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aslan2772

09/14/06 12:14 AM

#409 RE: DewDiligence #404

"Putting an experimental drug into an experimental delivery platform incurs regulatory headaches that many companies would rather not address. "

Point taken. Both BSX and JNJ took that approach with DES, but MDT, ABT, and GDT have not, probably because the regulatory soil, so to speak, had been loosened by the former. By analogy, Novartis' remarkably stable (>30 year shelf life in the lab) PTK787 (Vatalanib) is a compound that SRDX might want to follow closely, as it is currently in PIII trials for cancer and PII for AMD. This small molecule has potential advantages over Lucentis, in that in addition to blocking all 3 isoforms of the VEGFR, it also prevents activation of these receptors by alternative ligands, for example PGF. I would caution that this ligand targets the ATP binding site of the tyrosine kinase moiety. In general, designing selective ligands for ATP binding sites of kinases can be challenging, although PTK appears to be quite selective (eg IC50 for VEGFRs is ~20 nM whereas IC50 for the related HER-2 and Insulin GFR-1 are > 10,000 nM).

BTW, I also wanted to note that SRDX's language pertaining to I-Vation/InnoRx technology licensing had not changed Monday at the ThinkEquity Partners G4 online presentation: multiple partnership talks including at least one major pharmaceutical company are still reportedly underway. I hope we get more clarity at the upcoming CL King and Associates Best Ideas Conference now that Phase-I data are in.
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north40000

09/14/06 1:42 AM

#412 RE: DewDiligence #404

For a different slant on this statement:

"We see this kind of reluctance also in the hepatitis and cancer arenas, where a cocktail of experimental drugs may be a compelling choice from a scientific standpoint, but no one is willing to undertake the clinical trials and each company instead pushes its own drug in combination with already-approved therapies."

readers might check slides 6 and 13 on the MEDX presentation
at Bear Stearns this past Monday:


http://cc.talkpoint.com/BEAR002/091106a_cy/linkdefault.asp?entity=medarex

Slide 6 shows 2 unapproved drugs----MDX-010 and MDX-1379---
in combination for melanoma, with complete responses now
extending past 40 months in some patients. SPA, I believe.

Slide 13 shows 2 unapproved drugs---MDX-066 + MDX1388---
in Phase II trials initiated in 09/06 against toxins A and
B of C. Difficile.