Source: BUSINESS WIRE
Thursday, June 11, 2009
- - Company’s Vice President of Clinical Development To Present at
The Endocrine Society's 91st Annual Meeting - -
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WALTHAM, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU) today 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.
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 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 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 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.