Navigation Links
Tokai Pharmaceuticals' galeterone well-tolerated in patients with advanced prostate cancer

CAMBRIDGE, Mass. and CHICAGO, Ill. -- Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate galeterone (TOK-001) was well-tolerated with minimal side effects and demonstrated efficacy in patients with castration-resistant prostate cancer (CRPC) in a Phase 1 study. The data will be presented in an oral presentation titled, "ARMOR1: Safety of galeterone (TOK-001) in a Phase 1 clinical trial in chemotherapy nave patients with castration-resistant prostate cancer (CRPC)," abstract number CT-07, on Tuesday, April 3, 2012 at 3:05 p.m. (CDT) at the American Association for Cancer Research (AACR) Annual Meeting 2012 in Chicago.

CRPC is an advanced, difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of anti-hormonal therapies. Galeterone is a small molecule, oral drug for the treatment of CRPC that disrupts the growth and survival of prostate cancer cells via a novel and proprietary triple mechanism of action.

"Because currently available therapeutic options to treat castration-resistant prostate cancer are limited, often poorly-tolerated and may fail because of resistance, patients are in urgent need of new safe and effective treatments," said Mary-Ellen Taplin, M.D., associate professor of medicine, director of genitourinary clinical research, Dana-Farber Cancer Institute, Harvard Medical School and co-lead researcher in the study. "These Phase 1 galeterone data, demonstrating minimal toxicities, improved PSA response and a reduction in tumor size, are exciting for those of us in the medical community treating this life-threatening cancer. I look forward to following the further development of galeterone as a promising approach in the treatment of prostate cancer."

The ARMOR1 study was led by co-principal investigators Dr. Taplin and Bruce Montgomery, M.D., associate professor of medical oncology at the University of Washington School of Medicine, and their colleagues at leading prostate cancer research centers in the United States. The Phase 1 proof-of-concept clinical trial, part of the ARMOR (Androgen Receptor Modulation Optimized for Response) clinical development program for the evaluation of galeterone, enrolled 49 patients and was a dose-finding study to evaluate escalating dose levels of galeterone. The study also evaluated safety and reduction in prostate-specific antigen (PSA) levels from baseline levels measured at first visit. Patients who responded to therapy had the option to continue treatment with galeterone in an extension arm of the trial.

Most side effects were minor and included fatigue, nausea and diarrhea. Early efficacy tests demonstrated that 49 percent of patients had prostate-specific antigen (PSA) reductions of 30 percent or more; 11 of these patients had reductions of 50 percent or more. In addition, CT scans revealed a significant reduction in tumor size for some patients.

"We are pleased with the results of our Phase 1 proof-of-concept study, which demonstrated galeterone tolerability and efficacy in a difficult-to-treat, resistant prostate cancer patient population," said Martin D. Williams, president and chief executive officer, Tokai Pharmaceuticals. "Galeterone is the only prostate cancer therapy in development that combines three distinct mechanisms of action in one compound for a unique multi-target approach. The reductions in PSA levels seen in nearly half of all patients evaluated in our Phase 1 study are meaningful in a dose-escalation study and supportive of our Phase 2 clinical trial set to initiate later this year."

In the Phase 1 study, researchers observed transient, non-serious elevated liver function tests in 15 patients, most of whom were asymptomatic. Eleven of these patients stopped galeterone treatment, and of those, six of seven patients were rechallenged and successfully returned to treatment with no significant recurrence in liver function test elevations.

A Phase 2 study evaluating long-term safety and efficacy of galeterone in CRPC patients is planned for the second half of 2012.

Contact: Caton Lovett
Pure Communications Inc.

Related biology news :

1. From scourge to saint: E. coli bacteria becomes a factory - to make cheaper, faster pharmaceuticals
2. 2012 Biotechnology and Pharmaceuticals: Forthcoming Conferences and Exhibitions
3. Study finds an increase of children accidentally poisoned with pharmaceuticals
4. Study Shows Sutro Biopharmas Biochemical Protein Synthesis Technology Enables Rapid Production and Scale-Up of Biopharmaceuticals
5. PharmaEngine, Inc. and Merrimack Pharmaceuticals, Inc. Enter into a Licensing and Collaboration Agreement on PEP02 (MM-398), Nanoliposomal Irinotecan
6. Environmental risk assessment of pharmaceuticals inadequate
7. Brown licenses potential muscular dystrophy treatment to Tivorsan Pharmaceuticals
8. CoLucid Pharmaceuticals, Inc. announces study data documenting oral efficacy of lasmiditan (COL-144), a selective 5-HT1F receptor agonist, in the treatment of acute migraine attacks
9. Biostar Pharmaceuticals, Inc. Receives New Advertising Approval from Shaanxi SFDA for Marketing Xin Aoxing Capsule
10. NIH awards $8.5 million for research on pharmaceuticals for children
11. TAXIS Pharmaceuticals licenses novel antimicrobial technology from Rutgers and UMDNJ
Post Your Comments:
(Date:10/29/2015)... , Oct. 29, 2015   MedNet Solutions , ... entire spectrum of clinical research, is pleased to announce ... Tech Association (MHTA) as one of only three finalists ... "Software – Small and Growing" category. The Tekne Awards honor ... have shown superior technology innovation and leadership. ...
(Date:10/29/2015)... Oct. 29, 2015  Rubicon Genomics, Inc., today ... distribution of its DNA library preparation products, including ... new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has been ... of NGS libraries for liquid biopsies--the analysis of ... prognostic applications in cancer and other conditions. Eurofins ...
(Date:10/29/2015)... Oct. 29, 2015 Today, LifeBEAM ... partnership with 2XU, a global leader in technical ... smart hat with advanced bio-sensing technology. The hat ... to monitor key biometrics to improve overall training ... the two companies will bring together the most advanced ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf ... the 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section ... her work with turfgrass. , Clarke, of Iselin, N.J., is an extension ...
(Date:11/24/2015)... ... 2015 , ... Copper is an essential micronutrient that all ... copper is also toxic to cells. With a $1.3 million award from the ... a systematic study of copper in the bacteria Pseudomonas aeruginosa (P. aeruginosa), a ...
(Date:11/24/2015)... 24, 2015 --> ... report "Oligonucleotide Synthesis Market by Product & Services (Primer, ... Diagnostic, DNA, RNAi), End-User (Research, Pharmaceutical & Biotech, Diagnostic ... the market is expected to reach USD 1,918.6 Million ... a CAGR of 10.1% during the forecast period. ...
(Date:11/24/2015)... New York , November 24, 2015 ... to a recent market research report released by Transparency ... projected to expand at a CAGR of 17.5% during ... "Non-invasive Prenatal Testing Market - Global Industry Analysis, Size, ... estimates the global non-invasive prenatal testing market to reach ...
Breaking Biology Technology: