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Preliminary Results Show Potential of Novel Angiogenesis Signaling Inhibitor SU5416 to Inhibit Growth and Spread of Colorectal Cancer.

Encouraging One Year Tolerability Data Presented

In Patients with Colorectal Cancer

NEW ORLEANS, May 23 /PRNewswire/ --

Preliminary results for the novel angiogenesis signaling inhibitor, SU5416, show that when the drug is given to patients with untreated, advanced (known as metastatic) colorectal cancer, it may extend the time patients remain free of tumor growth and spread. Phase I/II data presented today at the annual meeting of the American Society of Clinical Oncology also suggest that SU5416 is well tolerated for at least one year when combined with 5-fluorouracil/leucovorin (5-FU/LV). SU5416 was developed by Sugen, a wholly owned subsidiary of Pharmacia Corporation. Angiogenesis signaling inhibitors, drugs being developed to starve tumors of their blood supply and thus inhibit their growth and spread, may bring new treatment approaches to colorectal and other solid tumors.

"This data is extremely encouraging when evaluating new options for the treatment of advanced colorectal cancer," said Lee Rosen, M.D., Assistant Professor, Director of Cancer Therapy Development Program, UCLA. "With more extensive clinical studies, we hope to define the role of SU5416 in the prevention of the growth and spread of colorectal and other tumors."

The Phase I/II study presented today evaluated 28 patients to determine the safety and tolerability of SU5416 when used in combination with 5-FU/LV. Patients with untreated advanced colorectal cancer were treated with increasing doses of SU5416 (85 mg/m(2) and 145 mg/m(2)) administered intravenously twice each week, in combination with standard doses of 5-FU/LV therapy. In a preliminary analysis of this data, it was shown that patients receiving SU5416 were found to be free of tumor growth and spread for a median time in excess of 9.2 months. Of the 28 patients who participated in the study, data to date show 41 percent had an objective response (either complete or partial response with 50 percent or greater shrinkage of tumor size).

Safety data has shown no dose-limiting toxicity attributable to SU5416, with three patients remaining on therapy for more than one year. Toxicities seen to date are predominantly those known to occur with 5-FU/LV, including severe nausea, vomiting, diarrhea, mucositis and neutropenia.

SU5416 works by inhibiting angiogenesis. In cancer, angiogenesis is the process by which tumors create their own blood supply to provide nutrients and oxygen essential for their growth. Cancerous tumors recruit normal vascular cells from the body to build these blood vessels. SU5416 is novel because it interferes with the communication channels between the tumor and healthy cells in the body. SU5416 does this by blocking a protein called the vascular endothelial growth factor receptor (VEGF-R). By blocking the VEGF-R, SU5416 could block the ability of tumors to form blood vessels, thus depriving the tumor of necessary nutrients. Scientists hope that this process will starve tumors, preventing further tumor growth.

Pharmacia/Sugen is also currently conducting a pilot study to evaluate the safety of SU5416 in combination with CAMPTOSAR(R) (irinotecan hydrochloride injection), Pharmacia Oncology's flagship chemotherapeutic agent, and 5-FU/LV for the treatment of metastatic colorectal cancer. Pharmacia/Sugen is also researching oral forms of SU5416.

"SU5416 and other angiogenesis signaling inhibitors have the potential to take cancer treatment to the next level," said Jeff Buchalter, Group Vice President and Head, Global Oncology Franchise, Pharmacia Corporation. "Our study with CAMPTOSAR and SU5416 in advanced colorectal cancer patients is the first step in evaluating the potential of this new class of therapy, and traditional therapies combined."

Also at this meeting, Pharmacia Oncology presented data for other products in its colorectal cancer franchise. Survival data for CAMPTOSAR -- newly approved by the U.S. Food and Drug Administration (FDA) as a component of first-line chemotherapy and considered the new standard of care for first-line treatment for advanced colorectal cancer -- was presented. Data was also presented at the meeting on celecoxib, a COX-2 inhibitor, currently being investigated to determine its potential to decrease the occurrence of new adenomatous polyps (non-cancerous polyps occurring in the colon that can turn malignant).

Pharmacia Oncology is bringing discovery to life for every person touched by cancer. The current oncology portfolio includes CAMPTOSAR(R) (irinotecan hydrochloride injection), AROMASIN(R) (exemestane tablets); ELLENCE(TM)/ FARMORUBICIN(R) (epirubicin hydrochloride injection); IDAMYCIN(R) (idarubicin hydrochloride injection); and, ZINECARD(R) (dexrazoxane injection). Products in development include signaling inhibitors SU5416 and SU6668 and other compounds for the treatment of patients with cancer occurring in various forms. Celecoxib, a COX-2 specific inhibitor is currently in clinical trials to investigate its role in inhibiting the formation of colorectal cancer cells. CELEBREX(TM) (celecoxib capsules) has been approved to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis (FAP) as an adjunct to usual care (endoscopic surveillance and surgery). Celecoxib is also being investigated across a variety of human tumors.

Pharmacia Corporation (NYSE: PHA) is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new medicines, and an annual investment of more than $2 billion in pharmaceutical research and development.

Certain statements contained in this release, such as statements concerning the Company's anticipated financial results, current and new product performance, currency impact and other non-historical facts are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). Since these statements are based on factors that involve risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such factors include, among others: management's ability to implement the strategic initiatives; the Company's ability to successfully market new and existing products in new and existing domestic and international markets; the success of the Company's research and development activities and the speed with which regulatory authorizations and product roll-outs may be achieved; fluctuations in exchange rates; the effects of the Company's accounting policies and general changes in generally accepted accounting principles; the Company's exposure to product liability and other lawsuits and contingencies related to actual or alleged environmental contamination; domestic and foreign social, legal and political developments, especially those relating to health care reform and product liabilities; general economic and business conditions; the Company's ability to attract and retain current management and other employees of the Company; and other risks and factors detailed in the Company's Securities and Exchange Commission filings, including its Proxy Statement and Form 10-K for the year ended December 31, 1999.
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Publication:PR Newswire
Date:May 23, 2000
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