Drum Roll, please!
The long awaited report on Introgen from someone who understands biology better than English. And his English isn't bad, really. With me, it's very much the other way around, so this is a special treat for my biofreak audience: analysis of a therapeutic BLUE HP candidate by someone far more qualified than BLUE HP's manager.
>>Stefaan on INGN
Links
Institute for Gene Therapy med.upenn.edu
Recap (study of alliances and trials) recap.com
Gene therapy intouchlive.com.
Trials
Product Target(s) Phase Status
Ingn 241 solid tumors 1 ongoing
Ingn 201 head + neck 2 done expected survival in radiation and chemo pretreated is 7.5m in INGN201 group
Ingn 201 lung 2 ongoing
Ingn 201 prostate, brain 1 ongoing
Ingn 201 ovarian, breast 1 ongoing
Ingn 201 bladder 1 ongoing
Trial Events, Notes, & Endpoints (prim = primary endpoint; sec = secondary endpoint)
Jun-00 Ingn 201 head + neck phase3 ongoing ends q4 03 T301 240 120 ingn 201 2/w injection in tumor prim survival
120 iv weekly MTX sec quality of life and time to progression
chemo and radiation pretreated mtx yield 4m
May-01 ingn 201 head + neck phase3 ongoing ends q4 03 T302 288 multicenter prim disease progression
1/2 INGN 201 + standard chem ie cisplatinum and 5FU sec endpoint quality of life and survival
1/2 cisplatinum and 5fu
recurrence after radiotherapy
injection in the tumor over 3d /3w each nodus injected 3 times ?
what is the min max size of nodus
chemo 1v 1/3w
interim analysis at 50% acrual
Questions /Concerns
why 2 phase 3 trials?
why is deal on Ingn 201 restructured and what are the terms
why other endpoints in t301 and t302
how is the patent position on P53 with GZMO
competing products IMCL and onyx (virus which only replicates in p53 defective cells ?)
The ONYX-015 adenovirus lacking the E1B 55-kDa gene selectively kills p53-deficient cancer cells, but produces clinical benefit in only about 15% of patients with recurrent, refractory cancers of the head and neck, according to Dr. Fadlo R. Khuri, of the University of Texas M. D. Anderson Cancer Center, in Houston, and colleagues. Disease also rapidly recurs with chemotherapy alone.
why is ingn201 already begun trials for prostate in 97 and not further along for the moment ?
as repeated doses are needed what are the chances that a immune response develops against the virus rendering it inactive
only 100K cases worldwide from which only 50% are p53 defective
Government /approval of therapy ??? What with the death last year
Gene Therapy Alive and Well, Despite One Death BIOWORLD Today via Gale Group
Oct. 14, 1999 BIOWORLD Today via Gale Group
Oct. 14, 1999 — In the wake of a fatality in a gene therapy program at the University of Pennsylvania, the FDA has ordered Schering-Plough Corp., of Madison, N.J., to halt two gene therapy studies that shared one key similarity: they used relatively high doses of adenovirus to introduce a new gene directly into the liver.
Competition Schering-Plough
Chang detailed his company's experience using adenoviral vectors with the p53 gene in cancer patients. Chang stressed that although his company is still using a first-generation adenoviral vector, E1-deleted, safety appears satisfactory, considering that his patient population are usually end-stage cancer patients.
Ingn datasheet
Price 5.89 MC 125m$
Hi 15.5
Lo 3.2
Cash 1.72 Book 1.99 Burn ?
Insider data
Stable: note Rhone Poulenc (now Aventis) has more than 10%
Products
INGN 201 lead product combination of P53 and adenoviral vector
Timeline for past & present issues:
Jun-00 start 1st P 3 trial on INGN 201 with Aventis
Apr-00 restructuring deal Aventis Ingn on P53 why ? Terms ?
May-01 start 2 P 3 pivotal trial with Aventis on head and neck cancer using p53/adenoviralvector
Timeline of known future events
??? interim analysis at 50% accrual
q4 2003 enrollment stops for both p3 trials on INGN 201<<
This report points to areas in which further digging would help, but biofreaks can use this as a first cut to decide if that effort is worth it. Many thanks to stefaan, who made good on contributing in exchange for my helping his wallet in a small way. For the rest of you, no guts, no glory. Keep an eye on DPII. Getting close to my nibble targets and cash value; looking silly cheap according to my research, noted here and on Trickle. I believe I set a nibble target of $5. Whatever it was, it's a limit order, and so are the others mentioned. If the ask gets below those targets, I will update the portfolio upon my return from THE Valley (Yosemite, leaving tomorrow, back next weekend). If I said chunk, that's ~$10K worth; half chunk about $5,000.
Cheers, Tuck |
