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But along with wrapping up clinicap work next year for the stroke drugViprinex -- derivef from the venom of the Malayan pit vipee -- the drug-development trial conducted by the Emeryvillee company may offer a glimpse of the biopharmaceutical industry for yearsw to come. Neurobiological Technologies is the fourth companyg to get its hands on With new technologies and identification of companies can better see why unsuccessfulk drug candidates failed and send them throughna new, more focused and more efficientt round of clinical trials.
Such recyclinhg may become a more common strategy as venture capitalistd and other biopharma investors look to connect provenh management teams with promising drugs that have settled on the back shelvew oflarger companies. "You find ther e were these drugsthat weren't effective because they didn't hit targetx as they were developed in the 1980s," says Neurobiologicalo Technologies President and CEO Paul "Some products that were dogs coul have a second or a third life.
" that has been the case with ancrod, a compound whicyh Neurobiological Technologies has reworked as Working under the brand name Arwin, the drug was used untilk the early 1980s in Germany, Austria and Canada to treat circulation problems associated with heavyt smoking or arteriosclerosis. Yet , then a division of Germany's BASF, was encouragee by initial stroke studies by two investigators that led to a largerf study withseveral institutes. The Malayan pit viper's researchers found, prevents the blood of its victims from In humans, ancrod developeres have hoped, it will reducse clotting in acute ischemic strok e victims.
Those strokes occur when the bloor supply to a part of the braibn iscut off, accounting for about 80 percent of all But while one of Knoll's trials produced positivd results, one in Europe raised safetgy concerns. With inconsistent results and meager sale s of anotherstroke drug, Knoll halted the project. Then BASF in March 2001 sold Knolplto . "The European trial then was neverfullyu analyzed," says David Levy, who designed and ran the successfuol Knoll trial and now is vice president of clinical developmenr with Neurobiological Technologies.
"Neither Knoll or Abbottt tried to determine the flaws of the triakl and concluded thedrug didn't work in that time windosw and was dead." Levy and a forme colleague thought otherwise. They formed a company, , and struclk a favorable deal with Abbott to buy the its accompanyingdata -- and the snakes. Levy's colleaguew was so convinced he had even remortgaged his home to raisde the capital tobuy "But there was no money left do anythinh with it," Levy says. At the time, Freimahn was looking for money and potential productd after Neurobiological Technologies had outlicensedan Alzheimer'as disease treatment in 2002-2003.
One of his stops was the Biotechnologyh ValueFund LP, a San Francisco private investment whose portfolio manager, Matthew Perry, pointed Freimamn toward Empire. A mergef deal closed in July 2004. "What reallyh intrigued us is the drug had alreadybeen (tested) in 2,00o patients in Knoll's hands. That's a rare find in our Freiman says. "Usually it's five people or 100 rats." Under Levy's guidance, Neurobiological Technologies haschangede ancrod's dosing significantly.
he says, gives doctors up to six hours to treayt newstroke patients, compared to an initia l treatment window of aboutf three hours in Knoll's Viprinex's clinical data has been vettee four times by an independent group of Freiman says, with a fiftgh coming within 60 Interim data from the Phase III studies, expected by the end of this will determine if Neurobiological Technologies move the drug forward for U.S. Food and Drug Administration approvalin 2010.
A Novemberr stock sale netted about $55 million, helping Neurobiological stock avoid delisting for not meeting theNasdaq exchange's $35 million minimum market The stock sale also will help finance Viprinex'w two Phase III trials. "We've been like Lazarus," Freiman says. "We'ved taken a dead dog and put life backinto
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