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Biotech / Medical : Somatogen (SMTG)
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To: aknahow who wrote (357)1/15/1998 12:04:00 PM
From: JMarcus  Read Replies (1) 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.
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