SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that data from preclinical and clinical studies evaluating its
novel echinocandin antifungal CD101 will be presented at the 58th
American Society of Hematology (ASH) Annual Meeting and Exposition
taking place in San Diego from December 3-6, 2016. CD101 is Cidara’s
lead antifungal drug candidate and the only long-acting antifungal in
the echinocandin class.
“Patients with blood cancers and those undergoing transplantation are at
much higher risk for opportunistic fungal infections, often the cause of
significant morbidity and mortality,” said Jeffrey Stein, Ph.D.,
president and chief executive officer of Cidara. “We are pleased to be
sharing data at this year’s ASH meeting that demonstrate the potential
of our novel compound CD101 to treat and prevent deadly fungal
infections in blood cancer patients.”
CD101 data accepted for presentation at this year’s ASH Annual Meeting
comprise the following:
-
Two poster presentations evaluating the efficacy of CD101 for the
treatment and prevention of invasive fungal infections due to the
pathogens, Candida, Aspergillus and Pneumocystis. -
A poster presentation summarizing results from the successful Phase 1
clinical trial of CD101 IV, demonstrating the safety and
pharmacokinetics of single and multiple weekly dosing regimens.
Approximately 97,000 Americans die from hospital-related fungal
infections each year and 90 percent of these infections are caused by
two common fungi, Candida and Aspergillus. Systemic fungal
infections typically affect patients whose immune systems have been
compromised, such as patients undergoing organ or bone marrow
transplantation or chemotherapy including patients with hematologic
malignancies. Pneumocystis is another serious fungal infection
that commonly afflicts people with weakened immune systems.
“Invasive fungal infections remain a significant threat in patients with
hematological cancer and in transplant recipients. Although significant
progress has been made in diagnostics and the introduction of new
agents, significant challenges remain,” said Dimitrios P. Kontoyiannis,
M.D., of The University of Texas MD Anderson Cancer Center. “Current
antifungals have several issues with suboptimal pharmacokinetics,
frequent drug-to-drug interactions and contraindications with
chemotherapy or immunosuppressants, toxicity and suboptimal efficacy,
especially as fungal resistance is on the rise. There is an unmet need
for new antifungal therapies that are safe and effective with low
toxicity.”
Details for the Cidara ASH 2016 presentations are as follows:
Saturday, December 3 – Session 721: Clinical Allogeneic
Transplantation: Conditioning Regimens, Engraftment, and Acute
Transplant Toxicities – Poster I (5:30 p.m. – 7:30 p.m. PT, Hall GH)
-
Pharmacokinetics, Safety, and Target Attainment of Single and Multiple
Doses of CD101 IV; T Sandison, et. al. #2197
Sunday, December 4 – Session 721: Clinical Allogeneic
Transplantation: Conditioning Regimens, Engraftment, and Acute
Transplant Toxicities – Poster II (6:00 p.m. – 8:00 p.m. PT, Hall GH)
-
Efficacy of CD101, a Novel Echinocandin, in Mouse Models of
Aspergillosis and Azole-Resistant Disseminated Candidiasis; V. Ong,
et. al. #3400 -
Efficacy of CD101, a Novel Echinocandin, in Prevention of Pneumocystis
Pneumonia (PCP): Thwarting the Biphasic Life Cycle of Pneumocystis;
M. Cushion, et. al. #3396
Abstracts can be found at www.hematology.org
and copies of these poster presentations will also be available on the
Cidara website following the meeting: http://www.Cidara.com/
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on developing
new anti-infectives that have the potential to transform the standard of
care and save or improve patients’ lives. The company is currently
advancing its novel echinocandin antifungal, CD101, through Phase 2
studies in two indications and developing CD201, its bispecific
antimicrobial immunotherapy, for the treatment of multi-drug resistant
bacterial infections. CD101 IV has enhanced potency and is the only
once-weekly therapy intended for the treatment and prevention of
life-threatening invasive fungal infections. CD101 topical is the first
and only agent of its class being studied for the treatment and
prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal
infection. CD201 is the first drug candidate selected from Cidara’s
novel Cloudbreak™ platform, the first immunotherapy discovery platform
designed specifically to create compounds that direct a patient’s immune
cells to attack and eliminate bacterial, fungal or viral pathogens.
Cidara is headquartered in San Diego, California. For more information,
please visit www.cidara.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding the effectiveness, safety, long-acting nature,
anticipated human dosing and other attributes of CD101, and its
potential to treat infections, including infections associated with
hematologic malignancies and transplantation. Risks that contribute to
the uncertain nature of the forward-looking statements include: the
success and timing of Cidara’s preclinical studies and clinical trials;
regulatory developments in the United States and foreign countries;
changes in Cidara’s plans to develop and commercialize its product
candidates; Cidara’s ability to obtain additional financing; Cidara’s
ability to obtain and maintain intellectual property protection for its
product candidates; and the loss of key scientific or management
personnel. These and other risks and uncertainties are described more
fully in Cidara’s Form 10-Q most recently filed with the United States
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which they
were made. Cidara undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date on
which they were made.
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