Cotinga Pharmaceuticals Announces Initiation of Next Cohort of Phase 1b/2a Combination Trial of COTI-2 in Solid Tumors
05 Juin 2019 - 6:42PM
Cotinga Pharmaceuticals Inc. (TSX Venture: COT) (“Cotinga”
or the “Company”), a clinical-stage pharmaceutical company
advancing a pipeline of targeted therapies for the treatment of
cancer, announced today that the Company has initiated the third
cohort of its ongoing Phase 1b/2a clinical trial of COTI-2 plus
cisplatin in solid tumors. The objective of the third cohort is to
continue to evaluate the safety and tolerability of COTI-2 in
combination with standard-of-care cisplatin.
“We are pleased to report that the DEC voted
unanimously to continue dose escalation in our combination trial,
with the new dosage level of 1.7 mg/kg, an increase from the 1.0
mg/kg level of cohort 2”, said Alison Silva, Cotinga’s President
& CEO. “We are pleased with the Committee’s recommendation and
trial advancement. The patients in our ongoing Phase 1b/2a trial
are suffering from a wide spectrum of cancers with little to no
therapeutic options, and we are hopeful that combining existing
chemotherapy regimens with COTI-2 could be a potential treatment as
we have demonstrated and published in a number of preclinical
studies. We remain committed to advancing the clinical development
of COTI-2, and we will continue to provide key updates as the trial
progresses.”
Phase 1b/2a Trial of COTI-2
The ongoing trial of COTI-2 will focus on
evaluating COTI-2 as a combination therapy for the potential
treatment of a wider range of cancers. In 2017, the Company
announced top-line data from the gynecological malignancies arm of
the trial demonstrating monotherapy with COTI-2 was generally safe
and well-tolerated. Monotherapy with COTI-2 also exhibited an
encouraging pharmacokinetic/pharmacodynamic profile and signals of
efficacy.
The current protocol amendment being implemented
by the Company in May 2018 expands the ongoing trial to evaluate
COTI-2 in combination with various standard-of-care chemotherapy
regimens in a wide spectrum of cancers.
This protocol amendment evaluates COTI-2
combined with standard-of-care cisplatin in up to 30 patients with
any of the following malignancies: ovarian, fallopian tube, primary
peritoneal, endometrial, cervical, lung, pancreatic or colorectal
cancer, or head and neck squamous cell carcinoma. Patients in this
dose finding study will be given a 60 mg/m2 IV dose of cisplatin
every three weeks in combination with an oral dose of COTI-2 five
days per week. Up to five COTI-2 dose levels will be evaluated
ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will
occur every six weeks. Primary outcome measures will evaluate
safety and tolerability and determine the maximum tolerated dose
and recommended Phase 2 dose for COTI-2 as a combination therapy.
Secondary and exploratory outcome measures will evaluate
pharmacokinetics and various signals of efficacy. Additional
details on the protocol amendment are available on
clinicaltrials.gov.
About Cotinga Pharmaceuticals
Inc.
Cotinga Pharmaceuticals is a clinical-stage
pharmaceutical company that uses proprietary artificial
intelligence technologies to pursue a targeted and transformational
approach to treating cancer and other unmet medical needs.
Cotinga’s CHEMSAS® technology is intended to accelerate the
discovery and development of novel drug therapies, allowing the
Company to build a pipeline of potential drug candidates faster and
with a higher probability of success than traditional methods.
The Company’s lead compound, COTI-2, has a novel
p53-dependent mechanism of action with selective and potent
anti-cancer activity. P53 mutations occur in over 50% of all
cancers. COTI-2 is initially being evaluated in combination
with various standard-of-care chemotherapy regimens for the
treatment of a wide spectrum of cancers in a Phase 1b/2a clinical
trial at the MD Anderson Cancer Center at the University of Texas.
The Company has secured orphan drug status in the United States for
COTI‐2 for the treatment of ovarian cancer. Preclinical data
suggests that COTI-2 could dramatically improve the treatment of
cancers with mutations in the p53 gene.
The Company’s second lead compound, COTI-219, is
a novel oral small molecule compound targeting the mutant forms of
KRAS without inhibiting normal KRAS function. KRAS mutations occur
in up to 30% of all cancers and represent a tremendous unmet
clinical need and a desirable drug target. COTI-219 is undergoing
IND-enabling studies to support a regulatory submission.
Follow @CotingaPharma on Twitter at
http://twitter.com/CotingaPharma.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
For more information, visit
http://www.cotingapharma.com/ or contact: Alison SilvaPresident and
CEOTel: 1-800-798-6860Email: asilva@cotingapharma.com
Notice to Readers:
Information contained in this press release may
contain certain statements which constitute “forward-looking
statements” as such term is defined under applicable securities
laws. Forward‐looking statements by their nature are not guarantees
of future performance and are based upon management’s current
expectations, estimates, projections and assumptions. For example,
“…we are hopeful that combining existing chemotherapy regimens with
COTI-2 could be a potential treatment...” Is a forward-looking
statement. Cotinga operates in a highly competitive environment
that involves significant risks and uncertainties, which could
cause actual results to differ materially from those anticipated in
these forward‐looking statements. Management of Cotinga considers
the assumptions on which these forward‐looking statements are based
to be reasonable, but as a result of the many risk factors,
cautions the reader that actual results could differ materially
from those expressed or implied in these forward-looking
statements. Information in this press release should be considered
accurate only as of the date of the release and may be superseded
by more recent information disclosed in later press releases,
filings with the securities regulatory authorities or otherwise.
Except as required by law, Cotinga assumes no obligation to update
forward-looking statements should circumstances or management's
expectations, estimates, projections and assumptions change.
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