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Published on 11/8/2005 in the Prospect News Biotech Daily.

Introgen says study shows INGN 241 with Celebrex may treat breast cancer

By E. Janene Geiss

Philadelphia, Nov. 8 - Introgen Therapeutics, Inc. reported Tuesday that preclinical data demonstrates that INGN 241 works synergistically with Pfizer's Celebrex to inhibit growth and increase cell death of breast cancer cells.

The data, which appears in the current issue of the medical journal "Surgery," shows the potential utility of INGN 241 in combination with celecoxib, a drug approved for the treatment of precancerous lesions of the colon, and exemplifies the increase in understanding of the effects of INGN 241 on multiple cancer-related pathways, according to a company news release.

Results of the study may help in designing new low-toxicity treatment strategies that combat breast cancer, officials said.

Previous studies have shown that celecoxib (Celebrex) and INGN 241 work as single agents to inhibit growth and increase killing of cultured breast cancer cells. Celecoxib inhibits COX-2, an important enzyme associated with cancer progression that also can regulate the cell survival pathways.

Because related cell survival pathways also are a target of mda-7, the active component of INGN 241, studies were undertaken to evaluate the effects of simultaneously inhibiting these pathways in human breast cancer cells. Results showed that INGN 241, celecoxib and the combination markedly inhibited cell growth compared with controls.

The combination showed greater than additive increases in cell death compared with either therapy alone, and also resulted in the suppression of tumor cell growth. The effectiveness reported in these studies and favorable safety profile of INGN 241 observed to date support additional study of this regimen as a novel breast cancer therapy, official said.

"Combining two low toxicity agents may provide additional options for breast cancer patients," Sunil Chada, Introgen's associate vice president of clinical research, said in the release.

Celecoxib is approved by the Food and Drug Administration for treatment of arthritis and also approved as the first drug therapy for patients with familial adenomatous polyposis, a genetic condition that can lead to colon cancer.

A small subset of patients may have increased risk of cardiovascular side effects when taking COX-2 inhibitors like celecoxib. This small risk may be acceptable for cancer patients with unmet medical needs depending upon the potential benefits of the therapy, officials said.

Austin, Texas-based Introgen is a biopharmaceutical company focused on development of targeted molecular therapies to treat cancer and other diseases.


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