By David N. Leff

BETHESDA, Md. --- A molecule characterized by its inventor as “germane to almostevery branch of medicine“ is available for licensees to develop.

The National Institutes of Health's Office of Technology Transfer (OTT) recentlyforwarded to the Federal Register an offer to license Transforming GrowthFactor-Beta (TGF-_) non-exclusively and worldwide. The notice seeks “expeditiouscommercialization“ of U.S. Patent No. 5,104,977, issued April 14, 1992, plus patentapplication No. 08/048/956, filed April 16 and titled “Promotion of CellProliferation by Use of TGF- _.“

Michael Sporn, who directs the National Cancer Institute's chemoprevention laboratory,is the principal inventor of the all-purpose peptide, which consists of two identicalchains of 112 amino acids each. Among its near-universal properties, “TGF-_ is themost potent known endogenous suppressant of lymphocyte proliferation and function; it is10,000 to 100,000 times more potent ... than cyclosporin,“ said Sporn.

Sporn cited among other things the patented peptide's potential utility in tissue andbone repair, chemoprevention of cancer, healing of surgical wounds, diabetic and decubitusulcers, burn injuries, retinal detachment and bone fractures.

OTT is soliciting in particular developers for systemic and non-systemic administrationof TGF-_ in three fields of human therapy:

• wounds and similar invasive procedures before, during and after surgery;

• autoimmune diseases;

• ophthalmic diseases, notably retinal detachment.

The licensure offer expressly excludes:

• non-systemic use for soft-tissue repair;

• treatment or prevention of musculoskeletal disease;

• periodontal disease.

Since the late 1980's, Genentech Inc. has held exclusive rights to the NIH's TGF-_ forcertain undisclosed uses. On Nov. 22, 1989, the company filed a U.S. patent applicationfor a “latency-associated peptide ... useful as a co-treatment therapy with matureTGF-_.“

Early this year, Genentech signed a cross-licensing pact with Celtrix Pharmaceuticalscovering TGF-_ and its receptors. As a result, the companies swapped rights to certainprocess patents previously assigned to each.

OTT licensing specialist Marjorie Hunter is managing the current bid for new TGF-_licensees (301) 496-7735.