Tokai Pharmaceuticals, Inc. (TKAI)

Oncology Corporate Profile

Stock Performance


HQ Location

One Broadway, 14th floor
Cambridge, MA 2142

Company Description

Tokai Pharmaceuticals is a biopharmaceutical company previously focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases. The ARMOR2 and ARMOR3-SV clinical trials of Tokai’s drug candidate, galeterone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) have been closed, with only patients in ARMOR2 long-term extension continuing treatment at this time. Plans remain in effect to present data from the ARMOR3-SV trial in a scientific forum once fully available and analyzed. Assessment of plans for galeterone, the ARDA platform and Tokai’s AR-V7 assay work are underway at this time.


This company does not have any commercial products
  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
galeteroneandrogen receptor antagonistCastrate-resistant Prostate cancer (CRPC)III

View additional information on product candidates here »


Recent News Headlines

Tokai Pharma Shutters Prostate Cancer Drug Trial Early, Shares Crumble

7/26/2016 02:15 pm

(Xconomy Boston) July 26, 2016 - Tokai Pharmaceuticals has been trying to play catch-up for years in the fast-moving field of prostate cancer treatments. But that plan just took a major hit this morning.

Understanding How Cancer Spreads, and How It May Be Stopped

4/11/2016 11:01 am

(Medscape Medical News) Apr 8, 2016 - The latest findings on how cancer cells metastasize from primary to distant sites are highlighted in a special issue of Science, published on April 8.

Tokai Announces Dosing of First Patient in Phase 2 Expansion Study of Galeterone in Enzalutamide-Refractory mCRPC Patients

3/30/2016 04:57 pm

(TheStreet) Mar 30, 2016 - Tokai Pharmaceuticals Inc. today announced that it has begun dosing patients in an expansion arm of ARMOR2, the company’s ongoing Phase 2 clinical trial of galeterone, to further explore the safety and clinical activity of galeterone in metastatic castration-resistant prostate cancer (mCRPC) patients whose disease progressed during treatment with Xtandi® (enzalutamide).

A Zika Breakthrough: Scientists Detail How Virus Can Attack Fetal Brain

3/4/2016 12:03 pm

(Washington Post/To Your Health) Mar 4, 2016 - A team of U.S. researchers announced Friday that they believe they have discovered a mechanism for how the Zika virus can cause the rare birth defect known as microcephaly, in which babies are born with abnormally small heads and underdeveloped brains.

Study Finds Significant Cognitive Impairment In Adult Survivors Of Childhood Brain Tumors

2/2/2016 12:00 pm

(St. Jude) Feb 1, 2016 - The most comprehensive study of its kind concluded that decades after treatment, brain cancer survivors show deficits in cognition, education and employment.

Tokai Announces Update on ARMOR3-SV and Expanded Galeterone Clinical Development Program

1/7/2016 05:45 pm

(Tokai) Jan 7, 2016 - Tokai Pharmaceuticals Inc. today provided an update on its clinical development program evaluating galeterone in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

'Cancer Vaccine' Startup Gritstone Ascends With $100M Round

10/20/2015 11:05 am

(San Francisco Business Times) Oct 20, 2015 - An East Bay biotech startup will use a $102 million venture capital investment to anchor its climb toward cancer's latest, greatest summit.

Japan Acknowledges Possible Radiation Casualty At Fukushima Nuclear Plant

10/20/2015 11:05 am

(Reuters) Oct 20, 2015 - Japan on Tuesday acknowledged the first possible casualty from radiation at the wrecked Fukushima nuclear power plant, a worker who was diagnosed with cancer after the crisis broke out in 2011.

Roswell Park Acquires Niagara Falls Oncology Practice

10/20/2015 11:05 am

(Buffalo News) Oct 19, 2015 - Roswell Park Cancer Institute has acquired Cancer Care & Hematology of Niagara, the Niagara Falls-based oncology practice of Dr. Mohamed S. Ahmed.

Lancet Oncology Commission Calls for Expanding Global Access to Radiotherapy

10/20/2015 11:03 am

(MarketWatch) Oct 20, 2015 - Increasing access to radiotherapy worldwide through greater investment could save millions of lives, according to The Lancet Oncology Commission's report presented yesterday at the 2015 annual meeting of the American Society for Radiation Oncology (ASTRO).

Susan G. Komen®: Women Should Have Access to, Coverage for, Mammography

10/20/2015 11:03 am

(Susan G. Komen®) Oct 20, 2015 - The Susan G. Komen® breast cancer organization today said that all women should have access to regular mammograms when they and their health care providers decide that it is the right time for screening based on individual risk for breast cancer, and that the screening tests should be covered by third-party payers such as insurance companies and government programs.

