Agios Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing 10-K , Agios Pharmaceuticals, FEB 24, 2015, View Source [SID1234501854]).

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On February 23, 2015 Taiho Pharmaceutical reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission of a New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride, brand name in Japan: "Lonsurf combination tablet T15, T20"). TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC). The PDUFA goal date is December 19, 2015 (Press release, Taiho, FEB 23, 2015, View Source [SID:1234502140]).

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Results from the Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies, form the foundation for the NDA. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.

About TAS-102
TAS-102 is an oral combination investigational anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 was approved initially in Japan in March 2014 for the indications of "unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)," based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May 2014 under the brand name "Lonsurf combination tablet T15, T20".

On February 23, 2015 Prescient Therapeutics (ASX: PTX), a clinical stage oncology company, announced today that the U.S Patent and Trademark Office has granted two additional patents that underpin the development and commercialisation of its drug candidate PTX-200. U.S. patent 8,906,869, provides broad protection for the company’s novel method of treating chemotherapy resistant ovarian cancer with the AKT inhibitorcompound PTX-200, formerly known as TCN-P or triciribine phosphate monohydrate (Press release, Prescient Therapeutics, FEB 23, 2015, View Source [SID1234517542]). The second U.S. patent 8,901,086, provides broad coverage for treating various cancer types including breast cancer by administering PTX-200 in combination with trastuzumab.

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Dr. Robert Crombie, Managing Director of Prescient Therapeutics, said, "These U.S. patents further enhance our intellectual property portfolio. They confirm our monopoly rights on this novel and highly encouraging compound which we believe has significant potential to improve the clinical outcome for women with chemotherapy-resistant ovarian cancer."

"Prescient’s drug candidate PTX-200 is being trialed in patients who have become resistant to platinum-based drugs as it inhibits the AKT tumor survival pathway associated with platinum drug resistance PTX-200, in combination with standard of care drug carboplatin, is currently in Phase 1b/2 trial as a new therapy for ovarian cancer, the fifth leading cause of cancer death in women in the United States. Currently approximately half of the patients diagnosed with ovarian cancer will die from metastatic disease as they become resistant to the platinum-based drugs that constitute front line therapy. Prescient’s drug candidate PTX-200 is aiming to minimise this resistance."

Rich Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Rich Pharmaceuticals, FEB 23, 2015, View Source [SID1234501840]).

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Ligand has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing 10-K , Ligand, FEB 23, 2015, View Source [SID1234501847]).

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