Altus Pharmaceuticals Reports Dosing First Patient In A Phase 2 Trial Of ALTU-238 For Pediatric Growth Hormone Deficiency

Main Category: Pediatrics / Children's Health
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Jun 2009 - 4:00 PST

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Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced that patient dosing in its Phase 2 trial for ALTU-238 in growth hormone deficiency pediatric subjects began on June 2, 2009. ALTU-238 is a long-acting, extended-release formulation of recombinant human growth hormone (rhGH, somatropin), which is being developed utilizing Altus' proprietary protein crystallization 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, 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 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) 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 on Wednesday, June 10, 2009. The Endocrine Society's Annual Meeting (ENDO) 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 ALTU-238, a Long-Acting, 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.

Source
Altus Pharmaceuticals Inc.