Verastem Reports Data from Phase 1 Study of VS-6063 (defactinib) in Japanese Patients

On March 5, 2014 Verastem presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063 (Press release Verastem, MAR 5, 2014, View Source;p=RssLanding&cat=news&id=1906472 [SID:1234500516]).
Verastem’s ongoing COMMAND trial is a randomized, double-blind, placebo controlled registration-directed study which is evaluating VS-6063 in patients with mesothelioma and is currently accruing patients in 8 countries.
The Japanese Phase 1 is an open-label, dose-escalation study that enrolled nine subjects who received single-agent VS-6063 (200, 400 or 600mg; n=3 in each dose cohort) BID. The study results demonstrated that VS-6063 was well tolerated at all dose levels. There were no serious adverse events or evidence of dose-limiting toxicity. Pharmacokinetic results from the recommended Phase 2 dose of 400mg BID were consistent with previously reported data in non-Japanese subjects. These safety and pharmacokinetic results support advancing the VS-6063 development program in Japanese patients.

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Alchemia announces in-licensing of FAK inhibitors from CRT

On March 5, 2014 Alchemia Limited (ASX: ACL), a drug discovery and development company, reported the in-licensing of two early-stage novel anticancer drug candidates from Cancer Research Technology (CRT) (Press release, Cancer Research Technology, MAR 5, 2014, View Source [SID1234523230]). The preclinical Focal Adhesion Kinase (FAK) inhibitors originate from the Australian Cancer Therapeutics CRC (CTx) and will be evaluated by Alchemia in various cancer and cancer stem cell models prior to initiation of formal preclinical and clinical development. The two licenses include fees, milestones and royalty payments. Further terms are not disclosed.

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"We are looking forward to evaluating these novel molecules and their effect on the tumour environment and cancer stem cells that are essential for the growth, persistence and reoccurrence of cancer," said Tracey Brown, Alchemia’s Chief Scientific Officer. "We plan to use our established oncology and cancer stem cell models to evaluate the potential clinical benefits of the drugs in vivo prior to initiating further IND enabling studies."

FAK is a non-receptor tyrosine kinase which plays an important role in the development and spread of numerous malignancies and has therefore emerged as a promising target in cancer therapy. Inhibition of FAK has the potential to provide numerous therapeutic benefits to cancer patients by disrupting tumour development and metastasis, while overcoming chemo-resistance to a broad variety of currently used cytotoxic drugs. Through these combined therapeutic effects, FAK inhibitors have the potential to treat a range of cancers and may provide a longer lasting clinical response and improved patient outcomes.

"Alchemia is excited about the in-licensing of these two novel compounds as it will enable our Melbourne-based oncology research team to further evaluate and advance these assets," said Thomas Liquard CEO of Alchemia. "CRT has a stellar reputation for scientific innovation and we are proud that CRT/CTx selected Alchemia to progress these FAK inhibitors."

"CTx was funded under the Australian CRC Program to bridge the gap between excellent Australian research and the discovery of new drugs based on that research," said Warwick Tong, Chief Executive Officer of CTx. "We are excited to see the first drug candidates from our novel pipeline move towards the next stage of their development in the hands of one of Australia’s leading innovative biotech companies."

Genmab Announces Phase III Study of Daratumumab in Relapsed or Refractory Multiple Myeloma

On March 5, 2014 Genmab reported that its partner, Janssen Biotech will start a Phase III study of daratumumab in relapsed or refractory multiple myeloma (Press release Genmab, MAR 5, 2014, View Source [SID:1234500247]). The study will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
This Phase III study will include approximately 500 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).

(Filing, 10-Q, Merrimack, MAR 4, 2014, View Source [SID:1234505642])

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

Qiagen 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 QIAGEN, MAR 3, 2014, View Source [SID1234500243]).

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