Status of clinical trials as of 7/25/97 (for comparison)
CLINICAL TESTS
In March 1994, the Company commenced human clinical trials in the United States, under protocols approved by the FDA, to evaluate the effectiveness of the Company's Composite Cultured Skin on burn patients. Since then eight patients were treated as part of such human clinical trials, one at Cornell Medical Center in New York City and the other seven at the Westchester Medical Center in Valhalla, New York. It is too early to draw conclusions about the safety and efficacy of the Company's product because of the limited number of such operations to date and because more time is needed, under the clinical trial protocol filed with the FDA, to assess the results of these and future operations.
From 1988 through July 15, 1997, 29 operations were conducted in Sydney, Australia, using the Company's Composite Cultured Skin. Five of those operations were performed on burn patients. Four operations were performed to remove tattoos. The remaining operations were conducted for treating the symptoms of EB. None of the operations in Australia were performed in accordance with the FDA approved protocols. The Company does not intend to use the results of any of its Australian operations as part of the 120 FDA required human clinical trials.
Under the FDA approved clinical trial protocol, 120 patients are required to be enrolled in at least five clinical sites located in various burn centers in the United States. Each patient's progress must be followed for one year following the procedure. The patients for the FDA mandated human clinical trials are persons treated at the hospitals at which such clinical trials are performed.
The Company has been relying almost exclusively on the burn unit in Westchester Medical Center for patients for its FDA mandated human clinical trials. Since its protocols filed with the FDA limit the burn patients that can be treated in the human clinical trials (based on age, the parts of the body to be treated, the patient's other medical problems and the availability of skin for simultaneous autograft transplants for comparison purposes), as well as by the requirement for informed consent, the Company believes that it must establish working relationships with burn units in other hospitals to increase the number of patients available for its clinical trials. Jacobi Hospital in New York City has agreed to use the Company's Composite Cultured Skin at that hospital's burn center as part of the Company's human clinical trials. To date, Jacobi Hospital has not conducted any human clinical trials.
In 1996, the FDA approved the protocols of Rockefeller University Hospital in New York City for the use of the Company's Composite Cultured Skin for the treatment of non-healing skin ulcers of patients with EB. Under this FDA approved clinical trial protocol, ten to fifteen patients are required to be enrolled at a clinical site. Human clinical trials are presently being conducted at Rockefeller University Hospital for treatment of ulcers in EB patients. |
