Washington Editor

In order to conserve capital for other development programs, Genaera Corp. said it intends to stop enrolling its Phase IIb trial of squalamine in non-small-cell lung cancer patients.

Designed to include 90 patients, enrollment will end at the current 40 patients, Roy Levitt, Genaera's president and CEO, told BioWorld Today.

"There's a balance between continued investment in any program," he said. "The potential upside [is] it will bring business development and further development of the compound. Stopping this program at 40 patients will allow us a sufficient number, in our view, to analyze the data at mid-year as we've promised, for early responses, and then about a year later, in mid-2004, for survival."

According to the Plymouth Meeting, Pa., company, squalamine is the first clinical drug candidate in a class of naturally occurring, pharmacologically active small molecules known as aminosterols. Squalamine is a anti-angiogenic molecule with a multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor (VEGF), the company said.

Aside from non-small-cell lung cancer (NSCLC), Genaera is studying squalamine in two other Phase II trials: one for age-related macular degeneration (the leading cause of blindness in the U.S.) and the other for prostate cancer.

In the multicenter, randomized NSCLC study, patients with Stage IIIB or Stage IV disease are given weekly doses of squalamine, combined with weekly chemotherapy of carboplatin and paclitaxel.

Levitt said the company doesn't believe enrolling the 50 additional patients would dramatically improve its likelihood of gaining a business development deal for continued funding of the program (in NSCLC).

Like the NSCLC study, data from the age-related macular degeneration (AMD) trials is expected around the middle of the year. The prostate cancer trial is being partially funded through a $1.1 million grant from the U.S. Department of Defense, Army Medical Research and Materiel Command.

"We have three programs for this drug, but we can't tell which will succeed," Levitt said. "But AMD, for us, is a real value as a single agent with objective endpoints in this devastating disease that leads to blindness and is the most common cause of blindness in elderly folks."

Meanwhile, the company's other programs are ongoing following its announcement in August to reduce staff and restructure in an attempt to withstand market conditions. (See BioWorld Today, Aug. 16, 2002.)

At that time, the company let go 35 percent of its staff, or 11 people, mostly those working in preclinical research, leaving it with 22 employees.

On Tuesday, Levitt wouldn't discuss specifics about the company's financial situation, saying it had yet to release fourth-quarter numbers. However, he said the company has reduced its burn rate "considerably," so that it would have enough cash to make it to the end of 2003.

At the end of the third quarter, Genaera had $11.9 million in cash and short-term investments, compared to $16.1 million on Dec. 31, 2001.

Levitt said Genaera has two other significant programs, including an ongoing Phase II trial in cystic fibrosis for Lomucin, an oral mucoregulator therapy. He expects to have data from that study by the middle of the year.

Finally, Levitt said, Genaera has an interleukin-9 program partnered with MedImmune Inc., of Gaithersburg, Md., in a deal signed in April valued at upward of $55 million for Genaera. (See BioWorld Today, April 23, 2001.)

Levitt expects the IL-9 program to reach the clinic around mid-year, triggering a milestone payment from MedImmune.

"My perception is, given our clinical programs, we are grossly undervalued, which is in part due to the market we are in," Levitt said.

In late September, NASDAQ notified the company that its common stock had closed for more than 30 consecutive days below the $1 requirement. In October, the company applied for a transfer to the NASDAQ SmallCap Market and on Oct. 30 announced that the request had been approved.

On Tuesday, the company's stock (NASDAQ:GENR) closed at 43 cents, unchanged.