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UPDATE 1-NexMed says FDA may allow cancer drug into late stage
April 26, 2010 / 10:21 PM / 7 years ago

UPDATE 1-NexMed says FDA may allow cancer drug into late stage

* Says FDA indicates moving drug trial directly to phase 3

* Says FDA clears mid-stage trial

* Shares jump 60 pct

April 26 (Reuters) - NexMed Inc NEXM.O said U.S. health regulators indicated the possibility of moving the company’s experimental first-line treatment for primary liver cancer directly into a late-stage trial, sending its shares up 60 percent in after-market trade.

The U.S. Food and Drug Administration okayed the proposed mid-stage trial of the drug PrevOnco, NexMed said.

To take the drug to a late-stage trial, NexMed would need to expand the proposed mid-stage trial and study PrevOnco in combination with Doxorubicin, a chemotherapy agent, as a second-line therapy for patients who have failed Nexavar, the company said.

The cancer drug Nexavar is approved for use in liver kidney cancer and sold by Onyx Pharmaceuticals Inc ONXX.O and German drugmaker Bayer AG (BAYGn.DE).

“Following this (regulatory) path could be very advantageous for NexMed since advancing the drug directly into a Phase 3 study would save us at least 12-24 months in development time,” Nexmed Chief Executive Bassam Damaj said in a statement.

Shares of the company rose 60 percent to 64 cents after the bell. They closed at $0.40 Monday on Nasdaq. (Reporting by Shailesh Kuber in Bangalore; Editing by Gopakumar Warrier)

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