Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Elmer who wrote (64)	5/19/2002 11:43:01 AM
From: dalroi	Respond to of 130

another asco faillure ORLANDO, Fla., May 19 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (NASDAQ:PDLI) today reported the results of a further analysis of the data from the Phase III trial of its humanized antibody Zamyl in patients with relapsed or refractory acute myeloid leukemia. Eric J. Feldman, M.D., Director of the Leukemia Program, Cornell University Medical Center - New York Presbyterian Hospital, and the lead investigator in the trial, will present the results Monday, May 20, during an oral presentation to the 38th Annual Meeting of the American Society of Clinical Oncology in Orlando, Fla. PDL reported that data in the Phase III trial show that the antibody was well tolerated but did not achieve a statistically significant overall response in myeloid leukemia patients who had failed chemotherapy or had relapsed following chemotherapy. The overall response rate in patients who received Zamyl in combination with chemotherapy was 36% (n=94) and was 28% in patients who received chemotherapy alone (n=97)(p=0.28), when all evaluable patients were analyzed on an intent-to-treat basis. PDL also reported that in the Zamyl plus chemotherapy group, 29% achieved a complete response (n=94) and in the chemotherapy alone group, 23% achieved a complete response (n=97)(p=0.41). In December 2001, PDL reported a preliminary analysis of the Phase III data. Those data indicated that Zamyl increased the overall response rate to 43% in the Zamyl plus chemotherapy patients (n=94) from 26% in the chemotherapy alone patients (n=97)(p=0.015), when all evaluable patients were analyzed on an intent-to-treat basis. Differences in the preliminary and final analyses are related to additional data received on a number of patients, such as additional blood cell counts and transfusion information, and to the reclassification of a number of patients by an expert panel of hematologists and oncologists that reviewed the more complete data. In total, the classification of 14 patients, about 7% of the evaluable patients, changed from the preliminary to the final analysis. No significant differences for serious adverse events were seen between the Zamyl treatment and control arms of the trial, nor did the addition of Zamyl to the chemotherapy regimen significantly increase morbidity or mortality when all evaluable patients were analyzed on an intent-to-treat basis. There was no difference in survival when all patients who received Zamyl plus chemotherapy were compared with all patients in the chemotherapy alone group on an intent-to-treat basis. The trial was not powered to show such a difference. However, median survival for all patients who achieved an overall response was 359 days (n=61), compared with a median survival of 111 days for patients who did not respond to treatment (n=130)(p<0.001). Douglas O. Ebersole, acting Chief Executive Officer, PDL, said, "Based on this analysis, we do not plan to seek meetings with regulatory authorities or to consider filing a Biologic License Application for Zamyl at this time. Nevertheless, Zamyl has continued to demonstrate positive trends and possible therapeutic activity, and we expect to explore partnering opportunities that would allow continued development of this novel, humanized antibody." In these analyses, minimal requirements for an overall response were a bone marrow biopsy that demonstrated 5% or fewer blast cells, a normal absolute neutrophil count and transfusion independence. The overall response category included patients who made a complete hematologic recovery as well as patients whose platelet counts were less than 100,000 per cubic millimeter. Patients were classified according to this definition without knowledge of their respective treatment assignments. The data were also analyzed based upon a more stringent definition of complete response, which required complete hematological recovery, including a normal platelet and absolute neutrophil count and transfusion independence. Both the overall response and the complete response were required to last at least 28 days. Zamyl is a humanized antibody that binds to the CD33 antigen on myeloid leukemia cells. It is the humanized version of the murine M195 monoclonal antibody. The foregoing contains forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in PDL's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, and in its Annual Report on Form 10-K for the year ended December 31, 2001, as amended. Protein Design Labs, Inc. is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its antibody humanization technology. For further information, visit www.pdl.com.