Dear Friends,
I was in Boulder today for Somatogen annual meeting. I asked lot of questions along with other people. Andre DeBruin made very good presentation about the company, ongoing trials, future Hb molecules and partnership plans. I also visited the manufacturing facilities and R & D lab, along with my friend Dr. Peter Mavrelis, a Gastroenterologist. Here is summary of our impression:
(1) The ongoing CPB trials are progressing well with no untoward side effects. The accruals are almost completed for the first phase. The second phase will start soon, to be completed by spring of next year.
(2) the full data of the trial WILL BE AVAILABLE next spring/summer but interim data MAY be available later this year. Our impression is that data should be positive, based on self confidence and smile on Andre's face, while talking about it.
(3) The data for Hematopoesis trial may be available later this year. I must caution that the basis for conducting Optro trials in end stage Renal patients and Myelodysplastic patients is very thin. In fact,at the meeting, I questioned the scientific basis for even conducting such studies. I think it is OK to do such exploratory studies, but I would not count much, if anything out of these studies.
The main use of 1st generation Optro will be in surgical patients. The second generation Optro will be useful for patients in acute blood loss situation. The reason for minor GI discomfort is identified as small nitric oxide binding. The same is probably responsible for spasm of sphincter of Oddii and mild transient elevation of Pancreatic enzymes. These problems should be resolved with 2nd generation Optro.
It is very clear that with genetic engineering, Somatogen can make number of alterations in the molecule and achieve various objectives. These changes are made at Gene level, not at Hb level. The technology at Somatogen is exceptional. Most people will find it beyond their ability to understand this very complicated and sophisticated molecular biology and genetic engineering. No other company has genetically engineered Hb and are no match for Somatogen's ability to produce the Hb in quantities or make modifications in Hb molecule to achieve various objectives.
After kicking the tires at Boulder, I fell very reassured about the management and the scientists, their committment, and the product. It is going at best possible rate and they have come very far along. Donot expect FDA filing before 2nd half of 1999. The technology and products are exceptional. This is beyond comprehension of most people on Wall street, who are looking for quick results. However, when the technology will translate into FDA approvals, They will listen, listen very carefully.
A word about partner: Andre stated that they have had intensive discussions with many US and foreign companies. Somatogen's presentation to them have impressed them. Andre stated that they are far more advanced in their talsk with 2 of such companies. My GUESS!!
AMGEN, Novartis, Roche. The partnership will be announced in "Next few months"
In conlusion: Science and technology of Somatogen are superb, If one has patience and long term vision, stick with Somatogen. Otherwise, there are other opportunities in investments.
B. H. Barai MD
Hematologist |
