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PA-457 Disappointing Study Results

Test of HIV drug disappointing, firm says

Washington Business Journal - 9:41 AM EST Wednesday
by Vandana Sinha

Panacos Pharmaceuticals reported that its tablet to treat HIV did not work as well as hoped in preliminary tests, but the company plans to seek approval to test a higher-dose version.

The drug, bevirimat, was tested in a Phase IIb study on HIV-infected patients who failed previous traditional treatments.

Watertown, Mass.-based Panacos, which owns a research facility in Gaithersburg, says that during a two-week treatment cycle a 400-milligram version of the tablet performed similar to lower milligram versions in other trials.

Panacos says new formulations of the 400-milligram tablet may have resulted in the lower-than-expected response. It says the tablet did do well in terms of overall antiviral response and safety.

"While this first cohort did not produce the bevirimat levels we had hoped for, we were encouraged that some patients exhibited a very good antiviral response," says Graham Allaway, president and chief operating officer in a statement. "We believe the results support going to higher doses, potentially with alternative formulations, with the aim of generating greater responses."

The company says it plans to apply to the Food and Drug Administration to hike up the dose in the Phase IIb study "as soon as possible."

Panacos (NASDAQ: PANC) announced the test results after the closing bell. The share price, which closed Tuesday at $5.69 after a nearly 6 percent drop, plummeted even further in after-hours trading. It fell 35 percent or $1.99, to $3.70, which was 50 cents beneath the 52-week low.


Panacos shares plunge

MarketWatch - Dec. 20, 2006

BOSTON (MarketWatch) - Panacos Pharmaceuticals shares nose-dived early Wednesday, the morning after the biotech group reported disappointing Phase II clinical results for its HIV drug candidate bevirimat.

Shares of Panacos PANC were down 35% at $3.68 in morning trading.

Late Tuesday, Panacos said that patients in a Phase IIb clinical trial for bevirimat had a lower than expected response rate to the drug. The company added that the patients were also observed to have lower than anticipated levels of the drug in their systems, suggesting that the drug's tablet formulation may have affected its delivery.

"While this first cohort did not produce the bevirimat levels we had hoped for, we were encouraged that some patients exhibited a very good antiviral response," said Panacos president Graham Allaway, in a statement on Tuesday.

Panacos has been testing bevirimat on HIV patients who are not responding to other standard drug therapies. Bevirimat is Panacos' lead drug candidate.

The results of the drug trial are just the latest setback for Waltham, Mass.-based Panacos. The company's chairman and chief executive officer, Samuel Ackerman, died suddenly of a heart attack in June. Panacos' chief financial officer, Peyton Marshall, has been serving as interim CEO until a successor is found.