10-Q – Quarterly report [Sections 13 or 15(d)]

Celator Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Celator Pharmaceuticals, MAY 12, 2014, View Source [SID1234500520]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Nothing new in cancer

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10-Q – Quarterly report [Sections 13 or 15(d)]

As of April 2014, it is in the 7th cohort of patients. The dose escalation continues to progress as they have not yet observed any DLTs or the MTD (Filing 10-Q , CellCeutix, MAY 12, 2014, View Source [SID:1234500521]). The company anticipates this endpoint will be reached in the second half of 2014.

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8-K – Current report

In January of 2014, patient enrollment in its Phase 3 study of the CPX-351 in patients 60-75 years of age with high-risk (secondary) AML, reached 50% of the study’s planned enrollment of 300 patients (Filing 8-K , Celator Pharmaceuticals, MAY 12, 2014, View Source [SID:1234500519]). Patient enrollment is currently on track to be completed in the fourth quarter of 2014.

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Verastem Announces Initiation of COMMAND Study in Japan

On May 12, 2014 Verastem reported the expansion of its ongoing COMMAND study to include clinical trial sites in Japan. COMMAND is a registration-directed trial evaluating the Company’s lead candidate targeting cancer stem cells, VS-6063 (defactinib) a potent inhibitor of focal adhesion kinase (FAK), in patients with malignant pleural mesothelioma (Press release Verastem, MAY 12, 2014, View Source;p=RssLanding&cat=news&id=1929651 [SID:1234500515]). Mesothelioma is a highly aggressive form of lung cancer and a high percentage of cases contain cancer stem cells. With the inclusion of Japan, COMMAND is now accruing patients and pursuing parallel clinical development in the major markets worldwide.
Verastem recently reported the successful outcome of its Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors. The study results demonstrated that VS-6063 was well tolerated at all three dose levels tested. The data were consistent with the results from the US Phase 1 trial and there were no serious adverse events or evidence of dose-limiting toxicity. These results supported the Company’s application to the Japanese PMDA for the initiation of clinical trial sites to evaluate VS-6063 in Japanese patients with mesothelioma.

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