A bad sports analogy but appropriate for these two stories. One is specific to PC and is likely to gain FDA approval and reach the market in the next 12-18 months. The second is longer term in nature and currently being tested only on laboratory mice.
Dendreon Announces New Data Analyses Presented at Prostate Cancer Foundation Scientific Retreat
PROVENGE Significantly Extends Prostate Cancer Specific Survival in Advanced Prostate Cancer
SEATTLE, WA, October 20, 2006 – Dendreon Corporation (Nasdaq: DNDN) today announced that Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco presented new exploratory analyses of the Phase 3 Study (D9901) that further support the results observed with the Company's investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with advanced androgen-independent (hormone refractory) prostate cancer.
These data were presented at the Prostate Cancer Foundation's 13th Annual Scientific Retreat held Oct. 19-21, 2006 in Scottsdale, Arizona. The Company plans to complete the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) prior to the end of this year to seek approval to market PROVENGE.
The analyses presented by Dr. Small showed:
The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and
An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).
A link to Dr. Small's slide show presentation is available via Dendreon's web site at http://investor.dendreon.com/medialist.cfm
"These and other analyses we have performed further support our BLA filing, which we intend to complete this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We remain focused on the goal of making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer who currently have few appealing treatment options available to them."
About PROVENGE (sipuleucel-T)
PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95 percent of prostate cancers. PROVENGE is in late-stage development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
Scientists Say Cancer-Killing Virus Developed
Agence France-Presse | 10.19.2006
SEOUL —South Korean scientists have said they have developed a new genetically altered strain of virus which is highly efficient in targeting and killing cancer cells.
The new therapy developed by the team from Yonsei University uses a genetically-engineered form of the adenovirus, which normally causes colds.
The adenovirus was implanted with a human gene that is related to the production of relaxin, a hormone associated with pregnancy.
When injected into cancerous tumors, the virus quickly multiplies in the cancer cells and kills them, the team said.
The new adenovirus can target only cancer cells and does not harm normal cells, the team said.
Existing viral treatments fail to kill off all the cancerous cells.
“I believe we have found a way to overcome one of the great obstacles to finding a genetically altered viral cure for cancer,” Yun Chae-Ok, one of the researchers, told AFP on Thursday.
Following three rounds of injections, more than 90 percent of cancer cells in the brains, liver, lungs and womb of mice disappeared within 60 days, the team said.
Clinical tests will be carried out early next year and last 18 months, Yun said.
The research results were published in the October 18 edition of the prestigious bimonthly Journal of the National Cancer Institute in the United States.
Copyright 2006 Agence France-Presse