Cellcor Inc. released Phase III results Friday of a trial started in 1991that showed extended treatment of autolymphocyte therapy (ALT) inadvanced kidney cancer patients extended survival nearly twice aslong as historical cohorts.
The Newton, Mass., company's trial enrolled 150 patients whoinitially were put on a six-month core ALT regimen. Patients thenwere randomized into three treatment groups to receive maintenanceALT monthly, quarterly or delayed for nine months followed byquarterly treatments.
No statistical differences were seen between the three maintenanceschedules, but median survival of the 150 patients was 27 monthscompared to six to 13 months for historical patient groups receivingother therapies _ interleukin-2, chemotherapy and alpha interferon.
"We would like to have had the question we asked answered, interms of if there was a preferred maintenance schedule," RichardD'Antoni, Cellcor's president and CEO, told BioWorld. "But we arecertainly pleased with the extended survival and durability of thetumor responses."
An earlier Phase III trial of ALT, which included a control arm,showed a median survival time of 20 months. But D'Antoni saidmany of the patients in that study did not receive the full six-monthtreatment.
The trial results released Friday also showed that patients mayreceive routine ALT for years without serious side effects. Theeffects, D'Antoni said, mostly were related to the taking ofcimetidine in conjunction with ALT, and included nausea, chills andfever associated with the infusion of cells. "They are self-limitingand resolved in the outpatient clinic," he said.
ALT involves activating a patient's own white blood cells in vitro inthe presence of a rich mixture of autologous cytokines and anti-CD3monoclonal antibodies. Patients' cells are sent to Cellcor's cellprocessing facility in Newton for activation, then sent back to beinfused into the patient.
A Phase III trial comparing ALT to alpha interferon is ongoing. It isintended to evaluate survival, with secondary endpoints of tumorresponse, quality of life and cost effectiveness. D'Antoni said about70 of 180 patients have been enrolled in the trial.
He said Cellcor hopes to complete accrual in the first half of 1995,and have results about a year later. "That's the final trial we're goingto have before filing a PLA [product license application] and ELA[establishment license application]," D'Antoni said. "We've treated alarge number of patients  with this technology and we continueto be encouraged by the extended survival and quality of life of thesepatients," he said.
Cellcor also has a Phase III trial of ALT ongoing at 11 sites for non-metastatic kidney cancer, with the endpoint of delaying metastaticdisease. The company has conducted early stage studies of thetherapy in malignant melanoma and hormone-resistant prostatecancer, where safety and biological activity were shown, D'Antonisaid.
"Because the T cell activation is antigen-independent, we believe itwill have applications in other solid tumors," he said. But thecompany lacks the money to go forward in other areas at this time."We're focusing our resources on getting this approved [in theadvanced kidney cancer indication]," D'Antoni said, adding that thisis the first cellular therapy in a pivotal Phase III U.S. trial where theproduct is the cells.
The FDA granted orphan status to ALT treatment for kidney cancerthis past summer. Cellcor recently expanded its ongoing Phase IIItrial into Canada, a significant aspect of which is the approvalsgained from health and customs officials to transport blood betweenthe countries.
Cellcor and Organon Teknika/Biotechnology Research Institute, ofRockville, Md., are collaborating on a Phase I trial for patients withadvanced kidney cancer. The study involves patients who receiveALT and Organ's active specific immunotherapy.
And, D'Antoni said, "We're about to embark upon our firstinfectious disease indication, chronic hepatitis B," for which Cellcoris getting ready for a Phase I trial.He said the company is "lookingfor partners, primarily overseas, but we certainly would consider amarketing partner in the U.S. and Canada."
Cellcor has the cash to last it through the summer of 1995, D'Antonisaid, and has about 7.1 million shares outstanding on a fully dilutedbasis. Cellcor stock (NASDAQ:CLTX), which is lightly traded andnot tracked closely by analysts, closed unchanged Friday at $4 pershare. n
-- Jim Shrine
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