And another one.
Monday May 20, 7:25 am Eastern Time
Press Release
SOURCE: GenVec, Inc.
Gene Therapy Clinical Results Show Notable Tumor Shrinkage In Phase I Human Trials
72% of Patients Experienced Tumor Shrinkage from 25% - 100%
GAITHERSBURG, Md., May 20 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), a biopharmaceutical company developing locally delivered gene- based medicines, today announced Phase Ib clinical trial data for its lead oncology product candidate, TNFerade. The results were released in a presentation at the American Society of Clinical Oncology Annual Meeting being held this week in Orlando, Florida. The Phase Ib clinical trials of TNFerade were conducted at four centers around the country and involved patients with a wide variety of cancers including cancer of the breast, lung, head and neck, skin, rectum, and pancreas. TNFerade showed substantial activity against all types of tumors tested.
Clinical Observations (21 Patients Evaluable for Activity)
* Fifteen out of twenty-one (15/21) patients (72%) showed objective tumor
shrinkage which means that their tumors shrank between 25% and 100% with
TNFerade therapy. The objective tumor responses are classified as
Complete Response (CR) 3/21 patients, Partial Response (PR) 7/21
patients and Minor Response (MR) 5/21 patients in this study.
* Five out of twenty-one (5/21) showed stable disease (SD).
* Only one out of 21 (1/21) patients showed progressive disease in the
injected lesion; 20/21 (95%) either showed tumor shrinkage or stable
disease in the injected lesion.
* The responses were durable during the follow-up period from 2 to 12
months.
* In patients with at least 3 months follow-up data (cohorts 1-4), 13/15
(87%) of patients showed objective tumor shrinkage (25%-100% reduction
in tumor size).
* Anticancer activity was independent of histology or tumor site (Tumor
shrinkage occurred in all types of cancer tested).
* Three out of four (3/4) patients with pancreatic cancer showed tumor
shrinkage (2 PRs, 1 MRs). One patient who was able to be followed for 12
months still showed no disease progression.
* 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 (26 Patients Evaluable for Safety)
* Drug very well tolerated
* No Dose-Limiting Toxicities (DLT) seen
* No drug-related Serious Adverse Events (SAE) seen
* Serum-TNF levels very low (large safety margin)
* No adenovirus detected in blood or urine of patients
* Side effects were all classified as mild.
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.
"Objective tumor shrinkage of 72% in a Phase I study in solid tumors is very encouraging," stated Dr. Henrik Rasmussen, Senior Vice President for Clinical Research and Regulatory Affairs for GenVec, Inc. Dr. Rasmussen continued, "TNFerade appears to have broad-spectrum activity across a large number of tumor types, including tumor types which do not typically respond well to radiation therapy, such as melanoma, sarcoma and pancreatic cancer. Although this is consistent with the known mechanism of action of TNFerade, it is gratifying to observe this broad-spectrum activity in humans." Dr. Rasmussen continued, "This high level of activity is further encouraging in the context of a favorable toleration profile. The side effects seen have been transient and mild, and based upon measurements of TNF-alpha in plasma, we appear to have a very large therapeutic window as the plasma levels we have observed are approximately 100 to 1,000 fold below toxic plasma concentrations of TNF-alpha. Our challenge now will be to translate the tumor shrinking activity of TNFerade into a meaningful patient benefit by demonstrating improvements in survival and/or quality of life in larger Phase II studies. GenVec is currently developing its Phase II studies in pancreatic cancer and esophageal cancer. The first Phase II clinical trial of TNFerade in patients with locally advanced pancreatic cancer is planned to begin this summer."
Dr. Paul H. Fischer, GenVec's President and Chief Executive Officer commented, "The market for TNFerade is significant. Each year, in the United States alone, over 700,000 people receive radiation therapy as the standard of care for the treatment of cancer. GenVec has several goals with TNFerade; we want to improve standard radiation therapy by increasing its efficacy and reducing its toxicity and we want to provide a safe, therapeutic option for patients with locally advanced cancers and solid tumors. The Phase I data on TNFerade met each of these goals and strongly supports our decision to advance as quickly as possible into broader Phase II studies."
The Phase Ib clinical trials for TNFerade in solid tumors were conducted at the Albert Einstein College of Medicine, Montefiore Medical Center in New York; the University of Kentucky Medical Center, Lexington; US Oncology in Dallas, Texas, and University of South Florida Medical Center, Tampa and include patients who have failed standard treatment and who are scheduled to receive radiation therapy for local tumor control. TNFerade is injected directly into the tumors one or two times per week for up to 6 weeks, while patients are receiving their standard radiation therapy. Five dose levels were tested with 3-6 patients at each dose level.
Cancer is the second leading cause of death in the United States; approximately 1.2 million new cases are diagnosed in the United States each year, responsible for more than 500,000 deaths per year.
GenVec is a publicly held biotechnology company focused on the development and commercialization of gene-based therapies that produce medically beneficial proteins at the site of disease. The Company combines its patented gene transfer technologies with proprietary therapeutic genes to create product candidates, such as BioBypass angiogen for cardiovascular disease, TNFerade for solid tumors and AdPEDF for macular degeneration and diabetic macular edema. Additional information on GenVec is available at its web site located at genvec.com , and in the Company's various filings with the Securities and Exchange Commission. |
