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March 31, 2014
10:58 EDTOXBT, CRISCuris, Oxygen Bio advance after FDA lifts clinical holds on treatments
Shares of both Curis (CRIS) and Oxygen Biotherapeutics (OXBT) are higher this morning after the Food and Drug Administration lifted clinical holds on treatments being tested by the companies. Curis is a drug discovery and development company that is committed to leveraging signaling pathway drug technologies in seeking to develop next generation network-targeted cancer therapies; Oxygen Biotherapeutics is engaged in the business of developing biotechnology products with a focus on oxygen delivery to tissue. CURIS: Curis said the FDA allowed it to resume testing of CUDC-427, its experimental cancer drug, lifting a November 2013 order halting enrollment in an early-stage trial. The trial was put on partial clinical hold in November following the death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. The company says the monotherapy Phase 1 study will re-open "as soon as possible." Curis President and COO Ali Fattaey said the company believes CUDC-427 has "significant potential" as an anti-cancer agent and that the company expects to proceed with CUDC-427's overall development plan, "including our planned study to investigate CUDC-427 in combination with capecitabine in HER-2 negative advanced breast cancer patients." OXYGEN: Separately, Oxygen Biotherapeutics this morning said it received written confirmation from the FDA that the clinical hold on its Oxycyte development program was lifted following its review of the September 12, 2013, submission to the investigational new drug application for Perfluorocarbon Oxycyte. The FDA said the company has addressed all clinical hold issues. PRICE ACTION: Curis is trading up 7c, or 2.55%, to $2.82 in morning trading. Meanwhile, Oxygen Biotherapeutics is up 25c, or 4.65%, to $5.63.
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