Auven Therapeutics, the global private equity company focused on
accelerated development of breakthrough therapeutic drugs and
Bellus Health Inc. (TSX: BLU), a drug development company focused
on rare diseases, today announced that Auven has entered into a
license agreement with the Icahn School of Medicine at Mount Sinai
in New York, under which Auven obtains rights to develop KIACTA™
(eprodisate) as a treatment for chronic sarcoidosis.
Auven intends to conduct a Phase II (proof-of-concept) clinical
trial to evaluate KIACTA™’s effectiveness and safety to treat
certain medical manifestations of sarcoidosis. KIACTA™ is
aimed at addressing the disease process (i.e. pathophysiology) in
sarcoidosis patients.
Auven expects to finalize a study protocol by mid-year and
anticipates that the trial will start dosing patients in the fourth
quarter of 2014. The Phase II trial is expected to be completed
within approximately 18 months of the time the first patient is
enrolled.
The idea to use KIACTA™ as a treatment for chronic sarcoidosis
was developed by Adam S. Morgenthau, MD, Assistant Professor of
Medicine at the Icahn School of Medicine at Mount Sinai. Dr.
Morgenthau is the director of the Sarcoidosis Clinic at Mount
Sinai, one of the largest centers of its kind in the U.S., and
which specializes in treating patients with complex cases of
sarcoidosis. “KIACTA™’s mechanism of action, and its benign safety
profile demonstrated to date, make it an attractive clinical
candidate for a proof-of-concept study in patients with chronic
sarcoidosis, a disease whose current treatments may cause
debilitating long-term side effects,” said Dr. Morgenthau.
Sarcoidosis is a rare condition that causes small patches
of red and swollen tissue - called granulomas - that can develop in
multiple organs in the body, but mostly in the lungs and skin. The
disease affects approximately 120,000 patients in the US alone and
identification of an effective treatment is a major unmet medical
need. While acute sarcoidosis can improve on its own, chronic
sarcoidosis can cause scarring to the lungs and decreased lung
function over time, potentially affecting other areas of the body,
including the liver.
“There is no cure for sarcoidosis, and treatment options are
limited and can have serious adverse effects” said Dr. Peter B.
Corr, Co-Founder and Managing General Partner of Auven
Therapeutics. “Obtaining the rights to move KIACTA™ into a second
indication further expands its commercial potential and may help
patients with this sometimes debilitating chronic disease” he
added.
KIACTA™ is an orally bioavailable small molecule, currently
being investigated in a Phase III pivotal study in patients with AA
Amyloidosis, an orphan indication that results from long-standing
inflammatory conditions. Auven Therapeutics acquired worldwide
rights related to KIACTA™ from Bellus Health in 2010 and assumed
control of the KIACTA™ development program and related activities,
including the Phase III clinical study in AA Amyloidosis.
The agreement was negotiated through Mount Sinai Innovation
Partners which facilitates the real-world application and
commercialization of Mount Sinai discoveries and the development of
research partnerships with industry.
Notes to Editors
About Auven Therapeutics
(www.auventx.com)
Auven Therapeutics is a global private equity firm that acquires
and pursues accelerated development of breakthrough therapeutic
drugs prior to licensing them to commercial partners. Auven’s
in-house team of senior pharmaceutical development executives
establish the clinical, regulatory, manufacturing and commercial
strategies for all its products and oversees their execution. Auven
was founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr,
and maintains operations in Lausanne, London, New York, Bermuda,
and the U.S. Virgin Islands.
About BELLUS Health
(www.bellushealth.com)
BELLUS Health is a drug development company focused on rare
diseases. It has a portfolio of rare disease projects including
KIACTA™ in phase III for AA amyloidosis, clinical stage ShigamabTM
for STEC-related Hemolytic Uremic Syndrome (sHUS) and a
research-stage project for AL amyloidosis. The lead program KIACTA™
is currently in a Phase III Confirmatory Study for the treatment of
AA amyloidosis, an orphan indication resulting in renal dysfunction
that often rapidly leads to dialysis and death.
About the Sarcoidosis Program at Mount Sinai:
(http://www.mountsinai.org/patient-care/service-areas/lung-diseases-and-surgery/areas-of-care/sarcoidosis-program/what-is-sarcoidosis)
Since its establishment by Louis Siltzbach, MD, in 1948, Mt.
