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NewsBot Date: November 13, 2006 05:32:00 AM
ALTU News Altus Pharmaceuticals Announces Presentation of ALTU-238 Phase II Data at International Congress of Growth Hormone and Insulin-Like Growth Factor Research Societies
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU), a biopharmaceutical company
focused on oral and injectable protein therapeutics for patients with
gastrointestinal and metabolic disorders, announced today the
presentation of results from its Phase II study of its product candidate
ALTU-238 at The Third International Congress of the Growth Hormone
Research Society and the Insulin-like Growth Factor Research Society,
which is taking place this week in Kobe, Japan. ALTU-238 is being
developed as a subcutaneously administered, once-per-week formulation of
human growth hormone that employs Altus’
proprietary protein crystallization and formulation technology.
The results of this trial demonstrated a pharmacokinetic and
pharmacodynamic profile that the Company believes is supportive of an
ALTU-238 once-per-week dosing regimen for growth hormone deficient
adults. The study identified doses of ALTU-238 that maintained IGF-1
levels within the normal range for age and gender over the course of the
study. Once-per-week dosing of ALTU-238 appeared to result in a
consistent, linear dose response of hGH and IGF-1 levels in the blood.
Lead investigator Randall J. Urban, M.D., Chief of Medicine at The
University of Texas Medical Branch in Galveston, Texas, commented, “The
standard treatment for growth hormone deficiency typically requires
multiple injections per week, a regimen that can be inconvenient and
painful, which may lead to poor patient compliance. ALTU-238 promises to
improve patient quality of life with better dosing as a potential
once-per-week treatment, and we believe it represents a significant
milestone in the treatment of growth hormone disorders.”
The primary objectives of the trial were to determine the safety and
tolerability of ALTU-238, as well as to evaluate its pharmacokinetic and
pharmacodynamic profile. Thirteen growth hormone deficient adult
patients were randomized to receive three weekly subcutaneous
injections, using a fine 30-gauge needle, of either 5.6 mg or 11.2 mg of
ALTU-238. Pharmacokinetics and pharmacodynamics were measured for growth
hormone, insulin-like growth factor-1 (IGF-1), and bone alkaline
phosphatase (BAP) using samples taken following the first and third
subcutaneous injections. Safety assessments included fasting serum
insulin and glucose levels as well as postprandial glucose.
There were no reported serious adverse events or dropouts due to adverse
events. The most frequent adverse event reported was mild injection
pain. Typical adverse events associated with growth hormone treatment,
including myalgia, edema, and arthralgia, were uncommon. Injection site
reactions were most commonly associated with erythema, which diminished
by the third injection. No subject tested positive for anti-growth
hormone antibodies in this study.
About ALTU-238
ALTU-238 is a 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 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 $2.4 billion in 2005.
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. 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. 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 children born small for gestational age,
short bowel syndrome and muscle wasting in patients with HIV.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a
biopharmaceutical company focused on the development and
commercialization of oral and injectable protein therapeutics for
patients with gastrointestinal and metabolic disorders. The Company's
website is http://www.altus.com.
Certain statements in this news release concerning Altus' business are
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, the timing of a Phase III clinical
trial for ALTU-238, and the ability of Altus' proprietary protein
crystallization technology to effectively deliver growth hormone therapy
through a once-weekly injection using a fine gauge needle. 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 uncertainties as to the future success of ongoing and planned
clinical trials; and the unproven safety and efficacy of products under
development. Consequently, no forward-looking statement can be
guaranteed, and actual results may vary materially. 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 its Annual Report on Form 10-K for the fiscal year ended
December 31, 2005. However, Altus undertakes no obligation to publicly
update forward-looking statements, whether because of new information,
future events or otherwise.
