Altus Pharmaceuticals Reports Dosing First Patient in a Phase 2 Trial of ALTU-238 for Pediatric Growth Hormone Deficiency.- - Company's Vice President of Clinical Development To Present at The Endocrine Society's 91st Annual Meeting - - WALTHAM, Mass. -- Altus Pharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ALTU) today announced that patient dosing in its Phase 2 trial for ALTU-238 in growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. subjects began on June 2, 2009. ALTU-238 is a long-acting, extended-release formulation of recombinant human growth hormone human growth hormone (HGH): see growth hormone. (rhGH, somatropin), which is being developed utilizing Altus' proprietary protein crystallization Crystallization The formation of a solid from a solution, melt, vapor, or a different solid phase. Crystallization from solution is an important industrial operation because of the large number of materials marketed as crystalline particles. technology. ALTU-238 is a ready-to-use liquid suspension of crystallized rhGH that preserves the structure of the rhGH molecule without the need for pegylation, polymerization polymerization Any process in which monomers combine chemically to produce a polymer. The monomer molecules—which in the polymer usually number from at least 100 to many thousands—may or may not all be the same. , or encapsulation and enables administration through a fine gauge needle. The Phase 2 ALTU-238 pediatric trial is being conducted in approximately 18 clinical sites in the U.S. and targets enrolling 36 growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). deficient pediatric patients. ALTU-238 has been studied in a series of Phase 1 and Phase 2 studies in healthy and GH deficiency adults. "Moving this pediatric trial forward is an important step in re-establishing the value of the ALTU-238 program and Altus," stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. "This Phase 2 pediatric trial is the fifth clinical study to evaluate ALTU-238. Previous ALTU-238 studies have demonstrated pharmacokinetic and pharmacodynamic (PK/PD PK/PD Pharmacokinetic/Pharmacodynamic ) profiles that are supportive of and consistent with a once-per-week dosing regimen." The Company is also announcing that Kenneth Attie, M.D., Vice President of Clinical Development and Medical Affairs at Altus Pharmaceuticals, will be presenting results from a key Phase 1 study in the ALTU-238 development program at The Endocrine Society's 91st Annual Meeting in Washington, D.C. at the Washington Convention Center The Washington Convention Center has been the name of two convention centers in Washington, D.C. The old Washington Convention Center was located at 909 H Street NW and was in use from 1983 until 2004. on Wednesday, June 10, 2009. The Endocrine Society's Annual Meeting (ENDO ENDO Endometriosis ) is a leading forum for physicians and other clinicians who treat endocrine conditions, including growth hormone disorders. Dr. Ken Attie stated, "As we present this Phase 1 data and start the Phase 2 trial, we believe ALTU-238 has the opportunity to demonstrate its unique advantages compared to daily growth hormone products as well as the other long-acting growth hormone candidates that are in development." Dr. Attie will be presenting a poster entitled, "Pharmacokinetic, Pharmacodynamic and Safety Results of ALTU238, a LongActing, Crystalline Recombinant Human Growth Hormone, in Healthy Adults." The ALTU-238 Phase 1 trial evaluated the safety and PK/PD profile of a single dose of weekly ALTU-238 compared to seven injections of daily growth hormone. ALTU-238 was well tolerated in the one-week study that included 36 healthy, adult subjects. In addition, the Phase 1 PK/PD data is consistent with prior ALTU-238 clinical studies that supported a once-per-week dosing regimen. The Phase 1 trial results also indicate that the ALTU-238 material, produced at the current increased manufacturing scale, performs similarly to the material used in previous ALTU-238 studies. About Altus Pharmaceuticals Inc. Altus Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics. The Company's website is www.altus.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Certain statements in this news release concerning Altus' business are considered "forward-looking statements". These statements include, but are not limited to, the expected ALTU-238 advantages compared to daily growth hormone products as well as the other long-acting growth hormone candidates, the timing for patient enrollment in the Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. for ALTU-238, and the future of the ALTU-238 program. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus might make or by known or unknown risks and uncertainties, including, but not limited to the future cost, timing, enrollment and success of ongoing and planned clinical trials; the risk of demonstrating the ultimate potential of ALTU-238; the continuing risks associated with the development and manufacture of products to supply the clinical trials; the unproven safety and efficacy of ALTU-238; and limitations on the ability of Altus to advance the program due to the company's financial condition. Consequently, no forward-looking statement can be guaranteed, and actual results may differ materially from those expressed or implied by any such forward-looking statement. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus' reports to the Securities and Exchange Commission, including in Item 1A "Risk Factors" in its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2009. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. |
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