in cardiac surgery. In a press release Thursday, the company said patients underwent acute normovolemic hemodilution with Optro prior to cardiopulmonary bypass. Somatogen will increase the size of the Phase II trial by adding patients at the 2, 3 and 4 dosee levels. The change is intended to provide a stronger basis for the design of a pivotal study which is expected to involve about 400 patients. The company expects the trial to conclude by the fall. Somatogen also completed patient enrollment and analysis of results from two studies examining potential for rHb1.1 to stimulate hematopoiesis in patients with chronic anemia. In one study, 11 patients with bone marrow suppression were divided into three different dose groups for eight weeks, followed by eight weeks of observation. Ten of the patients had primary bone marrow failure due to myelodysplastic syndrome and one had metastatic disease from a primary liver tumor. Two of the 11 patients receiving rHb1.1 had a reduced need for red cell transfusion, one of the predetermined indicators of a potential hematopoietic response. In another study, 48 patients with end-stage renal disease were divided into two different rHb1.1 dose groups or a placebo group for eight weeks, followed by eight weeks of observation. All patients were given optional doses of Epogen. No evidence of hematopoietic effect at the dosage levels administered was noted in this study. The chronic dosing of rHb1.1 in both of these patient groups was assessed to be safe at all doses examined. No signs of immunological reactivity were observed, the company said. Somatogen is a biopharmaceutical company specializing in genetically engineered recombinant human hemoglobin-based products.

To: aknahow who wrote (357)	1/16/1998 12:01:00 AM
From: Bharat H. Barai	Respond to of 442

Hematopoesis trial results were not surprising. I have repeatedly written on this thread that I would be surprized if they showed positive results. The trial design was wrong. I had pointed that out at the last annual meeting also. Why was the design wrong: (1)One group of patients had bone marrow damage, due to myelodysplastic syndrome. Here the marrow is damaged and even EPO does not work in most cases. It was unlikely that Optro will work in similar situation. (2) In the second set of patients with end stage renal disease, Optro was given with EPO Vs EPO alone. If the marrow was stimulated with EPO, you will see little additional stimulation with Optro plus EPO. In my opinion, the proper design will be to use Optro for 4-6 weeks in end stage renal patients and check for increase in Hb. No harm comes to patients if they are not receiving EPO. Before EPO came, what happened? Some got blood, others just survived, feeling tired. The Cardio Pulmonary studies results are still pending. They should come OK. Their second generation molecule should be put in clinical studies ASAP. Once Nitric Oxide binding related problems disappear, it will find much better and quicker acceptance. B.H. Barai MD Hematologist