AEterna Zentaris (AEZS) reported Phase 3 results for its North American efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia (BPH), with its lead endocrinology compound for urology, cetrorelix pamoate.
The first multi-center efficacy trial Z-033 was conducted in 53 sites in the United States and Canada, with 8 additional sites in Europe. The study involved 667 patients under the supervision of lead investigator, Herbert Lepor, M.D., Professor and Chairman, Department of Urology, at NYU School of Medicine, New York. Patients entered a 1- to 4-week screening period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS). Read more
AEterna Zentaris Partner Keryx Reports Positive Phase 2 Data for Perifosine (KRX-0401) in the Treatment of Advanced Metastatic Colon Cancer (AEZS , KERX)
Keryx Biopharmaceuticals, Inc (Nasdaq: KERX) a partner of AEterna Zentaris (Nasdaq: AEZS) has announced positive results in its phase II trial of its advanced metastatic colon cancer drug, Perifosine.
Perifosine (KRX-0401) is the company’s Akt-inhibitor for cancer that is used in combination with capecitabine as a treatment for advanced colon cancer. This news was announced during the Colorectal session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Orlando, Florida.
In this randomized, double-blind, placebo-controlled study conducted at 11 centers across the United States, patients with 2nd or 3rd line metastatic colon cancer were randomized to receive capecitabine (Xeloda®), an approved drug for metastatic colon cancer, plus either perifosine or placebo. Treatment was continued until progression. The study enrolled a total of 38 patients, of which 35 patients were evaluable for response (20 patients on the capecitabine + perifosine arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for response were all in the capecitabine + placebo arm; 2 patients were not evaluable due to toxicity (days 14, 46) and 1 patient was not evaluable due to a new malignancy on day 6.
Perifosine combined with capecitabine was found to more than double the time to progression versus placebo with a statistically significant p-value of 0.0006. In addition, the perifosine treatment doubled the overall response rate and the clinical benefit rate.
Ron Bentsur, Chief Executive Officer of Keryx, commented, “Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine and capecitabine, two oral agents, appears to demonstrate superior clinical benefit over capecitabine alone in this advanced patient population. We will now explore plans to move this program forward in patients with advanced colorectal cancer.”
According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed in the United States. It is estimated that 106,100 people will be diagnosed with colon cancer, 40,870 people will be diagnosed with rectal cancer, and approximately 50,000 deaths will be attributable to some form of colorectal cancer in 2009.
Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)
We have already seen a massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, which is scheduled to start this weekend. ASCO is usually thought of as the Holy Grail of cancer conferences and these abstracts and presentations are viewed by investors, analysts, clinicians, doctors, and by cancer patients.
We compiled a brief synopsis for the following drug and biotech companies: Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).
Be advised that some of the data may have been changed since the first abstracts came out, but this is an expansive list of companies with data.