Celtrix Substantially Bolsters Its Patent Portfolio.SAN JOSE San Jose, city, United States San Jose (sănəzā`, săn hōzā`), city (1990 pop. 782,248), seat of Santa Clara co., W central Calif.; founded 1777, inc. 1850. , Calif.--(BW HealthWire)--Feb. 18, 1999--Celtrix Pharmaceuticals, Inc. (Nasdaq:CTRX CTRX Contractions (labor & delivery) ) announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office on a key patent application relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc therapeutic delivery of its lead product candidate, SomatoKine(R) (IGF-I/BP3 complex). The allowed patent claims specific methods of delivering effective doses of IGF-I IGF-I see somatomedin C. IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with using SomatoKine to treat any indication. The allowed claims of this patent application cover IGF-I dose levels which the company has tested in several recently completed Phase II clinical feasibility studies. The allowed claims cover routes of administration and delivery techniques that may be desirable alternatives to frequent subcutaneous injections. "What is particularly exciting about this patent is the breadth of its claims, specifically the coverage of all indications," commented Andreas Sommer Sommer is a surname, from the German and Danish word for the season "summer". It may refer to:
pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. and renal indications, this new patent claims the use of SomatoKine to deliver IGF-I at dose levels that the company believes are necessary for efficacy. In earlier Phase I clinical safety studies and in several recently completed Phase II clinical feasibility studies, the company has demonstrated that such dose levels can be safely administered using its SomatoKine technology." Celtrix has also added other patents to its portfolio in recent months: U.S. patents covering various aspects of a manufacturing process for SomatoKine; the use of SomatoKine for the treatment of certain renal disorders; and a method for predicting how a patient will respond to SomatoKine. Celtrix currently owns 19 issued or allowed U.S. patents, and 21 families of patent applications relating to the composition, production, diagnostics and methods of therapeutic use for SomatoKine. The SomatoKine Complex SomatoKine is the recombinant equivalent of the natural complex formed by the hormone insulin-like growth factor-I (IGF-I) and its major regulatory binding protein (BP3). IGF-I plays multiple roles in diverse biological processes, including preservation and formation of bone and muscle. IGF-I also plays a key role in the control of blood glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence . BP3 contains biological information important for the body's natural regulation of IGF-I bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. and biodistribution. Administration of SomatoKine, the IGF-I/BP3 complex, establishes a circulating reservoir of IGF-I that is proving in clinical research to be both safe and effective. Additional Information Celtrix is a biopharmaceutical company developing therapeutics for seriously debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction , degenerative conditions primarily associated with severe trauma, chronic diseases or aging. The company's focus is on SomatoKine, the novel IGF-I/BP3 complex, for treatment of a broad range of metabolic disorders. Celtrix has recently completed Phase II feasibility trials in severely osteoporotic patients recovering from hip fracture hip fracture Orthopedic surgery A femoral fracture which affects 1/6 white ♀–US during life Epidemiology 250,000/yr–US Specifics Proximal femur; 90+% femoral neck, intertrochanteric; 5-10% are subtrochanteric Risk factors Tall, thin ♀, surgery and patients undergoing treatment for traumatic burns. The company has nearly completed Phase II clinical testing for the treatment of diabetes. Celtrix has also licensed rights for development of another molecule, TGF-beta-2, to Genzyme Corporation for incorporation into their comprehensive program for tissue repair. TGF-beta-2 is currently in Phase II clinical testing for treatment of dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. ulcers. This news release contains certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Actual results may differ materially from the statements made, as a result of various factors, including risks associated with the issuance and continuation of the patents referred to in this press release, ability of the company to enter into a collaboration with a corporate partner for the continuation of the clinical trials, that such trials will continue to show the same observations, including any statistically relevant results in larger Phase II or Phase III trials, as well as risks associated with future research, the regulatory approval process, competitive products and other factors which are listed from time to time in Celtrix's Securities and Exchange Commission (SEC) filings. These forward- looking statements represent Celtrix's judgment as of the date of this news release. |
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