Kitov Successfully Completes IND-enabling Studies to advance NT219 for the Treatment of Patients with Recurrent or Metastatic...
27 Junho 2019 - 8:30AM
Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a pharmaceutical
company focused on advancing first-in-class oncology therapies to
overcome tumor drug resistance, increase treatment response rate,
and slow tumor progression, today announced that it has
successfully completed the laboratory phase of the IND-enabling
studies for NT219, a first-in-class, dual-inhibitor small molecule,
designed to prevent and overcome cancer drug resistance. The
preclinical GLP toxicology studies have demonstrated good
tolerability at the highest dose levels expected to be tested in
Kitov’s planned Phase 1/2 study treating patients with
squamous cell carcinoma of the head and neck (SCCHN).
“We are excited with the completion of the IND-enabling studies
for NT219 which advances our growing oncology pipeline to the
clinic,” stated Isaac Israel, chief executive officer of Kitov.
“Our planned development of NT219 is based on strong preclinical
evidence demonstrating that the combination of NT219 with the EGFR
antibody cetuximab has potential clinical benefits for patients
with recurrent or metastatic SCCHN whose cancer has not responded
or has become resistant to early-line immuno-oncology or
chemotherapy treatments. Pending a smooth regulatory review
process, we look forward to initiating a Phase 1/2 trial with NT219
and cetuximab in the U.S. by the end of 2019.”
Kitov is preparing for completion of the GMP manufacturing of
the drug product and submission of an investigational new drug
(IND) application with the U.S. Food and Drug Administration (FDA)
to initiate a dose-escalation Phase 1/2 study to treat SCCHN cancer
patients with the combination of NT219 and cetuximab.
About NT-219
NT219, is a first-in-class small molecule
designed to prevent and overcome cancer drug resistance. NT-219 is
an inhibitor of two signaling proteins involved in drug resistance,
Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer
and Activator of Transcription 3 (STAT3). Efficacy of NT-219 was
demonstrated in PDX models in combination with targeted therapies,
chemotherapies and immuno-oncology therapies in delaying onset and
reversing resistance to anti-cancer drugs in head and neck, colon,
lung, and pancreatic cancers. Kitov is planning to initiate a Phase
1/2 open label multi-center study of NT-219 in combination with
cetuximab (ErbituxTM) in patients with recurrent or metastatic
squamous cell carcinoma of the head and neck (SCCHN) by the end of
2019.
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE:
KTOV) is advancing first-in-class oncology therapies to overcome
tumor drug resistance, increase treatment response rate, and slow
tumor progression. Kitov’s oncology pipeline includes NT219 a small
molecule targeting novel cancer drug resistance pathways and Kitov
is under contract to acquire 100% of FameWave Ltd. which owns
CM-24, a humanized monoclonal antibody directed against
carcinoembryonic antigen-related cell adhesion molecule 1
(CEACAM1), an immune checkpoint protein belonging to the Human CEA
(Carcino-Embryonic Antigen) protein family. CM-24 is being
developed for multiple oncological indications according to the
expression pattern of its target protein. Following the recent
receipt of the approval of Kitov’s shareholders for the acquisition
of FameWave, and the finalization of a clinical collaboration
agreement between FameWave and Bristol Myers Squibb (NYSE:BMY) for
their planned Phase 1/2 clinical trials to evaluate the combination
of CM-24 with nivolumab (Opdivo®), a PD-1 inhibitor, the
acquisition is expected to close during the third quarter of 2019,
subject to fulfillment of certain additional closing conditions. In
addition, Kitov’s combination drug, Consensi™, treating
osteoarthritis pain and hypertension simultaneously, was approved
by the FDA for marketing in the U.S and is partnered in the U.S,
China and South Korea.
By lowering development risk and cost through
fast-track regulatory approval of novel late-stage therapeutics,
Kitov plans to deliver rapid ROI and long-term potential to
investors, while making a meaningful impact on people’s lives. For
more information on Kitov, the content of which is not part of this
press release, please visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's
Safe Harbor Statement
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements that are not statements of historical fact, and may be
identified by words such as “believe”, “expect”, “intend”, “plan”,
“may”, “should”, “could”, “might”, “seek”, “target”, “will”,
“project”, “forecast”, “continue” or “anticipate” or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. You should not place undue reliance on these
forward-looking statements, which are not guarantees of future
performance. Forward-looking statements reflect our current views,
expectations, beliefs or intentions with respect to future events,
and are subject to a number of assumptions, involve known and
unknown risks, many of which are beyond our control, as well as
uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
or contribute to such differences include, among others, risks
relating to: the manner in which the parties to the transaction for
the acquisition of FameWave by Kitov plan to effect the
transaction; the expected benefits, synergies and costs of the
transaction; management plans relating to the transaction; the
expected timing of the completion of the transaction; the parties’
ability to complete the transaction considering the various closing
conditions; the plans, strategies and objectives of management for
future operations; product development for NT219 and CM-24; the
potential future financial impact of the transaction; and any
assumptions underlying any of the foregoing; the process by which
early stage products such as CM-24 could potentially lead to
an approved product is long and subject to highly significant
risks, particularly with respect to a joint development
collaboration; the fact that drug development and commercialization
involves a lengthy and expensive process with uncertain outcomes;
our ability to successfully develop and commercialize our
pharmaceutical products; the expense, length, progress and results
of any clinical trials; the lack of sufficient funding to finance
the clinical trials; the impact of any changes in regulation and
legislation that could affect the pharmaceutical industry; the
difficulty in receiving the regulatory approvals necessary in order
to commercialize our products; the difficulty of predicting actions
of the U.S. Food and Drug Administration or any other applicable
regulator of pharmaceutical products; the regulatory environment
and changes in the health policies and regimes in the countries in
which we operate; the uncertainty surrounding the actual market
reception to our pharmaceutical products once cleared for marketing
in a particular market; the introduction of competing products;
patents attained by competitors; dependence on the effectiveness of
our patents and other protections for innovative products; our
ability to obtain, maintain and defend issued patents with
protective claims; the commencement of any patent interference or
infringement action; our ability to prevail, obtain a favorable
decision or recover damages in any such action; and the exposure to
litigation, including patent litigation, and/or regulatory actions;
the uncertainty surrounding an investigation by the Israel
Securities Authority into our historical public disclosures and the
potential impact of such investigation on the trading of our
securities or on our clinical, commercial and other business
relationships, or on receiving the regulatory approvals necessary
in order to commercialize our products, and other factors that are
discussed in our in our Annual Report on Form 20-F for the year
ended December 31, 2018 and in our other filings with the SEC,
including our cautionary discussion of risks and uncertainties
under ‘Risk Factors’ in our Registration Statements and Annual
Reports. These are factors that we believe could cause our actual
results to differ materially from expected results. Other factors
besides those we have listed could also adversely affect us. Any
forward-looking statement in this press release speaks only as of
the date which it is made. We disclaim any intention or obligation
to publicly update or revise any forward-looking statement, or
other information contained herein, whether as a result of new
information, future events or otherwise, except as required by
applicable law. You are advised, however, to consult any additional
disclosures we make in our reports to the SEC, which are available
on the SEC’s website, http://www.sec.govFor further information,
contact: Gil Efron Deputy CEO & Chief Financial
Officer +972-3-933-3121 ext. #105
IR@kitovpharma.com
Media Inquiries:
Darren Opland, Ph.D.
darren@lifescipublicrelations.com
+1 646 627 8387
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