Mike, my newest and greatest gene therapy stock is GenVec (gnvc). Phase 1 seems impressive to me; plus has one existing partnered program and mkt cap of $80m:
TNFerade Gene Therapy Causes Tumor Shrinkage at Lowest Doses During Phase I Clinical Trials
GAITHERSBURG, Md., Nov 6, 2001 /PRNewswire via COMTEX/ -- GenVec, Inc. (Nasdaq: GNVC chart, msgs), a biopharmaceutical company developing locally delivered gene-based medicines, today presented the first clinical trial data for its lead oncology product candidate, TNFerade. The interim Phase Ib clinical trial results were selected for oral presentation at the annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO) meeting in San Francisco and were given by the University of Kentucky's Dr. Nader Hanna, one of the principal investigators.
TNFerade delivers the human tumor necrosis factor alpha (TNF-alpha) gene directly to tumors, using GenVec's proprietary adenovector gene delivery technology. Once inside the tumor, standard radiation therapy triggers a "switch" known as the EGR-1 promoter initiating the localized production of the therapeutic anti-cancer protein, TNF-alpha.
Interim Findings from the Two Lowest Dose Levels (7 Patients Evaluable)
* Two out of seven patients (2/7) showed a Complete Response (CR)
* Two out of seven patients (2/7) showed a Partial Response (PR)
* Three out of seven patients (3/7) demonstrated Stable Disease (SD)
* None of the cancerous lesions treated with TNFerade plus radiation
progressed and each of them showed tumor shrinkage.
* The mean tumor shrinkage of TNFerade-treated lesions thus far in the
trial is 54%.
* In some patients, control lesions received the same radiation dose as
the injected lesions, but did not receive TNFerade. None of the
control lesions shrank.
Safety Findings from the First Two Dose Levels of TNFerade
(8 patients evaluable)
* Drug very well tolerated
* No Dose-Limiting Toxicities (DLT) seen
* No drug-related Serious Adverse Events (SAE) seen
* No changes in serum-TNF levels over pre-injection levels
* No adenovirus detected in blood or urine of patients
* No increase in antibody titer against adenovirus in 7/8 patients
* Two out of eight patients (2/8) experienced injection site pain and
three out of eight patients (3/8) experienced mild chills. No other
side effects were reported.
"An objective tumor response rate of 4/7 patients at the lowest dose levels is encouraging," stated Dr. Henrik Rasmussen, Vice President for Clinical and Regulatory Affairs for GenVec, Inc. Dr. Rasmussen continued, "TNFerade, administered by direct intratumoral injection, appears to remain inside the tumor environment with very little spillover to the bloodstream. The low serum levels of TNF-alpha (between 1-8pg/ml) indicate a substantial therapeutic index for TNFerade as these levels are approximately 100 to 1,000 fold below toxic plasma concentrations of TNF-alpha. We are further encouraged that TNFerade has been well tolerated, as dose-limiting toxicities are commonly seen in the clinical testing of new cancer drugs." (snip) |
