Adamis Pharmaceuticals (ADMP) files IND with FDA for APC-100 prostate cancer treatment

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REALLY?

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Adamis Pharmaceuticals announces the filings of an IND ("Investigational New Drug") application with the FDA for its APC-100 drug.

According to the announcement, "APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens.

APC-100 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/ therapeutic anti-cancer drugs.

Previously, development of APC-100 has been funded by Michael Milken's Prostate Cancer Foundation (PCF, formerly CapCure), the Department of Defense’s Congressionally Directed Medical Research Programs’ (CDMRP) Prostate Cancer Research Program (PCRP), as well as grants and contracts from the NCI."

The entire transcript can be found here:

http://www.businesswire.com/news/home/20110309005641/en/Adamis-Pharmaceuticals-Files-IND-Product-Candidate-Treat

Excerpt:

APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens. Pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. When tested side by side in the TRAMP prostate cancer mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the marketed Standard of Care giving 55% efficacy. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. Adamis believes these characteristics make APC-100 a first-in-class compound for the potential treatment of castrate-sensitive and castrate-resistant prostate cancer.

Medivation (MDVN) and Astellas Pharma (YPH.BE) to present Follow-Up Data From Phase 1-2 Trial of MDV3100

Via biospace.com ...

SAN FRANCISCO, CA--(Marketwire - February 14, 2011) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that new, long-term, follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer will be presented in a poster session at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in Orlando, Fla. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist.

The abstract (#177), titled "Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: long-term follow-up of the Phase 1-2 study" will be available tomorrow, Tuesday, February 15, at 6:00 p.m. ET on the ASCO website at www.ASCO.org. The full poster (poster board #A71) will be presented on Thursday, February 17, from 4:50 - 6:20 p.m. ET during the General Poster Session B: Prostate Cancer in the Exhibit Hall at the Orlando World Center Marriott. The poster will include the most up-to-date data from this trial and will expand upon the results originally submitted in the abstract.

"We look forward to presenting promising new efficacy data from the Phase 1-2 trial of MDV3100," said Lynn Seely, M.D., chief medical officer of Medivation. "As part of these data, we will be sharing results of median time to prostate specific antigen (PSA) progression. We will be presenting PSA progression data calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2)."

http://www.biospace.com/news_story.aspx?StoryID=210603&full=1