Navigation Links
Tokai Pharmaceuticals' galeterone well-tolerated in patients with advanced prostate cancer
Date:3/31/2012

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
caton@purecommunicationsinc.com
910-232-7166
Pure Communications Inc.
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:5/16/2017)... 16, 2017   Bridge Patient Portal , ... MD EMR Systems , an electronic medical ... GE, have established a partnership to build an ... the GE Centricity™ products, including Centricity Practice Solution ... These new integrations will allow healthcare delivery ...
(Date:4/19/2017)... 19, 2017 The global military ... is marked by the presence of several large global ... by five major players - 3M Cogent, NEC Corporation, ... for nearly 61% of the global military biometric market ... the global military biometrics market boast global presence, which ...
(Date:4/13/2017)... April 13, 2017 UBM,s Advanced Design and ... will feature emerging and evolving technology through its 3D ... will run alongside the expo portion of the event ... and demonstrations focused on trending topics within 3D printing ... and manufacturing event will take place June 13-15, 2017 at ...
Breaking Biology News(10 mins):
(Date:10/12/2017)... ... October 12, 2017 , ... The ... three Winners and six Finalists of the 2017 Blavatnik Regional Awards for Young ... Family Foundation and administered by the New York Academy of Sciences to honor ...
(Date:10/12/2017)... FL (PRWEB) , ... October ... ... (RPS®) today announces publication of a United States multicenter, prospective clinical study ... use, disposable, point-of-care diagnostic test capable of identifying clinically significant acute bacterial ...
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, a global contract ... to improve patient outcomes and quality of life, will now be offering its ... attributed to new regulatory requirements for all new drug products, including the finalization ...
(Date:10/11/2017)... ... 11, 2017 , ... At its national board meeting in ... Sheikh, the co-founder, CEO and chief research scientist of Minnesota-based Advanced Space Technology ... in ARCS Alumni Hall of Fame . ASTER Labs is a technology ...
Breaking Biology Technology: