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PDL seeks partner before beginning ulartide phase 3 clinical trials
By Jennifer Lanning Drey
Eugene, Ore., Sept. 22 - PDL BioPharma, Inc. will wait to begin phase 3 clinical trials of ulartide until it has found a partner for the program, Mark McDade, PDL's chief executive officer, said Friday at the Merrill Lynch global pharmaceutical, biotech & medtech conference.
The company had previously planned to begin a 3,000-patient phase 3 clinical trial of the drug for acute decompensated heart failure in the fourth quarter and a 300-patient study in the first half of 2007, he said.
"We believe it's in the best interest of the program to first agree with a partner about what the next steps - particularly in larger trials - should be before embarking on a very heavy investment of PDL time and money," McDade said.
Partnering discussions are underway, and the company's goal is to have a global partnership in place before the end of 2007, he said.
"We do think that will ultimately optimize the results of the program and not jeopardize the results," McDade said.
PDL is moving ahead with an additional phase 1 dose-ranging study of ulartide in order to define dose-limiting toxicity. The Food and Drug Administration told the company it must perform the study before moving into larger clinical trials, according to McDade.
The 40-patient phase 1 clinical trial is on track to be underway by the first quarter of 2007, he said.
McDade also said Friday that PDL plans to begin clinical trials of PDL-063 in multiple myeloma patients in the fourth quarter. The drug is a new humanized antibody with gene and protein targets that have not yet been announced.
Based in Fremont, Calif., PDL markets and sells a portfolio of products in the acute-care hospital setting.
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