* Says FDA indicates moving drug trial directly to phase 3
* Says FDA clears mid-stage trial
* Shares jump 60 pct
April 26 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
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
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