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Biotech / Medical : Somatogen (SMTG)
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To: Bharat H. Barai who wrote (312)10/29/1997 7:52:00 PM
From: Timothy Kross  Read Replies (1) of 442
 
Dr. Barai, I am a new person to the Somatogen thread. Your comments on the yearly shareholders meeting at Boulder were very valuable to me. I thank you for so generously sharing your thoughts about the development of OPTRO with us.

I had been concerned about the pancreatic enzyme issue that had been discussed before.
Several months ago I wrote a letter to Dr. Maureen Viele, M.D. who authored a paper in regards to recombinant human hemoglobin
and renal function in humans. That reference is Anesthesiology 1997; 86: 848-858. My question to her was in regards to pancreatic enzyme elevations that were noted in the subjects that she discussed in her paper. The conclusions of her paper were that amylase and lipase elevations in six subjects were related to the inhibition of the nitric oxide pathway. She concluded that inhibition of nitric oxide pathways by the hemoglobin administration in the rabbit model abolished the relaxation of the sphincter of Oddi in response to nicotinic agents. She then speculated that this could be the cause for the
amylase and lipase elevations in humans, i.e. that sphincter of Oddi malfunction is caused by a lack of nitric oxide thereby blocking the nitric oxide related sphincter relaxation. Her paper gave several references in regards to
nitric oxide and sphincter of Oddi functioning in humans.

This issue caused me some concern so I wrote to her regarding it. One of her associates responded to me. He stated that to date there is no evidence that test subjects being given OPTRO to date have clinical pancreatitis and that CT scans of
the pancreas have been normal in recent subjects. This would suggest that enzyme elevations are occcurring without clinical evidence of pancreatitis. Of course her paper did not directly use CT scans to rule out pancreatitis.

I believe that her paper is the basis for Somatogen stating at the annual investor's meeting that nitric oxide binding is the cause for the sphincter of Oddi spasm that you alluded to in your report.

I reviewed the issue of pancreatitis in a number of medical gastroenterology textbooks. They indicate that a normal CT scan of the pancreas in any clinical setting where that diagnosis is being considered should alert the clinician to an alternate diagnosis other than pancreatitis.

My take on this is that clinical pancreatitis is not occurring in the vast majority of patients being given Optro, but that the final definitive pathological explanation for these enzyme elevations has not yet been written. Any thoughts that you may have or any new information obtained at the recent shareholder's meeting would be appreciated.

Best regards,

TJK
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