Xcyte drops leukemia program

Xcyte said it will shift further clinical development of its lead product, Xcellerated T Cells, to focus on treating HIV. The company intends to submit an investigational new drug (IND) application to the FDA for the HIV indication in the third quarter of this year, and to initiate the first company-sponsored trial before year-end.

As part of the decision to focus on HIV, Xcyte will discontinue current plans for further development of Xcellerated T Cells in chronic lymphocytic leukemia (CLL).

“The decision to move away from CLL was difficult, both because of the positive clinical effects we have seen in our phase I/II trial and the high level of enthusiasm from our investigators and other CLL experts,” stated Dr Ron Berenson, president and CEO of Xcyte. “However, we have been unable to reach agreement with the FDA on a pathway for regulatory approval in CLL that is feasible or affordable for Xcyte, and we cannot predict when or if we will be able to reach agreement.

“Given the company’s current resources, we believe it is in the best interest of our investors to discontinue further work at this time in CLL, non-Hodgkin’s lymphoma and multiple myeloma and focus our resources on HIV, where recent trials conducted by our collaborators have shown therapeutic effects.”

As well as providing an update on its revised clinical development strategy, Xcyte has also detailed its Q1 2005 financial results, reporting a net loss applicable to common stockholders of $7.3 million for the three months ended March 31, 2005, compared with a net loss applicable to common shareholders of $27.3 million for this period last year. Revenue for the first quarter of 2005 was approximately $16,000, compared with approximately $12,000 for the year earlier quarter.