Wednesday, July 1, 2009

Ad blockers pt 4

Previously:Despite evidence presented that Advexin was safe, gene therapy in general was described as cursed in this 2005 Nature Biotechnology piece
"Because gene therapy has such a nasty reputation, people tried to rename it or call it 'new and improved' to free themselves of the stigma," says Michael Zasloff, an analyst with Ferris, Baker Watts of Washington, DC. "That may fool the public, but the market sees through it," he says.
Nevertheless, Nature Biotech wrote:
The first gene therapy approved in the US will most likely be Austin, Texas−based Introgen's Advexin, which delivers normally functioning p53 to cells.
Advexin was safe, and was in phase 3 trials. As noted in part 3, Introgen was planning to submit Advexin to the FDA for approval in 2004. Those plans changed...Introgen finally submitted their BLA in 2008, a few weeks after announcing a joint venture with the Texas A&M System.

This followed presentation of long-awaited phase 3 trial data at a cancer conference, which MD Anderson headlined as
Gene Therapy Increases Survival for End-Stage Head and Neck Cancer
There was some fine print
The trial showed that p53 expression in the patient's tumor before treatment is a reliable biomarker for how to treat head and neck cancer. Patients with a favorable p53 profile who received Advexin® had a median survival of 7.2 months, compared with 2.7 months for those whose tumor expressed high levels of mutant p53 before treatment. Patients with this unfavorable profile were better off taking the chemotherapy drug methotrexate, resulting in median survival of 5.9 months.

Potbangers in the biotech stock analysis community were not impressed, and predicted that Advexin would not be approved. The market agreed, and Introgen's stock plummeted.

The potbangers were right this time. The FDA told Introgen its application was "incomplete". By the end of 2008, Introgen filed for bankruptcy and David Nance had stepped down as CEO. Since then, Nance resigned from the Introgen Board and has resurfaced at a nonprofit to promote high-tech business in Texas.
David Nance says Texas could do a far better job of creating high-tech jobs and companies if the state's fiercely competitive regions and universities had a better way to work together.
Vision 1920 points out that the agreement between Introgen Technical Services and the TAMU System doesn't involve paying ITS (now renamed Vivante) anything - it's just a memorandum of understanding to apply for grants together from the Emerging Technology Fund, the Texas Enterprise Fund and the Federal Government.

So, what's the problem?

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