Kite Pharma Announces Exclusive License with the National Institutes of Health for T Cell Receptor (TCR)-Based Products to Treat Tumors Expressing MAGE

10/20/2015 11:03 am

(Kite) Oct 20, 2015 - Kite Pharma, Inc. today announced that the Company has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T Cell Receptor (TCR)-based product candidates directed against MAGE A3 and A3/A6 antigens for the treatment of tumors expressing MAGE, which include lung, pancreatic, gastric, and breast cancers, among others.

Atara Bio Receives FDA Orphan Drug Designation for STM 434, Atara Bio's Activin Inhibitor for Ovarian Cancer

10/20/2015 11:03 am

(CNN Money) Oct 20, 2015 - Atara Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) granted orphan drug designation for the Company's activin inhibitor, STM 434, for ovarian cancer.

Image-Guided Intensity Modulated Radiation Therapy (Ig-Imrt) Reduces Bowel Side Effects In Cervical Cancer Patients

10/20/2015 11:02 am

(ASTRO) Oct 19, 2015 - For cervical cancer patients undergoing postsurgical radiation therapy, image-guided intensity-modulated radiation therapy (IG-IMRT) resulted in a 14 percent reduction in moderate-to-severe bowel side effects when compared to conventional three-dimensional conformal radiation therapy (3-D CRT), according to research presented today at the American Society for Radiation Oncology’s (ASTRO’s) 57th Annual Meeting.

Frequent Post-Treatment Follow-Up By Advance Practice Nurses Improves Care For High-Risk Head And Neck Cancer Patients

10/20/2015 11:02 am

(ASTRO) Oct 19, 2015 - For high-risk patients who receive chemoradiation therapy for head and neck cancer, frequent follow-up appointments conducted by advance practice nurses (APN) in a clinical outpatient setting allowed for more intensive symptom management, resulting in fewer post-treatment emergency room visits and hospital admissions compared to historical outcomes, according to research presented today at the American Society for Radiation Oncology’s (ASTRO’s) 57th Annual Meeting.

Do Men's Health Supplements Help Prostate Cancer Patients?

10/20/2015 11:02 am

(CBS News/HealthDay News) Oct 19, 2015 - A new study finds no evidence that men's health supplements help prostate cancer patients.

Aggressive Approach to Anaplastic Thyroid Cancer Shows Benefit

10/20/2015 11:02 am

(Medscape Medical News) Oct 20, 2015 - Survival rates of the rare anaplastic thyroid carcinoma, which has a very poor prognosis, show significant improvement when patients are treated with an aggressive combined-modality therapy, although the toxicities associated with such therapies can take their toll, according to research describing experience with the approach at the Mayo Clinic, in Rochester, Minnesota.

IVF Women Third More Likely To Develop Ovarian Cancer

10/20/2015 11:02 am

(The Telegraph [UK]) Oct 20, 2015 - British health experts said the new findings were serious enough to consider screening IVF patients at regular intervals.

San Diego Scientists Discover How To Pit Leukemia Cells Against Each Other

10/20/2015 11:02 am

(KPBS/City News Service [San Diego, CA]) Oct 19, 2015 - The Scripps Research Institute in La Jolla announced today a discovery of antibodies that can turn leukemia cells against each other, a development that could lead to new cancer therapies.

The Connection Between Cancer Treatment and Cardiac Problems

10/20/2015 11:02 am

(U.S. News & World Report) Oct 20, 2015 - As more people survive cancer, doctors are discovering the long-term side-effects of their treatments.

Cold Genesys Announces FDA Acceptance of a Phase I/II Clinical Trial Using CG0070 Plus an Anti-CTLA-4 Checkpoint Inhibitor as a Neo-Adjuvant Immunotherapy for Muscle Invasive Bladder Cancer

10/20/2015 11:02 am

(Yahoo! Finance) Oct 20, 2015 - Cold Genesys, Inc., a late-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration (FDA) accepted a Phase I/II Clinical Trial (NAOMI) using CG0070 plus an anti-CTLA-4 checkpoint inhibitor as a neo-adjuvant immunotherapy for muscle invasive bladder cancer, or MIBC.

Tokai Pharmaceuticals Announces Initiation of Phase 3 ARMOR3-SV Trial of Galeterone in AR-V7 Positive Metastatic Castration-Resistant Prostate Cancer

6/24/2015 04:40 pm

(MarketWatch) June 24, 2015 - ARMOR3-SV represents the first precision medicine-based pivotal clinical trial in prostate cancer; topline data expected by the end of 2016; AR-V7 clinical trial assay components finalized.

Call for Nominations: 2016 ASCO Election

6/9/2015 12:01 pm

(ASCO in Action) June 8, 2015 - Do you know someone who would make a good ASCO President, Board or Nominating Committee member? If so, please consider nominating that person for the 2016 ASCO Election. Self-nominations are welcome.

