Elephants stampeded into GenVec late in the trading session when the following was released simultaneously with the presentation referenced therein (thus avoiding Reg. FD issues):
These seem to be pretty good results for a dose ranging study in which MTD was not hit. Pancreatic cancer is hard to treat in part because it's hard to catch early, and the prognosis is generally not good.
>>GAITHERSBURG, Md., Jan. 23 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), announced that Nader N. Hanna, M.D., Assistant Professor of Surgery, Surgical Oncology, University of Kentucky Medical Center, will present new data on GenVec's lead oncology product candidate, TNFerade(TM), at the 2004 ASCO Gastrointestinal Cancers Symposium being held this week in San Francisco, California. As previously announced, the oral presentation entitled "Safety and Efficacy of TNFerade(TM) in Unresectable, Locally Advanced Pancreatic Cancer (LAPC): Results From the First Three Cohorts of a Dose-Escalating Study," is scheduled to take place today at 12:15 p.m. (Pacific) during the Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract session of the meeting. The poster will be displayed during a general poster session this evening from 5:30 p.m. to 7:00 p.m. (Pacific).
"We are excited about the pancreatic cancer data. TNFerade continues to demonstrate a favorable safety profile and these new data from the third cohort of patients further supports a dose related improvement," commented Paul D. Kessler, M.D., GenVec's Executive Director of Clinical Research. "Based on our results to date, we anticipate adding a fourth cohort of patients to be dosed at 1x10(12) pu to the study in the near future. Upon establishing a dose, we are optimistic about moving TNFerade into a pivotal, randomized, controlled study," Dr. Kessler concluded.
Dr. Hanna's oral presentation and the poster provide an update on the use of TNFerade as front-line therapy in combination with radiation and chemotherapy in patients with locally advanced pancreatic cancer. Data highlights include:
* TNFerade was well tolerated when administered by either endoscopic
ultrasound or percutaneous injection directly to the tumor. The maximum
tolerated dose was not reached and an additional cohort of patients to
be treated at 1x10(12) pu is anticipated.
* The percentage of patients who were progression-free at 3 months post
treatment was 25% in the 4x10(9) pu cohort, 50% in the 4x10(10) pu
cohort, and 67% in the 4x10(11) cohort.
* Normalization of CA19-9, a protein marker for pancreatic carcinoma, at 3
months post treatment occurred in 44% of the patients at the 4x10(9) pu
and 4x10(10) pu dose levels compared with 83% of the patients at the
4x10(11) pu dose level.
* Local tumor response (greater than 25% shrinkage) was seen in 4 of the 6
evaluable patients at 3 months post treatment at 4x10(11) pu.
With an estimated 33,000 new cases diagnosed annually, pancreatic cancer is the fifth leading cause of cancer deaths in the United States. Approximately $600 million is spent on the treatment of pancreatic cancer each year.
GenVec is a publicly held biopharmaceutical company developing novel therapies that improve patient care in the areas of cancer, heart disease and vision loss. GenVec also has funded vaccine programs for HIV, SARS, malaria and dengue virus. Additional information on GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.<<
snip
This seems to compare well with, say, Gemzar as monotherapy, with the TNFerade cohort mostly ahead of those in this trial:
asco.org
With the usual caveats about comparing trial results.
Cheers, Tuck |
