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Executive Summary

Cellcor will expand commercial sales of its autolymphocyte therapy (ALT) technology to three Critical Care of America, Inc., centers under a proposed accord between the two firms. In a preliminary prospectus for an initial public offering dated Jan. 30, Cellcor says it signed a letter of intent with ambulatory care provider CCA on Jan. 29. The letter calls for the joint marketing and delivery of Cellcor's ALT process on a pilot basis for treatment of metastatic renal cell carcinoma (RCC) patients. Cellcor and Critical Care also intend to "explore the joint development, validation and commercialization of Cellcor's lymphocyte-based technology for treating HIV infected patients," the prospectus says. ALT treatment is a multi-step outpatient process in which lymphocytes are removed from a patient's blood and exposed ex vivo to drugs and biologics which activate the T-cell component. The patient is then reinfused with activated cells. Treatment cycles are repeated each month for six months. Cellcor already provides ALT services for metastatic RCC on a commercial basis in Massachusetts, California and Georgia, via three clinical and cell processing centers affiliated with host hospitals: New England Baptist in Boston, St. Joseph Hospital in Orange, Calif. and Atlanta's HCA-West Paces Ferry. "As of Dec. 31, 1991, the company had administered approximately 2,000 cell infusions to 509 research and commercial patients with little or no toxicity experienced," Cellcor says. The company began providing ALT to patients on a commercial basis in May 1990. To date, FDA has not been involved in regulating living cell therapies like ALT, although there are indications that as the number of players in this emerging market increases, the agency may re-evaluate its role ("The Pink Sheet" Jan. 20, p. 11). In the meantime, Cellcor notes that while it has begun commercialization on a limited basis, it also is undertaking several clinical trials under the aegis of FDA. Cellcor says there have been three clinical trials of ALT for RCC, including a company-sponsored Phase III multi-site, randomized, controlled study on ALT for metastatic RCC. Results, published in The Lancet in April 1990, indicated that patients receiving Cellcor's ALT lived 2.5 times longer than the control group, and 21% of metastatic RCC patients receiving ALT "had a significant reduction in tumor," the prospectus notes. Survival at two years was approximately 44%, versus 10% expected survival for patients who do not receive ALT. During 1991, Cellcor initiated a Phase III clinical study under an IND with three independent investigators to evaluate whether continuation of ALT treatments beyond the initial six- month course of treatment will prolong survival. Also, the National Cancer Institute will file an IND this year to compare Cellcor's ALT against alpha interferon in 200 metastatic kidney cancer patients through the East Coast Oncology Group, the prospectus adds. Cellcor also is evaluating a number of additional indications for ALT. The company currently is sponsoring a Phase III study of ALT as an adjuvant therapy in patients with nonmetastatic RCC who have had the affected kidney surgically removed, under an IND submitted to FDA in November 1990. The prospectus registers 2 mil. shares for sale at an expected price of $11 to $13 per share. Furman Selz is underwriting the offering. Proceeds of about $22 mil. ($25.3 mil. if the underwriter's over-allotment is exercised) are expected to fund capital needs through mid-1994, and will support clinical trials, R&D, working capital and other corporate needs. For the year ended Dec. 31, Cellcor reported a net loss of $2.1 mil. on revenues of $1.5 mil. Revenues were up substantially over the previous year due to the addition of two new centers (the Boston site began operations in 1990) and an increase in the percentage of claims paid by third party payers, the prospectus notes.

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