The BLUE HP has been educational if not a money maker . . .
>>AUSTIN, Texas, July 2 /PRNewswire-FirstCall/ -- A late-stage lung cancer patient treated with ADVEXIN® adenoviral p53 gene drug therapy has survived for sixty-three months, Introgen Therapeutics Inc. (Nasdaq: INGN - News) announced today. Typically, the midpoint of known survival time is six months for end- stage lung cancer patients who, like her, have failed conventional treatments such as surgery or chemotherapy. The patient experienced no significant side effects during treatment.
She received ADVEXIN in 1997 as part of a phase 1 trial at The University of Texas M. D. Anderson Cancer Center in Houston after being diagnosed with metastatic non-small cell lung cancer. The patient's tumor could not be surgically removed because the cancer had spread within the lungs, and multiple courses of chemotherapy had failed to stop the tumor's growth.
"The fifth year anniversary of this lung cancer patient's survival suggests the exciting potential of ADVEXIN as a cancer drug," said James A. Merritt, M.D., Introgen's chief medical officer. "Introgen maintains a vigorous clinical trials program to evaluate ADVEXIN as a drug treatment for a range of cancers, including two phase 3 studies designed to obtain marketing approval from the FDA and other regulatory agencies."
ADVEXIN is a drug whose active ingredient is the p53 tumor suppressor gene, which kills cancer cells or stops tumor growth via an adenoviral delivery system without harming normal cells. When ADVEXIN is administered to patients, large quantities of the non-toxic p53 gene overwhelm cancer cells and then are quickly cleared from the body. ADVEXIN is extremely well tolerated, with only minimal side effects demonstrated in 20 clinical studies involving eight different cancer types.
The two phase 3 studies designed to obtain marketing approval -- currently enrolling patients in North America, Western and Eastern Europe -- are evaluating ADVEXIN in the treatment of recurrent and refractory head and neck cancer.
Introgen also recently began enrolling breast cancer patients in a new phase 2 clinical study at The University of Texas M. D. Anderson Cancer Center that will evaluate ADVEXIN as a treatment for women with advanced breast cancer in combination with two chemotherapy drugs.
Additionally, Introgen has completed multiple phase 2 studies that have demonstrated ADVEXIN's safety and clinical activity, and the ongoing clinical development program includes 20 clinical studies testing ADVEXIN alone and in combination with other treatments for a variety of cancers including lung, head and neck, breast, prostate, brain, bladder and other cancers.
Clinical Trial Information
Anyone interested in participating in a clinical trial evaluating ADVEXIN in the treatment of head and neck cancer, or other cancers, if in the United States, call 866-631-4646 or email clinicaltrials@introgen.com . Anyone outside the United States should call 713-610-4099.
Introgen has developed Good Manufacturing Practices (GMP) compliant production capabilities and expertise via the production of the worldwide phase 2 and 3 requirements of ADVEXIN over the past five years. Based on this expertise, the company was awarded the production contract for the adenoviral reference material by the Williamsburg BioProcessing Foundation, acting as facilitator for the Adenoviral Reference Material Working Group. Academia, industry and worldwide regulatory bodies will use this reference standard as a standard for the development of adenoviral gene therapy products. The Office of Cellular and Gene Therapies of the U.S. Food and Drug Administration advised on the award. In addition, Introgen currently has agreements for manufacturing and process development in place with select third parties.
Introgen is a leader in the development and production of gene-based drugs for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, cGMP manufacturing facility. Through more than 20 clinical trials, the company has treated hundreds of patients with thousands of doses of its lead product candidate, ADVEXIN® adenoviral p53 therapy. Introgen is conducting two controlled, randomized phase 3 clinical trials with ADVEXIN for the treatment of head and neck cancer, a phase 2 study in breast cancer, as well as phase 1 trials in prostate, ovarian, bladder, and brain cancers, and completed phase 2 studies in lung and head and neck cancers.<<
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Cheers, Tuck |