Merck’s Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will be Stopped Early

3/24/2015 09:01 am

(Merck) Mar 24, 2015 - KEYTRUDA demonstrated superior overall survival and progression-free survival compared to ipilimumab.

Tokai Pharmaceuticals Provides Companion Diagnostic Update

1/12/2015 06:15 pm

(StreetInsider) Jan 12, 2015 - Tokai Pharmaceuticals, Inc., today announced that it has entered into an agreement with the Johns Hopkins University related to the development of a companion diagnostic to determine the AR-V7 status of patients with castration-resistant prostate cancer (CRPC) for use with the Company’s lead product, galeterone, which is in development for the treatment of AR-V7 positive metastatic CRPC.

Tokai Pharmaceuticals Presents Updated Phase 2 Data on Galeterone in Patients with Advanced Prostate Cancer at ESMO 2014

9/29/2014 07:16 pm

(Yahoo! Finance) Sept 29, 2014 - ARMOR2 trial data continue to demonstrate meaningful PSA responses in CRPC.

Tokai Bags $97M For Prostate Cancer Drug in Upsized IPO

9/18/2014 05:06 pm

(Xconomy Boston) Sept 17, 2014 - Tokai Pharmaceuticals may be trying to break into an increasingly crowded field of prostate cancer drugs, but Wall Street investors clearly like its chances to make an impact.

Tokai, Chasing the Field in Prostate Cancer, Files For IPO

8/12/2014 05:05 pm

(Xconomy Boston) Aug 12, 2014 - Tokai Pharmaceuticals has been chasing after the big players in the prostate cancer field with the idea of combining some of the best features of their drugs into a single pill. Now, with that lead drug candidate, galeterone, on the precipice of a late-stage trial, it’s taking that pitch to Wall Street.

Affymetrix Announces Recipients of Its 2014 Tumor Profiling Grant Award to Support Translational Cancer Research

6/18/2014 06:03 am

(Affymetrix) June 18, 2014 - Affymetrix announces the three recipients who have been awarded its 2014 Affymetrix Tumor Profiling Grant.

Tokai Pharmaceuticals Presents New Clinical Data for Galeterone among Patients with Advanced Prostate Cancer at ASCO 2014

6/2/2014 11:37 pm

(Tokai) June 2, 2014 - Tokai Pharmaceuticals, Inc. today announced positive interim results from the Phase 2 ARMOR2 study of galeterone (TOK-001) among patients with castration-resistant prostate cancer (CRPC).

Tokai Pharmaceuticals Appoints Karen J. Ferrante, M.D. as Head of R&D and Chief Medical Officer

4/15/2014 05:02 pm

(Tokai Pharmaceuticals) Apr 15, 2014 - Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer and other hormonally driven diseases, today announced the appointment of Karen J. Ferrante, M.D. as head of R&D and chief medical officer.

Tokai Pharmaceuticals’ Reformulated Galeterone Demonstrates Robust PSA Reductions in Advanced Prostate Cancer Patients

1/29/2014 05:24 pm

(Yahoo! Finance) Jan 29, 2014 - Interim results from ARMOR2 Phase 2 study presented at 2014 ASCO GU Symposium.

Resistance Is Futile

11/6/2013 12:00 pm

(MIT News) Oct 31, 2013 - A new study from MIT and the University of Toronto offers a possible way to overcome resistance to a chemotherapy drug given to more than half of all cancer patients.

Hospitals Prescribe Big Data to Track Doctors at Work

7/12/2013 10:02 am

(Wall Street Journal) July 11, 2013 - Hospitals around the U.S. are trying to change how doctors practice by using data to monitor their progress toward goals.

Blood Test May Detect Colon Cancer, Early Research Suggests

6/7/2013 10:00 am

(NBC News Vitals blog) June 7, 2013 - New research indicates many people may one day be able to avoid the uncomfortable procedure with a simple, noninvasive and reliable test for colon cancer.

Tokai Pharmaceuticals Raises $35.5M to Advance Prostate Cancer Treatment

5/15/2013 05:02 pm

(Boston Business Journal) May 15, 2013 - Cambridge biopharma Tokai Pharmaceuticals Inc. has raised a $35.5M Series E round of funding led by current investors and undisclosed angel investors.

GlobeImmune Initiates Phase 2 Study of a Novel T Cell Stimulating Cancer Vaccine (GI-6207) Targeting CEA in Patients with Metastatic Medullary Thyroid Cancer

4/3/2013 11:05 am

(Reuters) Apr 3, 2013 - GlobeImmune, Inc., announced today the initiation of a Phase 2 clinical trial at the National Cancer Institute (NCI) to evaluate GI-6207 in subjects with medullary thyroid cancer (MTC).