Cellcor Inc. and Organon Teknika/Biotechnology Research Instituteare collaborating on a Phase I clinical trial for patients with advancedkidney cancer.Richard D'Antoni, Cellcor's president and CEO, said he expects FDAapproval to begin the trial in the next several weeks.The study will involve up to 15 patients who will receive bothOrganon's active specific immunotherapy (ASI) and Cellcor'sautolymphocyte therapy (ALT).The Phase I trial will examine the safety of the combined therapies andthe companies will be looking for enhanced immune response in thepatients. The trial will be conducted at the Georgetown UniversityMedical Center's Lombardi Cancer Research Center.The goal, D'Antoni said, is to use Newton, Mass.-based Cellcor's ALT,which involves the ex vivo activation of a patient's T cells, to amplifythe effect of Rockville, Md.-based Organon's ASI, which is anautologous tumor cell/BCG vaccine.Patients with stage IV metastatic renal cell carcinoma first will betreated with ASI and those who respond will be treated with ALT.According to D'Antoni, the objective is that patients responding to ASImay develop tumor specific T cells in response to the immunizationand that effect may be further enhanced or prolonged by subsequent exvivo T cell activation (ALT) and re-infusion."This would be a one-two punch," D'Antoni said. Both therapies aredesigned to reduce or slow the growth of cancerous tumors.Both Cellcor and Organon are conducting independent clinical trials oftheir technologies for treatment of kidney cancer. Cellcor's ALTcurrently is in Phase III trials and Organon is in Phase I/II trials. _Charles Craig
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