Duh!
Tuesday May 14, 4:07 pm Eastern Time
Press Release
SOURCE: Abgenix
Phase 2B ABX-IL8 Study in Psoriasis Does Not Meet Primary Efficacy Endpoint
FREMONT, Calif.--(BW HealthWire)--May 14, 2002--Abgenix, Inc. (NASDAQ:ABGX - News) today released results of a Phase 2b study in patients with moderate to severe psoriasis that showed treatment with ABX-IL8 did not result in a significant improvement in PASI scores, the primary efficacy end point of the trial. Based on these findings, Abgenix is discontinuing clinical development of ABX-IL8 in psoriasis. In addition, the company will not proceed with a previously planned clinical study of ABX-IL8 in melanoma and will wind down its ongoing Phase 2a study in chronic obstructive pulmonary disease (COPD). Abgenix currently has no plans to conduct further clinical studies involving ABX-IL8.
As a result, Abgenix does not expect to receive revenue from an ABX-IL8 commercial collaboration this year and is now less likely to achieve its previously announced revenue target for 2002, although alternative sources of revenue are being explored. Despite this, Abgenix maintains its current operating loss guidance, before depreciation and amortization of intangibles, of $105-$120 million. Abgenix intends to achieve this from the reduced expense of clinical trials for ABX-IL8 and, if sufficient replacement revenue is not generated, by slowing previously planned headcount growth as needed.
"We are surprised and disappointed that we were unable to replicate the efficacy results shown in the phase 2a study, but we believe it is a prudent decision to curtail the ABX-IL8 program," said Ray Withy, Ph.D., president and chief executive officer of Abgenix. "We will continue to execute on our strategy of building a broad portfolio of antibody products along with the required development and manufacturing infrastructure to support such a pipeline."
The double-blind, placebo-controlled Phase 2b study randomized 256 patients to placebo, 200 mg or 300 mg of ABX-IL8 at 32 sites in the U.S. ABX-IL8 was administered every three weeks for a total of five doses. Patients were assessed at each visit and observed for up to 24 weeks after the last dose. The study's primary endpoint was the proportion of patients achieving greater than or equal to 75 percent improvement in their Psoriasis Area Severity Index (PASI) scores at Week 15 compared to baseline.
The study found ABX-IL8 was well tolerated and demonstrated an excellent safety profile. The incidence of adverse events was similar in both ABX-IL8 and placebo-treated patients. To date, no human anti-human antibodies were detected at any time point in any patient. The results showed that 3 percent of placebo-treated patients experienced greater than 75 percent improvement, compared with 2 percent of patients treated with 200 mg ABX-IL8, and 6 percent of patients treated with 300 mg. Although a retrospective analysis of study results found that ABX-IL8 reduced a measure of plaque thickening (a secondary endpoint) in the most severe patients, this result was not clinically significant. The complete findings of this study will be presented tomorrow at the 63rd Annual Meeting of the Society for Investigative Dermatology in Los Angeles, California.
Abgenix is a biopharmaceutical company focused on the development and commercialization of human therapeutic antibodies. The company's technology platform, which includes XenoMouse® and XenoMax(TM) technologies, enables the rapid generation and selection of high affinity, fully human antibody product candidates to a variety of disease targets. Abgenix leverages its leadership position in human antibody technology by building a diversified product portfolio through the development of its own internal proprietary products and through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies. For more information on Abgenix, visit the company's website at www.abgenix.com.
Abgenix will hold a conference call at 5:30 PM EST today to discuss these developments. Interested parties may listen to the call by dialing 800-967-7135 and mentioning the "Abgenix Conference Call." A copy of the ABX-IL8 poster to be presented at the Society of Investigative Dermatology is also available upon request. A replay of the call will be available starting at 8:30 PM EST on May 14, 2002 through 11 PM EST on May 22, 2002. To listen to the replay, dial 888-203-1112 and enter the replay access code 701209 when prompted.
Statements made in this press release about Abgenix's technologies, product development activities and collaborative arrangements other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and the extent and breadth of Abgenix's patent portfolio. Please see Abgenix's public filings with the Securities and Exchange Commission for information about risks that may affect Abgenix.
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Contact:
Abgenix
Ina Cu, 510/608-4662
or
Ami Knoefler, 510/284-6350 |
