By Mary Welch

An anticancer drug already approved in Russia started Phase I/II trials in the United States for late-stage non-small-cell lung cancer.

The drug, BAM-002, is being developed and marketed in this country, Japan and Europe by Novelos Therapeutics Inc., of Newton, Mass.

"My family immigrated from Russia about 20 years ago and my father is a venture capitalist who has started several companies there, particularly around St. Petersburg," said Harry Palmin, the company's president. "He became close with the inventors of this technology and started filing patents in Russia. Novelos was formed in 1996 in the U.S. BAM-002 is the first drug to come out of this research."

Novelos has exclusive intellectual property and marketing rights to the technology platform, as well as future products developed by the Russian company, BAM Ltd.

The Phase I/II trial will involve about 10 centers, with the first being the Florida West Coast Research Center in Tampa. About 84 patients will be enrolled in the trial comparing BAM-002 plus chemotherapy to chemotherapy alone. It also will evaluate the safety and efficacy for a combination of intravenous and intramuscular delivery and a combination of intravenous and subcutaneous delivery of BAM-002.

The study's endpoints include tumor response, one-year survival and hematopoeitic recovery following chemotherapy. Any disease-related complications will be assessed as well.

"We were very pleased that the FDA accepted the data from our Russian studies as part of our IND [investigational new drug] application," Palmin said. "But the drug is getting a lot of acclaim in Russia. We know it works and it's safe. More than 2,000 patients in Russia have received the drug. It would be more but it's very challenging getting mass distribution in a difficult bureaucracy where the government changes every six months."

BAM-002 is a proprietary form of a peptide that is found in all cells of the body. It naturally exists in two forms, oxidized and reduced. In its oxidized form, excess amounts of the peptide are able to exert direct and indirect antitumor effects, protect normal cells against the effects of toxic agents, promote hematopoiesis and stimulate the immune system, the company said. Novelos' formulation stabilizes the peptide in its oxidized form.

In a controlled clinical study of BAM-002 in Russia in 68 patients with Stage III and IV non-small-cell lung cancer, 64 percent of the patients who received the drug with chemotherapy survived for more than one year compared to 15 percent of those receiving only chemotherapy. In addition, blood and immune system measurements commonly used to monitor the toxic effects of chemotherapeutic agents normalized more rapidly in patients receiving BAM-002 than in patients receiving chemotherapy alone.

While the one-year survival rate for all stages and types of lung cancer has increased to about 38 percent using chemotherapy alone, the average five-year survival for all lung cancer is about 14 percent.

"The thing to remember is that BAM-002 is part of a platform, and we expect to pursue other indications as well," Palmin said. "We expect interim results from our Phase I/II trial this fall, which will be two months after the last patient is enrolled."

The interim results are expected to bring much-needed benefits to the company: marketing partners and credibility.

"We are a private company funded by the founders and angel investors," Palmin said. "Once the results come out, we are sure that pharmaceutical companies would be interested. The key hurdle for us has been credibility in the U.S. I know this trial will allay those issues. As soon as we have those results in the fall, we'll have the credibility."

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