By Brady Huggett
StressGen Biotechnologies Corp. took another step toward the goal of getting its first product to market by initiating patient treatment in Phase III trial of HspE7 as an immunotherapeutic for anal dysplasia.
"I think the program is aggressive and moving at a great clip," said Daniel Korpolinski, president and CEO of StressGen. "Although there are broad-based opportunities for stress proteins in other markets, getting our first product into the market is key right now."
The double-blind, placebo-controlled study will involve 128 patients in two or three sites in the United States, Korpolinski said. The primary endpoint in the six-month trial will be a regression of the condition.
"We are trying to dial down from high grade to low grade and we're looking for partial and complete responses," Korpolinski said. "Enrollment has not been a problem. In our Phase II we enrolled much quicker than we anticipated."
StressGen, of Victoria, British Columbia, also has active Phase II HspE7 studies in women with human papilloma virus-related cervical dysplasia and cervical cancer and plans to initiate a Phase II study in genital warts.
HspE7 is a recombinant fusion product composed of heat shock protein 65 (Hsp65) from Mycobacteria bovis BCG fused to the protein E7. E7 is derived from HPV and is a tumor-specific antigen that represents a target for the immune system attack on abnormal cells. Different strains of HPV cause different conditions - HPV 16 can lead to cervical and anal cancer and HPV 6 and HPV 11 can lead to genital warts, an area in which HspE7 also has shown promise.
"Genital warts is a very large market opportunity," Korpolinski said. "There are a million new patients per year for warts. Since it's sexually transmitted, when you treat the patient, you also treat the partner. You get to sell twice the amount of drug that way."
Korpolinski said that StressGen has proof of principle with its technology and there are a variety of other diseases the company can attempt to treat, such as herpes and hepatitis B and C.
StressGen completed a public offering in October, raising C$45.5 million (US$29.9 million) to fund product development for HspE7. With that money in hand, Korpolinski said StressGen is ready to go forward.
"We're sitting with C$70 million in cash," Korpolinski said. "We have enough resources in people and money to put us in a nice position when we go discuss partnerships. But our goal is to get that product into the market.
"As far as partners go, we are looking for someone that can give us a global market, someone that can register the product and sell it around the world," Korpolinski said. He added that it might be beneficial if the company already is in the area of women's health or anti-infectives, but that characteristic is secondary to a worldwide reach.
Based on positive interim results, StressGen's Phase II trial was stopped before completing enrollment of all its intended 180 patients and the company moved straight to Phase III trials. Although HspE7 has been on a fast track, that doesn't mean it's ahead of the game. (See BioWorld Today, June 28, 2000.)
"We don't like to over-promise," Korpolinski said. "We feel we are right on our schedule. I hate to speculate [on HspE7's future] because there are many things that could affect its timeline, but maybe we are looking at 2004 for filing a BLA.
"We do think being in Phase III puts us in a different class of companies," he added. "Not everyone has reached Phase III."
StressGen's stock (TSE:SSB) moved up C45 cents Monday to close at C$7.50.