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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: VLAD who wrote (16642)12/4/1998 12:49:00 PM
From: DaiS  Read Replies (1) of 23519
 
Gene therapy

Vlad,

I am not aware of an imminent publication on the gene therapy work. Probably when NF mentioned this she had in mind conference presentation and abstract. Let us be patient on this.

I can tell you on good authority that,

1. The team will be presenting exciting new observations on preservation of erectile capacity using hslo DNA in experimental diabetic rats at a gene therapy conference in the second week in January 1999.

2. Recent research has established that, in general, injection of naked DNA results in a rate of integration four orders of magnitude below the frequency of an oncogenic event and three orders of magnitude below the spontaneous mutation rate. Thus insertional mutatagenesis is unlikely to be a major safety issue in gene therapy for ED.

3. Of more concern from the safety viewpoint is ensuring a suitably efficacious tissue distribution of the injected naked DNA (by analogy with the IC practice of injecting both sides of the penis). The team has encouraging preliminary data on this that will be presented at another meeting in the spring and also possibly at the next AUA.

3. "Gene therapy will never be approved for ED until approved for something life threatening like cancer." The team reject this view totally. Because of the unique or fortuitous features of ED gene therapy, it is felt the this work might well define the boundary conditions for future gene therapy of many other disorders.

I don't want to hype. I feel that there is good possibility of a therapy but there is still a long road to go. Most important it seems to me is that it is something that Vivus can take advantage of in negotiations.

DaiS
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