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Here is some info on ALTU-238. Alot of the info is repetitive but you get the idea.
ALTU-238
ALTU-238 is a crystallized formulation of hGH that is designed to be administered once weekly through a fine gauge needle for the treatment of hGH disorders in both pediatric and adult populations. Pediatric growth hormone deficiency affects approximately 1 in 3,500 children and 1 in 10,000 adults. The market for hGH was approximately $2.2 billion in 2004. Secondary indications may include small for gestational age, idiopathic short stature, Turner Syndrome, HIV-AIDS, Prader-Willi Syndrome, and short bowel syndrome.
ALTU-238 is a long-acting formulation that will be designed to require fewer injections without the use of polymers or fusion proteins; a significant improvement in development. There are currently 8 FDA-approved human growth products on the market in the U.S. All the products on the market are essentially identical and are differentiated solely through variations in their respective delivery devices and formulations. ALTU-238 has completed a Phase I clinical trial in healthy adults and we recently initiated a Phase II clinical trial in adults with growth hormone deficiency.
News Release
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. – November 13, 2006 - 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.
Page 2
ALTU-238 Phase II at International Congress GRS and IGF/2
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
Altus Pharmaceuticals.
Page 3
ALTU-238 Phase II at International Congress GRS and IGF/2
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.
ALTU-238
ALTU-238 is a crystallized formulation of hGH that is designed to be administered once weekly through a fine gauge needle for the treatment of hGH disorders in both pediatric and adult populations. Pediatric growth hormone deficiency affects approximately 1 in 3,500 children and 1 in 10,000 adults. The market for hGH was approximately $2.2 billion in 2004. Secondary indications may include small for gestational age, idiopathic short stature, Turner Syndrome, HIV-AIDS, Prader-Willi Syndrome, and short bowel syndrome.
ALTU-238 is a long-acting formulation that will be designed to require fewer injections without the use of polymers or fusion proteins; a significant improvement in development. There are currently 8 FDA-approved human growth products on the market in the U.S. All the products on the market are essentially identical and are differentiated solely through variations in their respective delivery devices and formulations. ALTU-238 has completed a Phase I clinical trial in healthy adults and we recently initiated a Phase II clinical trial in adults with growth hormone deficiency.
News Release
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. – November 13, 2006 - 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.
Page 2
ALTU-238 Phase II at International Congress GRS and IGF/2
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
Altus Pharmaceuticals.
Page 3
ALTU-238 Phase II at International Congress GRS and IGF/2
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.
