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Altus Pharmaceuticals Announces Completion of Clinical Testing in the Phase I Study of ALTU-238 - a Long-Acting Crystalline Formulation of Human Growth Hormone

Posted on: Monday, 6 June 2005, 09:00 CDT

Plans to Initiate Phase II Multi-Center Trial in Adults with Growth Hormone Deficiency

Altus(R) Pharmaceuticals Inc., a leader in the development of novel protein therapies to treat chronic gastrointestinal and metabolic diseases, announced today that it has successfully completed clinical testing in the Phase I study for ALTU-238, a long-acting crystalline formulation of recombinant human growth hormone (somatropin). The study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of ALTU-238 in normal healthy volunteers. The Company also announced it plans to initiate a multi-center Phase II clinical trial to study the safety and biological activity of repeated doses of ALTU-238 in adults with growth hormone deficiency.

Sheldon Berkle, President and Chief Executive Officer of Altus Pharmaceuticals said, "We believe that ALTU-238 will provide patients with a long-acting treatment option that has comparable efficacy and safety to existing therapies, but with fewer injections, less discomfort, and improved compliance." Mr. Berkle continued, "The application of the Company's proprietary technology to orally administered proteins has already been demonstrated by TheraCLEC-Total(TM), which has recently completed a multi-center, randomized, double-blind Phase II trial for pancreatic insufficiency, the largest prospective study of its kind yet performed. This Phase I trial of ALTU-238 is expected to confirm in humans the value of our proprietary crystallization technology by extending the release and improving the stability of injectable protein therapeutics."

ALTU-238 is a novel, long-acting subcutaneous formulation of recombinant human growth hormone that employs Altus' proprietary protein crystallization and formulation technology. Altus' technology preserves the structure of the human growth hormone molecule without the need for polymers or encapsulation and enables ease of administration through a fine gauge needle. Recombinant human growth hormone is approved for treating multiple growth disorders in children, adolescents and adults. Global sales of recombinant human growth hormone were approximately $2.2 billion USD in 2004.

"Upon completion of this Phase I study we believe that we will have the safety, dosing and biological activity data needed to advance ALTU-238 into the next phase of clinical trials in patients with growth hormone disorders. The results of our preclinical studies, which were presented at the 87th Annual Endocrine Society Meeting in San Diego, CA, demonstrated that ALTU-238, delivered with a fine 30 gauge needle, results in hGH bioavailability that is capable of stimulating the production of IGF-1 levels to the normal range in a dose-dependent manner consistent with a once-weekly product," said Dr. Alexey Margolin, Chief Scientific Officer at Altus Pharmaceuticals. "In contrast to the current standard of daily injections, we believe that a long-acting formulation of human growth hormone, like ALTU-238, has the potential to offer people with growth hormone disorders a more convenient treatment with improved effective disease management."

About Growth Hormone Deficiency and Growth Failure

Growth hormone disorders occur when the production of growth hormone, secreted via the hypothalamic -pituitary axis (GHRH-GH-IGF1), is disrupted. Growth hormone plays a critical role in stimulating bone growth and development and it is involved in the production of muscle and in the breakdown of fats. Pediatric growth hormone deficiency affects an estimated 20,000 to 30,000 patients in the U.S. and approximately 50,000 people in Europe and Japan. In children, when there is a complete absence of growth hormone, severe growth retardation results. When there is a partial deficiency of growth hormone in children, short stature results. Adult growth hormone deficiency affects approximately 70,000 adults in the U.S. Currently, it is estimated that only up to 15 percent of diagnosed adults receive treatment, in part because of the burden of daily injections. Recombinant human growth hormone (rhGH) products are currently approved to treat multiple growth disorders, including pediatric and adult growth hormone deficiency, Turner Syndrome, chronic renal insufficiency, idiopathic short stature, Prader-Willi Syndrome, short bowel syndrome and muscle wasting in patients with HIV.

About Altus Pharmaceuticals

Altus Pharmaceuticals is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases. Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally delivered and injectable protein replacement products. As a company, Altus is committed to improving the quality of life of patients. More information about Altus and its clinical development programs can be found at www.altus.com.

Source: Business Wire

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