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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?


To: Mark A. Voelker who wrote (883)5/1/1998 1:11:00 AM
From: Stephen How  Read Replies (1) | Respond to of 1432
 
Mark,

I'll try to get a copy of the Bick paper from Biotime. I contacted the publisher for reprints, but haven't yet received it.

There have been many papers studying the effect of hydroxyethyl starch (HES) on coagulation (http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=4&db=m&term=hetastarch%5DAND+coagulopathy&dispmax=100&relpubdate=No+Limit).

Hetastarch induced coagulopathy is the big issue here! This is at the center of the whole controversy over the added-value of Hextend&reg over Hespan&reg! I hope there is no confusion over this! If Bick concluded there was no HES induced coagulopathy, then it only categorizes him in the "no coagulation effect" category (recall the 4/18 other "no effect" studies).

I think I've stated my views on Hextend&reg clearly here, and on my webpage. My estimation of the product, the stock, and the controversy have been constant since I started my webpage. All of the facts and developments surrounding this stock seem perfectly consistent to me. Even though people seem to express dismay over the recent events, I'm pretty sure everyone understands the doubts about the product's value.

Steve

btim.dyn.ml.org

P.S. The Anesth Analg paper did not cite the Bick paper. It cited 43 references, including the 3 specific references for the HES coagulopathy mechanism paragraph. The Bick paper wasn't cited, since it was not an original reference on HES, except for it's study of Hextend&reg.



To: Mark A. Voelker who wrote (883)9/13/1998 2:41:00 PM
From: mesaone  Respond to of 1432
 
Mark,

I am sure you won't mind my reprinting your analysis of the FDA's official response to the British Medical Journal's article on Albumin and how it can lead to increased fatalities among critical care patients. By proclaiming that albumin is high risk, the FDA is certainly going to be diligent about trying to approve a safe substitute to albumin. You and I have always been in agreement that the market size for Hextend is not limited to the hespan market, but includes the albumin market. In light of the FDA's cautionary notice to the medical community, I would hope that FDA approval for Hextend will be forth coming before the end of this year... and hopefully sooner.

inch.com

The complete article from the British Medical Journal and the FDA's dear doctor letters have been linked to my web site. I am a long biotime shareholder and am not employed by BioTime.



To: Mark A. Voelker who wrote (883)9/13/1998 2:45:00 PM
From: mesaone  Read Replies (1) | Respond to of 1432
 
reprinted from the Yahoo message board.

In an official "Dear Doctor" letter, the FDA today warned doctors of the increased risks of using albumin
and PPF (plasma protein fraction) and "urged treating physicians to exercise discretion in the use of
albumin and PPF". The FDA issued this warning after reviewing the recent articles in the British Medical
Journal (BMJ) which reported a 6% increase in mortality associated with the administration of albumin
and/or PPF.

"It is FDA's current view that the cited studies warrant serious consideration. FDA encourages additional
controlled trials on the use of albumin and PPF and is committed to working with the product
manufacturers to determine whether the label indications for albumin and PPF should be revised. Until the
results of further, well-focused studies are available, the FDA urges treating physicians to exercise
discretion in use of albumin and PPF based on their own assesment of these data."

At present, there are three choices available to doctors to treat hypovolemia (shock) and other indications
for plasma volume expansion: crystalloids (salt water and Ringer's lactate), generic hetastarch in saline
(Hespan), and albumin. Crystalloids cause edema, a life threatening condition. Hespan causes coaguation
problems when used in amounts above about one liter. And now, albumin has been shown to cause
increased mortality.

The only other possible solution close to reaching the market to treat hypovolemia caused by trauma or
surgery is BioTime's Hextend, which has been shown to be safe and effective in Phase III clinical trials.
Hextend also demonstrated superior coagulation performance and required use of less blood products
(including PPF) in these trials in comparison to Hespan. These results were reported in a poster paper
presented last January at the Anesthesiology conference in San Juan, Puerto Rico.

I expect a peer-reviewed paper describing in detail the results of the Phase III trials to be published in a
scientific journal before the end of the year. Some of the data in this paper (not shown in the poster paper)
demonstrating superiority of Hextend was examnined by me at BioTime and may be shown to BTIM
shareholders if they visit the company.

Paul Segall stated in a past press release that he expected the marketability of Hextend to be decided by the
end of the year.

Hexted is, of course, presently being evaluated by the FDA for marketability in the US.

September should be a very interesting month for BioTime shareholders.

--Mark A. Voelker, PhD
(Speaking for myself as a BTIM shareholder since 1995.
I am not nor have ever been an employee of BioTime.)

mesaone's website can be viewed at:
inch.com