The Food and Drug Administration (FDA) authorized, on December 20, 1994, a Treatment IND (Investigational New Drug) program to allow expanded access to Serostim, Serono Laboratories' mammalian-cell derived recombinant human growth hormone. The program permits expanded access to the product for treating AIDS-associated wasting. The Treatment IND was authorized with a cost-recovery program, allowing the firm to recoup costs associated with the manufacture, research, development, and handling of the investigational product.
Entry into the program is limited to those patients that have tried a course of approved therapy for AIDS-related wasting syndrome, where the response has been determined to be poor and where continued treatment with those agents has been judged by the attending physician to be of doubtful promise.
The Treatment IND mechanism was established by FDA to allow patients suffering from serious or life threatening diseases to obtain promising investigational products that have undergone sufficient clinical testing to show that they may be safe and effective.
Serono Laboratories has set up a toll-free information line for physicians, health care professionals, and patients.The Serostim information line is: 1-800-714-2437.Hours of operation are Monday through Friday from 9:00 a.m. to 5:00 p.m., Eastern Time.
Those interested in this Treatment IND, or other AIDS-related studies can also call the AIDS Clinical Trials (ACTIS) Hotline, a free service offering information about AIDS-related clinical trials, at 1-800-TRIALS-A (1-800-874-2572).This service is available Monday through Friday, from 9:00 a.m. to 7 p.m., Eastern Time.