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Biotech / Medical : Introgen Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (56)	5/11/2004 7:05:12 PM
From: zeta1961	Read Replies (2) \| Respond to of 802

>>>>>>>Ouch!<<<<<<<<<< Actually...there's history to this...analysts have been hassling them since last year about disclosure of P3's...and INGN has persistently told Cowan, and all...NOT until BLA submission, they don't want to jeopardize the integrity of the trial, given that these patients have 3ish month median survival...you should listen to the February call for a real OUCHIE...if you think this was an OUCH... For some historical perspective...INGN is basically a spin off of M.D. Anderson which has made it a priority to develop gene based therapeutics for cancer and other diseases...INGN IPO'd in 2000...soon after Jesse Gelsinger's death....everyone was down on gene therapy...politicians, citizens were trying to stop it's IPO...yet, they already had done some early P1's in lung, head and neck at IPO...through much hassle, they did get to IPO...then in 2002 the French study where the X-linked scid children....2 of 10 cured children developed cancer...although it was a retroviral vector transducing the cell which Advexin does not...it was still a blow to gene based therapies... INGN has chosen an orphan condition...advanced head and neck cancer...in a heavily pretreated population with no other options...It's becoming more apparent to me that given the negative history, they've had trouble accruing patients on time...accrual was supposed to be complete by end of 2003.... Because I've worked at Harvard and have participated or been aware of sensitive clinical trials...I happen to give them more slack than your average investor about the non-disclosure of P3's...my biggest proxie is M.D.Anderson's involvement...this is the top cancer center in the world...Dr. Mendelsohn their president got much flack for being involved with IMCL...he discovered erbitux....Max Talbot, INGN's regulatory affairs person worked at the FDA and in industry and has sheparded at least 15 products through the FDA process... Insiders own 60%....so, if they are lying...they have the most to lose...and more than that M.D. Anderson has the most to lose...in reputation, credibility...so, I really don't believe they are hiding bad data...I like their P2 data indicating an 88% survival advantage...the P3 population is the same...heavily pretreated with no options.... They did mention accelerated approval based on surrogate endpoints...they've alluded to this in the past...so I don't know... The main thing I'm disappointed with is that they've pushed their guidance for "beginning" BLA submission 2004...for the last year they've been guiding "BLA submission in 2004"... Ian, certainly not trying to get you in...definitely high risk...yet their data is too compelling for me to ignore...they have a patient that's still alive 7 years post Advexin for end stage lung cancer...their P2's on lung are very good warranting P3 registration...but they don't have the cash to do so...they are the de facto experts for the FDA re: gene based therapeutics, they've written the reference manual for adenoviral vector production...Schering was a thorn in their side in Europe...we learned from this conference that issue is resolved...so should help in negotiations... This is a team of prior successful businessmen running this company with the U of T, M.D. Anderson, the American Cancer Society, the NCI funding 24 human clinical trials... Lastly, another proxie I am using: INGN's trials are overseen by the NCI's Recombinant Advisory Committee(RAC) and a Data Safety Monitoring board...since this is gene therapy...INGN's P3's would have been halted by now if 1)there were safety concerns(none)....2)very importantly if they were showing no efficacy...it would be too risky and too unethical to allow these trials to continue since there are other clinical trials these patients could seek.. Not trying to get you in....just explaining the reason behind what you and most people think is an insane investment.... :) Zeta...