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Bayer Initiates Phase III Trial of Radium-223 Dichloride in Combination with Abiraterone Acetate for Patients with Metastatic Castration-Resistant Prostate Cancer

On April 2, 2014 Bayer HealthCare reported that the company has begun to enroll patients in a new Phase III trial with radium-223 dichloride (radium-223, Xofigo) (Press release Bayer, APR 1, 2014, View Source;L=1&tx_news_pi1%5Bnews%5D=1672 [SID:1234500360]). The study evaluates radium-223 in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (CRPC). The trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival (SSE-FS).

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(Filing, 10-K, Stemline Therapeutics, MAR 31, 2014, View Source [SID:1234502714])

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Can-Fite BioPharma has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release Can-Fite BioPharma, MAR 31, 2014, View Source [SID1234500352]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A Phase II dose response/dose-confirmation study in patients with advanced cancer is planned (Filing 10-K, TNI BioTech, MAR 31, 2014, View Source [SID:1234501363])

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Otsuka Acquires Rights to Hematological Cancer Treatment Dacogen® From Eisai (U.S.)

On March 31, 2014 Otsuka Pharmaceutical reported an agreement with Eisai to acquire rights to the hematological cancer treatment Dacogen and to an enzyme inhibitor, E7727 (Press release Otsuka, MAR 31, 2014, View Source [SID:1234500356]).
Rights Acquired From Eisai:
Exclusive rights to the development and sale of DNA methylation inhibitor Dacogen, an intravenous formulation of decitabine (generic name), in the U.S., Canada, and Japan in addition to the licensing rights worldwide excluding Mexico. Eisai will retain the rights in Mexico. Janssen Pharmaceutical Companies will retain its worldwide development and commercialization rights (excluding the U.S., Canada, Mexico and Japan).
Patent rights to metabolic enzyme inhibitor E7727, currently in pre-clinical development by Otsuka’s U.S. subsidiary Astex Pharmaceuticals, Inc. E7727 is in development together with decitabine to form the combination product ASTX727 (an oral hypomethylating agent), which if approved would become the first oral formulation of decitabine.

Otsuka will continue its existing decitabine-related business through Astex Pharmaceuticals, a U.S. subsidiary, concurrent with advancing clinical development of ASTX727 with the aim to provide an alternative, early-stage option in the treatment of MDS.