FDA has given Cellcor Inc. the authorization to recover costs forsupplying patients with Autolymphocyte Therapy (ALT) under acompassionate protocol. The charge will recover the company's directcosts to provide the drug and will exclude research andadministrative costs.
People eligible for inclusion in the protocol are the 190 patients withmetastatic renal cell carcinoma who have received ALT in acommercial or research setting.
Until FDA decided to regulate ALT as a therapy it had beenconsidered a medical procedure, like bone marrow transplantation,and was available commercially. In February, FDA's Center forBiological Evaluation and Review (CBER) established the division ofcellular and gene therapy to establish regulations specifically for thistype of cellular therapy. Cellcor (NASDAQ:CLTX) then decided to ceaseproviding ALT on a commercial basis.
Newton, Mass.-based Cellcor also said that FDA had granted ALTSubpart E designation, which is given to certain indications for life-threatening diseases where there is no viable treatment option.Cellcor chief executive officer Richard D'Antoni said any treatmentgiven a Subpart E designation receives expedited review.
Autolymphocyte therapy involves growing a patient's own whiteblood cells in vitro in the presence of a lymphokine cocktail andantigens to stimulate antibody production; the white blood cells arethen reinjected back into the patient.
Cellcor's first Phase III study of ALT, published in Lancet in April1990, found that kidney cancer patients receiving the drug survivedabout 2.5 times longer than control patients. Cellcor has two ongoingPhase IIIs with ALT, one trial in 94 patients with non-metastatickidney cancer and a dosing trial in 150 patients with metastatickidney cancer. The first of these trials began in 1990 and the secondin 1991. The company expects to begin another Phase III trial thisfall comparing ALT to alpha interferon. The trial will be monitoredby the National Cancer Institute.
In other research, Cellcor is conducting a Phase I trials of ALT fortreatment of prostate cancer and malignant melanoma and is doingpreclinical work for use against hepatitis B. The company is notcurrently pursing ALT for use in AIDS, but D'Antoni said thetechnology could "ultimately have application" in this area.
-- Brenda Sandburg News Editor
(c) 1997 American Health Consultants. All rights reserved.