Sinai's Sarcoidosis Program has grown to become the largest in the
world, with more than 18,000 patients enrolled to date, and
approximately 40 more coming to the Sarcoidosis Clinic each week.
Because sarcoidosis is a multi-organ disease, the Sarcoidosis
Clinic offers expertise in all aspects of the condition with the
help of a multidisciplinary team. Sarcoidosis is a challenging
disease in which patients can struggle for years with ineffective
treatments and unanswered questions. To meet the need for
treatment, Mount Sinai has brought a team of experts together to
form an unparalleled sarcoidosis service that combines all the
medical skills and resources patients need to manage every aspect
of this condition.
About Sarcoidosis
Sarcoidosis is a systemic granulomatous disease of uncertain
etiology that affects men and women of all races and ages
worldwide. Sarcoidosis is characterized by abnormal masses or lumps
(called granulomas) consisting of inflamed tissues that can develop
in any part of the body, but are most commonly found in the lymph
glands, lungs and skin. These granulomas may alter the normal
structure and the function of the affected organ(s) and can also
affect the heart, nervous system, liver, spleen, muscles, nose,
sinuses or eyes Sarcoidosis has a variable clinical presentation
and course. Most patients with sarcoidosis recover, but
approximately 30% develop chronic, debilitating disease. Mortality
occurs in 1-5% of patients. Lung fibrosis is the most common cause
of death. Evidence suggests that chronic granulomatous inflammation
leads to fibrosis. Corticosteroids, the mainstay of therapy in
sarcoidosis, nonspecifically suppress chronic granulomatous
inflammation, often causing debilitating adverse effects but do not
correct the underlying disease. Specific therapies for the
treatment of chronic granulomatous inflammation are needed.
About KIACTA for AA Amyloidosis
KIACTA™(eprodisate) is an orally bioavailable small molecule
intended for the treatment of AA amyloidosis, an orphan indication
that often rapidly leads to dialysis and death due to end stage
renal disease. Auven Therapeutics and BELLUS Health are partners in
the development of KIACTA™. Auven Therapeutics is responsible for
conducting and paying for the currently ongoing Phase III
Confirmatory Study. Patient recruitment is ongoing and is expected
to be completed in the second quarter of 2014. The Phase III
Confirmatory Study is an event driven trial that is expected to
conclude in 2016. The study will be used to confirm the positive
safety and efficacy results shown in the Phase II/III study
previously conducted by BELLUS Health.
Forward Looking Statements
Certain statements contained in this news release, other than
statements of fact that are independently verifiable at the date
hereof, may constitute forward-looking statements. Such statements,
based as they are on the current expectations of management,
inherently involve numerous risks and uncertainties, known and
unknown, many of which are beyond BELLUS Health Inc.'s and Auven
Therapeutics’ control. Such risks include but are not limited to:
the ability to obtain financing immediately in current markets, the
impact of general economic conditions, general conditions in the
pharmaceutical and/or nutraceutical industry, changes in the
regulatory environment in the jurisdictions in which BELLUS Health
Inc. and Auven Therapeutics do business, stock market volatility,
fluctuations in costs, and changes to the competitive environment
due to consolidation, achievement of forecasted burn rate,
achievement of forecasted clinical trial milestones, and that
actual results may vary once the final and quality-controlled
verification of data and analyses has been completed. The length of
KIACTATM Phase III Confirmatory Study is dependent upon many
factors including clinical sites activation, patients enrollment
rate, patients drop-out rate and occurrence of worsening events.
Consequently, actual future results may differ materially from the
anticipated results expressed in the forward-looking statements.
The reader should not place undue reliance, if any, on any
forward-looking statements included in this news release. These
statements speak only as of the date made and BELLUS Health Inc.
and Auven Therapeutics are under no obligation and disavow any
intention to update or revise such statements as a result of any
event, circumstances or otherwise, unless required by applicable
legislation or regulation. Please see BELLUS’’ public fillings
including the Annual Information Form of BELLUS Health Inc. for
further risk factors that might affect the BELLUS and its
business.
For more information please contact:Media
enquiries:Instinctif PartnersSue Charles/Stefanie Bacher/Gemma
HoweT: +44 (0)20 7866 7866auventx@instinctif.comorAuven
Therapeutics:Investor RelationsKathy Armstrong:T: +1 (212) 616
4042kathy_armstrong@auventx.comorBELLUS Health:Adam
PeelerTMX EquicomT: +1 416-815-0700 ext.
225apeeler@tmxequicom.com
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