To: SpinCity1 who wrote (88025 ) 6/2/2003 8:50:36 AM From: JustTradeEm Read Replies (2) | Respond to of 208838 Here's what I could find on DNDN .... has one more presentation today, I believe. Marketwatch: 12:01 ET At the American Society of Clinical Oncology's 2003 annual meeting in Chicago, Dendreon Corp. said results from a Phase I trial of a vaccine candidate indicate it's "well-tolerated, stimulates T-cell immunity and is continuing to show ongoing clinical benefit" in patients with breast cancer. Among 16 patients with an advanced form of the cancer, four demonstrated what Dendreon called "clinical benefit" when treated with APC8024, an investigational therapeutic vaccine designated to treat breast, colon and ovarian cancer. Of these, one patient experienced tumor reduction and the other three saw their breast cancer stabilize for more than 48 weeks, noted Dr. Michelle Melisko of the University of California at San Francisco, co-investigator of the trial with Seattle-based Dendreon. The company plans further testing of APC8024. Dendreon's stock ended Friday's action at $6.29, up 28 cents. Marketwatch: Dendreon Corp. (DNDN) said results from a Phase I trial of a vaccine candidate indicate it's "well-tolerated, stimulates T-cell immunity and is continuing to show ongoing clinical benefit" in patients with breast cancer. Among 16 patients with an advanced form of the cancer, four demonstrated what the biopharmaceutical company called "clinical benefit" when treated with APC8024, an investigational therapeutic vaccine designated to treat breast, colon and ovarian cancer. Dow Jones: CHICAGO (Dow Jones)-A follow-up to earlier Phase III data on Dendreon Corp.'s (DNDN) investigational Provenge cancer vaccine shows that it works by generating an immune response in the patient, confirming the company's expectations. The new data, released Saturday at the American Society of Clinical Oncology's annual meeting here, show that Provenge induced an eight-fold increase in T-cell proliferation compared to a placebo in a trial involving prostate cancer patients. T-lymphocytes, or T-cells, kill antigen-bearing cells, eliminating cancer and virally infected tissue. This follow-up data was critical in order to prove that the vaccine worked as expected, said Dr. Mitchell Gold, CEO of Dendreon. "We're confirming the drug's mechanism of action, and that's no small feat," Gold said. "It's a significant step forward." Late last year, a placebo controlled Phase III trial showed that in addition to delaying the time to progression of disease in prostate cancer patients, Provenge delayed the onset of disease-related pain in patients with hormone resistant prostate cancer with a Gleason score of seven or less. A Gleason score refers to the degree of aggressiveness seen in prostate cancer in different patients. The higher the score, the more aggressive the cancer. In that trial, the placebo group had a median time to disease progression of nine weeks compared to 16 weeks in the Provenge treated group. For patients with a Gleason score of seven or less treated with Provenge, the probability of remaining free of cancer-related pain while on the study was over two and one-half times higher than for patients treated with the placebo. The follow-up data released Saturday involved 127 patients, 75 of whom had Gleason scores of seven or below. T-cell activated immune response was seven-fold greaterin Provenge-treated men with a Gleason score of seven or less than in Provenge-treated men whose tumors got a Gleason score of eight or more, the company said. There's no evidence that the vaccine can be effective for men with scores of eight or higher, Gold said. But the new study does confirm the drug's mechanism of action in patients with less aggressive cancers. "We saw clinical benefit in the first data (last year), but we couldn't figure out why," Gold said. "Now we've found the smoking gun. A key piece of drug development is to confirm that the mechanism of action correlates to the clinical benefit." In other words, the huge increase in T-cell activity seen in the patients treated with Provenge can be directly linked to the positive clinical results seen earlier. To overcome the limitations of the immune system and direct it to fight cancers, Dendreon has developed immunotherapeutic cancer vaccine candidates by identifying and engineering tumor antigens to be recognized by the immune system. Dendreon then uses a technique to isolate and manipulate dendritic cells to stimulate a vigorous T-cell immunity. Dendritic cells act as sentries in the body, picking up antigens, or proteins, from an invader like cancers or germs. Doctors have been working for 10 years on harnessing these cells to make a cancer vaccine. Such a vaccine would kill cancer cells, and would work with fewer side effects than chemotherapy, a standard cancer treatment. -By Daniel Rosenberg, Dow Jones Newswires; 847-630-7892 daniel.rosenberg@dowjones.com (END) Dow Jones Newswires 05-31-03 1635ET