Cellcor Inc. received FDA approval to make itsautolymphocyte therapy (ALT) broadly available topatients with advanced metastatic renal cell carcinomaunder a treatment investigational new drug application(IND).

ALT, in two Phase III trials for stage III and stage IVkidney cancer, involves an ex vivo procedure designed toactivate the patient's immune system. After removingwhite blood cells, killer and helper T cells are activatedand infused back into the patient to search out and attackcancerous tumors and viruses.

Frederick Miesowicz, senior vice president of scientificaffairs for the Newton, Mass.-based Cellcor, said underthe treatment IND physicians can prescribe ALT to amajority of patients with stage IV kidney cancer, the mostadvanced form of the disease, including those who failedto respond to other treatments.

In addition to making ALT available to patients notparticipating in the current clinical trials, the treatmentIND allows Cellcor to recover costs of providing thetherapy.

In June, Cellcor, short on cash, agreed to a takeover byPrinceton, N.J.-based Cytogen Corp. in a swap of stock.The acquisition is expected to be complete next month.

Miesowicz said from 10,000 to 11,000 patients arediagnosed each year with stage IV kidney cancer. Theirmean survival rate is between eight and 10 months.

Cellcor has completed accrual of 200 patients for itsPhase III trials at 24 medical centers. Participants in thestudies will receive up to 12 monthly infusions of ALTand then will be followed to determine if the therapy canprolong survival. ALT's performance is being testedagainst alpha interferon. Results are expected by the endof 1996.

"Optimally, we're looking at a 1.8-fold improvement insurvival," Miesowicz said.

Patients who are eligible for ALT under the treatmentIND would receive 6 monthly infusions. Additionaltreatments would be given at the discretion of patients'physicians.

In Cellcor's other Phase III trials of ALT for stage IIIkidney cancer, the endpoint is delay of progression of thedisease. Another Phase I trial is under way for chronichepatitis B.

Cytogen (NASDAQ:CYTO) closed Monday at $4.81,down 22 cents. n

-- Charles Craig

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