In The News July 1999

Late-breaking, brief news items of interest to life extensionists, as well as anyone interested in living a longer, healthier life.

Pancreatic cancer is the fifth leading cause of cancer mortality in the United States. The American Cancer Society estimates that 29,000 Americans died of the disease in 1998. Conventional medicine's inability to effectively treat pancreatic cancer is evidenced by survival rates of only 18% at one year and 4% at five years-one of the poorest 5-year survival rate of any cancer.

A study appearing in the May 1999 issue of the International Journal of Oncology reported on a group of end-stage pancreatic cancer patients treated with an experimental drug called rubitecan (RFS-2000). The patients had failed all previous conventional therapies and were thus eligible to participate in this clinical trial. Of the 60 patients who were able to complete the therapy, 31.7% responded favorably with a median survival of 18.6 months. Another 31.7% were stabilized with a 9.7 month median survival rate, while 36.6% were non-responders with a 6.8 month median survival rate.

Considering how quickly pancreatic cancer kills (often 3-12 months after diagnosis), this new drug may be considered as a first-line therapy in the treatment of pancreatic and other cancers. The patients in this study had already suffered through useless cytotoxic chemotherapy and were considered to be terminally ill. Pancreatic cancer patients in earlier states of the disease are expected to do far better using rubitecan, especially when adjuvant therapies are incorporated.

The company who makes rubitecan is called SuperGen Inc. of San Ramon, California. On May 11, 1999, the company announced that it has more than doubled the number of cancer centers participating in its Phase III clinical trial of rubitecan (previously known as RFS 2000) .

SuperGen has added 75 clinics operated by Dallas-based Physician Reliance Network (PRN), thus bringing the total number of centers participating in the trial to 132. Current enrollment is 255 patients, and this number is expected to increase rapidly.

Formed in 1993, Dallas-based PRN is the nation's largest oncology-focused physician practice management company. PRN manages the practices of some 340 physicians at 127 locations in 13 states, including 23 full-service cancer centers.

SuperGen expects to expand Phase II clinical trials of rubitecan in the U.S. to include four additional types: liver cancer, melanoma, glioma, and sarcoma. Thus, including recently announced European-based clinical studies of rubitecan in seven solid tumors (colorectal, gastric, lung, breast, prostate, cervical, and head and neck cancers), rubitecan has been expanded to eleven tumor types beyond pancreatic cancer.

Finally, the Company also announced that it has begun a study of rubitecan (RFS 2000) -- combined with gemcitabine -- to treat pancreatic cancer patients. This study is under way at major cancer center in Philadelphia, Pa.

"Rubitecan is the most important drug in our broad pipeline, as well as our most advanced and top-priority clinical project," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "Due to the lack of effective treatment for pancreatic cancer patients, we are taking every step possible to accelerate our Phase III trial in order to be in position to submit a New Drug Application to the FDA as quickly as possible. We are confident that the addition of PRN's clinics will substantially increase enrollment of patients, thus leading to a rapid and successful conclusion of the Phase III study."

"Rubitecan has shown activity against a number of tumors, and we are very pleased to fast-forward our U.S.-based clinical development programs for rubitecan beyond pancreatic cancer," Dr. Rubinfeld added.

A significant advantage of rubitecan is that the drug can be given orally on an outpatient basis, thus providing convenience for patients. This is in contrast to other cancer drugs that have to be given intravenously either in a hospital or physician's office.

Rubitecan has also shown activity in hematologic tumors as well. A clinical study under way at the M.D. Anderson Cancer Center in Houston using rubitecan has shown efficacy in fifty percent of patients suffering from myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML), thus indicating a very broad spectrum of activity encompassing both solid tumors and hematologic malignancies.

"Several advantages distinguish rubitecan as a potential therapy for treating cancer. One advantage is its side-effect profile relative to other anticancer drugs. In studies to date, none of the cardiac, pulmonary, hepatic, neurological or renal toxicities that limit the acute and/or chronic dosages of most chemotherapies have been observed and, in fact, studies suggest that rubitecan could be used to treat cancer on a chronic, rather than acute, basis," said Dr. Rubinfeld. "The side effects are manageable hematological toxicities, cystitis (bladder irritation), and some gastrointestinal disorder -- in all, a relatively benign profile."

Read The Foundation's updated Pancreatic Cancer Treatment Protocol online.

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