To: LLCF who wrote (176 ) 4/22/1999 1:50:00 PM From: Biomaven Read Replies (1) | Respond to of 52153
Nice move by SUPG on publication of some RFS 2000 results. I'm still long for now - in general the cancer stocks I own (except PCYC) have been pretty strong the last few weeks in an overall weak market for biotechs. Here's the release. Note that the % response is somewhat exaggerated, because only 60 of 107 were viewed as "evaluable." Pancreatic Cancer Breakthrough Reported in Current Issue of International Journal of Oncology PR Newswire - April 22, 1999 12:46 SuperGen's oral anticancer medication "is safe and efficacious as first-line therapy for the treatment of advanced pancreatic cancer." John S. Stehlin, M.D., Surgical Oncologist Director, Stehlin Foundation for Cancer Research SAN RAMON, Calif., Apr. 22 /PRNewswire/ -- SuperGen's (Nasdaq: SUPG) licensor, the renowned Stehlin Foundation for Cancer Research, announced today that results from a Phase II study of oral 9-nitrocamptothecin ("9NC"), also known as "RFS 2000", SuperGen's proprietary drug for the treatment of advanced pancreatic cancer, have been published in the peer-reviewed International Journal of Oncology. The Phase II study, conducted at St. Joseph Hospital in Houston, evaluated the efficacy of RFS 2000 in the treatment of patients with advanced pancreatic cancer. A total of 107 patients were enrolled in the study, of which 60 completed the minimal effective two month treatment period and thus are evaluable. RFS 2000 either shrank the pancreatic tumor or stabilized the disease in 63 percent of patients with advanced disease. Among the 60 evaluable patients, 31.7 percent (19/60) were responders, 31.7 percent (19/60) were stable, and 36.6 percent (22/60) were non-responders following treatment with RFS 2000. Median survival time among "responders" was 18.6 months, which is the longest survival time ever reported among advanced pancreatic cancer patients. "RFS 2000 is the most hopeful development I have seen in more than three decades of fighting cancer," said John S. Stehlin, M.D., the study's lead author and surgical oncologist who founded the Houston-based Stehlin Foundation for Cancer Research in 1969. "These data suggest that RFS 2000 (9NC) is safe and efficacious as first- line therapy for the treatment of advanced pancreatic cancer. It is very important to note that the patient population in our study is quite representative of the types of patients seen in clinical practice," Dr. Stehlin explained. "The criteria for enrollment were liberal, which allowed patients with very advanced disease to participate in our clinical trial. Furthermore, we did not limit the patient population to previously untreated individuals. It is well known that patients who have had prior treatment generally do not respond as well as previously untreated patients. Nearly half of our study's patients had undergone prior treatment, including gemcitabine. "In addition to its safety and efficacy, RFS 2000's oral delivery method also is advantageous for patients," Dr. Stehlin continued. "Most anticancer drugs are administered intravenously, which can represent a considerable inconvenience to the patient. The necessity of traveling to a physician's office or medical facility for therapy considerably increases the cost of treatment. As an oral anticancer medication, RFS 2000 provides a convenient method for treating pancreatic cancer, as it is given orally on an outpatient basis which should ultimately translate to a more convenient form of administering anticancer therapy," Dr. Stehlin concluded. According to the American Cancer Society, cancer of the pancreas killed nearly 29,000 persons last year. Pancreatic cancer has the poorest five-year survival rate of any cancer; indeed, even with the most aggressive treatment available (chemotherapy, radiation and surgery), the average survival time following diagnosis for advanced disease is just four to five months. In January, SuperGen Inc. announced that it has significantly expanded its Phase III studies of RFS 2000. The Phase III program is comprised primarily of two studies. The first compares RFS 2000 to Gemzar(R) in patients who have not had prior chemotherapy. Gemcitabine (Gemzar(R), Eli Lilly & Company), was approved by the FDA in 1997 to treat pancreatic cancer. Analysts expect Gemzar to realize about $500 million in sales in 1999 -- even though Gemzar has little impact on shrinking the cancer. The second study compares RFS 2000 in patients who have previously been treated with and failed gemcitabine to 5- FU, a drug that has been the traditional treatment against pancreatic cancer. <snip> Peter ....