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117 Fourth Avenue
Needham, MA 02494 USA
Toll free: 800-622-2259
Please notice: This entry hasn't been updated by the submitting company for more than 2 years. It could be possible that this company doesn't longer exists.
Repligen Corporation (Nasdaq: RGEN) is a biopharmaceutical company engaged in the discovery of novel therapeutics for autism, organ transplant and cancer. Repligen’s products offer patients improved treatment options based on modulation of newly discovered disease mechanisms. The Company’s major programs currently include developing the hormone secretin for use as an autism therapy, enabling bone marrow transplants between genetically unmatched donors using CTLA4-Ig, and manufacturing and marketing Protein A to biopharmaceutical companies for use in the manufacture or production of therapeutic antibodies.
Secretin has been reported to have benefits for some autistic children including increased awareness, improved social behavior and communication. In addition, many autistic children with chronic gastrointestinal disorders have had marked improvements which last for weeks to months. Repligen plans to manufacture a synthetic, human form of secretin, and pending regulatory approval, initiate a multi-dose Phase II clinical trial in autism patients in early 2000. This trial will take place at several centers which will enroll in total more than 100 children. The trial will assess the safety and efficacy of secretin on both physiological endpoints (sleep, gastrointestinal function) as well as communication and behavior. The Company intends to seek approval from the FDA for this trial at the end of this year. Pending approval from the FDA, recruitment for the clinical study will be carried out by the clinical trial sites which will be announced in several months.
CTLA4-Ig was developed to enable bone marrow transplants between genetically unmatched family members. The June 3, 1999 issue of the New England Journal of Medicine reported the results of a recent study in which the drug was evaluated for its ability to block the development of Graft Versus Host Disease (GVHD), a condition in which the newly transplanted marrow attacks the recipient or "host." Researchers from the Dana-Farber Cancer Institute, Boston, reported that the immune reactivity of the transplanted marrow against the host was reduced, on average, by nearly 100-fold, or 99 percent. In addition, the immune suppression induced with CTLA4-Ig was specific for those T-cells responsible for GVHD, which indicates that beneficial immune responses were not compromised, unlike other GVHD-blocking approaches whose non-specific immunosuppressants can leave the patient vulnerable to infection.
Repligen recently secured an agreement to supply recombinant Protein A to Amersham Pharmacia Biotech (AP Biotech) for the next ten years. Protein A, Repligen’s principal marketed product, is used for the safe and effective production of therapeutic antibodies. AP Biotech will incorporate Protein A into its products for sale to the pharmaceutical industry.
Last update of this entry: November 19, 1999