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Allozyne Passes First Clinical Trial, Dreams Big About a Once-Monthly Multiple Sclerosis Drug

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to the longer-lasting interferon in development from Biogen, Chhabra showed a chart with results from a similar study that Biogen presented at the American Academy of Neurology in 2009. The trial showed that the long-lasting interferon from Biogen was active in the bloodstream for about seven days. Based partly on that result, Biogen is conducting a pivotal, Phase III clinical trial designed to see whether that provides enough drug, over a long enough time, to make it so injections are taken once every two weeks or once a month.

So the Allozyne drug appears in an early study to last 14 days, about twice as long as Biogen’s seven days. It’s too early to say whether that really adds up to much of an advantage in dosing convenience.

Allozyne still has a lot of work to do before it can say it has a competitive edge. To keep pushing for a bigger advantage, the company is working on a new biotech drugmaking process in which it performs a critical protein purification step before polymers are added, instead of after. It’s likely some impurities snuck their way into the drug in its first iteration in this trial—the kind of impurities that can provoke an immune system reaction that leads to flu-like symptoms, Chhabra says.

By performing this more rigorous purification process—which is common for a drug in Phase III, Chhabra says—Allozyne hopes to reduce the flu-like symptoms and make the drug last even longer in the bloodstream. The new, reformulated AZ01 is currently being tested in another study among 40 healthy volunteers, which should generate results before the end of June, she says. If that study goes well, Allozyne intends to move ahead with an aggressive study, designed to measure the drug’s safety and effectiveness, that would compare its drug to one of the existing interferons, and enable the company to reach the market in late 2016 or early 2017.

But to hear Chhabra tell the story, AZ01 is just one piece of the puzzle. She says she has spent months in talks with Big Pharma partners who are looking to enter the MS market, and she intends to offer them not just one product, but several. Besides AZ01 as the long-lasting interferon, Allozyne is moving toward clinical trials with a so-called “bispecific” antibody called AZ17 that hits two targets on cells instead of one. And Allozyne is in the final stages of obtaining a license to an oral pill for MS that has already passed through initial clinical trials.

That takes money, obviously. Back in July, Chhabra said she had received financing “commitments” from her company’s original venture backers—MPM Capital, OVP Venture Partners, Amgen Ventures, Arch Venture Partners, and Alexandria Real Estate Equities—who pumped in $30 million in October 2007. She repeated that line, and added she expects a large strategic investor to join a round of financing worth $40 million. Some of that money will be used to obtain a license to the oral MS pill in development, she says.

Those are two very important deals to pull off for a small company like Allozyne. It’s definitely a bold set of objectives for 2011, and a big test for Chhabra to see if she can clinch those deals at the big annual gathering of dealmakers in San Francisco. “This is a very important meeting for us,” she says. By building up the portfolio, she is betting that she’s creating something a lot more valuable to acquirers, or to potential IPO investors.

“This strategy increases the value of the company, and increases the likelihood of an exit in the short term,” Chhabra says.

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  • carol schumacher

    This is welcome news, however, Prof. Paolo Zamboni of U. of Ferrara, Italy published in Dec ’09 important research showing that nearly 100% of MSers suffered stenosis of the jugular and azygos veins. This has taken the MS world by storm and over 10,000 pts have been treated worldwide. Dr Mike Dake @ Stanford is beginning a clinical trial, as are others. The ISET.org meeting in Miami Jan 16-20 and SIRweb.org meeting in Chicago in March, Also Zamboni will host a meeting in Bologna in March ISNVD.org. For more info on this discovery go to ccsvi.org.