GNVC at ASCO:
Finding dose for pancreatic cancer; still not at MTD. Ditto for soft tissue sarcoma. Response rates for this stage look good in STS, while pancreatic cancer responders close to average of other treatments. But these are only interim results . . .
>>GAITHERSBURG, Md., June 2 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), a biopharmaceutical company, announced preliminary data from the dose escalation portion of a Phase II study using TNFerade(TM) in combination with chemotherapy and radiation in patients with locally advanced, inoperable pancreatic cancer. The results, presented Sunday, June 1st in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, indicated that TNFerade, when used in combination with standard chemotherapy and radiation, was well tolerated at the two dose levels evaluated to date. Local control or stabilization of the treated tumors was also seen in 11 of the 17 evaluable patients (65%) as reported by an independent radiology laboratory (4 partial responses, 2 minor responses, 5 stable disease). Following treatment, two patients with previously inoperable tumors were able to have their cancers removed surgically with no evidence of cancer in the surrounding tissue. One of these patients showed a pathological complete response (no evidence of viable tumor cells).
Dr. Kenneth J. Chang, associate professor of medicine, head of Gastrointestinal Oncology and director of the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine, commented on the outcome of the study, "I am pleased with the promising results of this study. This is a novel therapy with the potential to be a significant clinical breakthrough in the treatment of patients with pancreatic cancer."
The key goals of this dose-escalating phase are to select the dose and route of administration of TNFerade for the randomized portion of the Phase II study. Three doses of TNFerade (4 x 10(9) pu, 4 x 10(10) pu and 4 x 10(11) pu) and two routes of administration, endoscopy and percutaneous injection, are being evaluated.
The combination of repeated intratumoral injections of TNFerade, infusional 5-FU and radiation was well tolerated. The maximum tolerated dose has not been reached. One transient dose limiting toxicity, grade 3 hypotension, was seen at the second dose level (4 x 10(10) pu).
TNFerade(TM) uses GenVec's proprietary adenovector technology to produce the anti-tumor protein, tumor necrosis factor-alpha (TNF-alpha), at the site of the tumor.<<
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>>GAITHERSBURG, Md., June 2 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), a biopharmaceutical company, announced data from a Phase I clinical trial using TNFerade (TM) in combination with radiation therapy in patients with soft tissue sarcoma. The results presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, demonstrated that TNFerade was well tolerated with no dose limiting toxicity reported. Objective responses were seen in 11 of 13 (85%) evaluable patients. Two patients experienced a complete response and 9 patients had partial responses. Objective responses were seen in all 6 evaluable patients treated with the highest dose of TNFerade. The tumors treated were generally very large and typically do not respond well to standard radiation therapy.
Dr. Srinivasan Vijayakumar, Professor and Chair, Department of Radiation Oncology, University of California Davis Medical Center commented on the results, "In this study, TNFerade plus radiation demonstrated safety and feasibility with no unexpected complications. This combination therapy produced a very gratifying response confirmed at the time of surgery in approximately 85% of the patients. The response rate seen in this trial is greater than we currently see in clinical practice. Further studies to confirm these findings may lead to changes in clinical practice patterns and improvements in the outcomes and quality of life for patients with soft tissue sarcoma."
In this trial, TNFerade was injected twice in week one and once weekly in weeks two through five in conjunction with standard radiation therapy. Overall objective tumor responses were assessed by pathology review and/or radiological measurement. The overall objective response rate included patients with complete, partial and minor responses.
The Phase I trial was a safety study testing three doses of TNFerade (4 x 10(9) pu, 4 x 10(10) pu and 4 x 10(11) pu) in patients with soft tissue sarcoma of the extremities. This trial was conducted in patients scheduled to receive radiation therapy to reduce tumor size prior to surgery or to reduce symptoms in patients who could not undergo surgery to remove the tumor. TNFerade was well tolerated with no dose-limiting toxicities reported. The maximum tolerated dose was not reached.
TNFerade(TM) uses GenVec's proprietary adenovector technology to produce the anti-tumor protein, tumor necrosis factor-alpha (TNF-alpha), at the site of the tumor. Preliminary data from this trial were presented in November 2002 at the 14th EORTC-NCI-AACR Symposium "Molecular Targets and Cancer Therapeutics" in Frankfurt, Germany.<<
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Cheers, Tuck |
