Introgen Therapeutics' products Advexin and INGN 241 have been reviewed and it is reported that successes in clinical trials have been achieved with Advexin and describes phase 1 studies with INGN 241 as promising. Advevin is Introgen's p53 gene based cancer therapeutic being evaluated in two phase 3 studies, 5 phase 2 clinical studies, and numerous phase 1 studies totaling studies in ten cancers. INGN 241, an mda-7 gene based cancer therapeutic, is being evaluated in phase 1 and phase 2 trials for various solid tumors. Both products are covered by multiple issued and pending patents controlled by Introgen.

INGN 241 has exhibited supra-additive or synergistic activity with existing cancer treatments such as chemotherapy and radiotherapy in preclinical studies. Preclinical studies demonstrated that INGN 241 kills a broad spectrum of cancer cells, yet has minimal toxicity to normal cells. Induction of apoptosis (programmed cell death) appears to be selective for tumor cells. Mda-7 is a multi-functional gene, exhibiting both tumor suppressor and immune-system stimulating properties. INGN 241 has an unusual combination of attributes; it can directly cause cancer cells to die and then the MDA-7 protein released from tumor cells can stimulate the immune system to attack additional metastatic tumor cells. This two-pronged approach to killing cancer cells may provide real benefit to patients with advanced cancers. A discussion of the cancer fighting potential of mda-7 in the article asks "mda-7 -- is there finally a magic bullet for cancer?" and concludes that "mda-7 kills a wide range of diverse cancers, almost without exception, while not inducing harmful effects in normal cells or tissues."

The mda-7 gene was discovered by the laboratory of Dr. Paul B. Fisher, co- author of the article and professor of clinical pathology and the Michael and Stella Chernow Urological Cancer Research Scientist in the Departments of Neurological Surgery, Pathology and Urology at Columbia University. Introgen holds an exclusive worldwide license for all gene therapy applications from the Corixa Corporation.

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. The article notes, "Based on the prevalence of mutations in p53 in diverse human cancers, p53 gene replacement as a cancer therapeutic has received great interest," and, "All previous clinical trials have demonstrated safety, clinical feasibility and lack of adverse effects in normal tissue." 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. Two phase 3 studies designed to obtain marketing approval are evaluating Advexin in the treatment of recurrent and refractory head and neck cancer. Additionally, a phase 2 clinical study is ongoing at The University of Texas M. D. Anderson Cancer Center that is evaluating 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.