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Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function Results Validate Primary Efficacy Endpoint Achieve

Key Takeaway: Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function Results Validate Primary Efficacy Endpoint Achieved in Previous Successfully Completed Phase III Clinical

Full Press Release Details

Kitov Pharmaceuticals Announces Phase III/IV
Clinical Trial for KIT-302
Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function
Results Validate Primary Efficacy Endpoint
Achieved in Previous Successfully Completed Phase III Clinical Trial
KIT-302 Reduces Creatinine Levels Indicating
Improved Renal Function, Compared to Negative Effects of other NSAIDs
Company Recently Submitted, and FDA Accepted
for Filing, NDA for KIT-302 for Simultaneous Treatment of Osteoarthritis
Pain and Hypertension
Tel Aviv, Israel, October 26, 2017 -
Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that its randomized
double-blind, placebo-controlled renal function clinical trial for its lead drug candidate, KIT-302, successfully met its primary
efficacy endpoint. Data from the trial demonstrated that KIT-302 lowered systolic blood pressure a comparable amount to the widely
used antihypertension drug, amlodipine besylate, thus meeting the trial's primary efficacy endpoint of achieving at least
50% of the amlodipine reduction (p=0.019).
KIT-302, a combination drug, simultaneously treats pain caused by osteoarthritis and treats hypertension,
which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs,
celecoxib (Celebrex ) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc ). The renal
function study enrolled 104 patients randomized to three treatment groups: KIT-302, amlodipine besylate, and placebo. The primary
efficacy endpoint of the trial was to show that KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction
in blood pressure achieved in patients treated with amlodipine besylate only. Secondary endpoints included various parameters of
The study also demonstrated that treatment
with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value
(p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.
When comparing the effect of KIT-302 to
amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over
that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment
arm. Both this creatinine measure and the edema measure were statistically insignificant.
Kitov submitted its New Drug Application
(NDA) for marketing approval of KIT-302 to the U.S. Food and Drug Administration (FDA) in July 2017, and in September 2017, FDA
filed the NDA, thereby granting a full review. Although the renal clinical trial was not required as part of the initial KIT-302
NDA submission, the Company anticipates completion and submission of the report to FDA by January 2018.
"We are very pleased with the results
of our renal function clinical trial and look forward to submitting the related clinical study report to FDA. Although FDA has
publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor
and angiotensin receptor blocker classes, this study once again demonstrated that our combination lacks the toxicities of these
other classes and combinations. This makes our combination uniquely suited for the millions of Americans with both osteoarthritis
and hypertension. The reduction of creatinine levels by KIT-302, indicating improved renal function, as compared to the negative
effects on renal function of other NSAIDs, further demonstrates the value of KIT-302," said Dr. J. Paul Waymack, Chairman
of Kitov's Board and Chief Medical Officer.
Kitov Pharmaceuticals (NASDAQ: KTOV, TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep
regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record in streamlined
end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and
hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. Kitov's newest drug, NT219,
which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy,
and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various
cancer models. By lowering development risk and cost through fast-track regulatory approval of novel 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.
Statements and Kitov's Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified
by the use of forward-looking 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 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, 2016 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.gov
For further information, contact:
Chief Financial Officer
+972-3-9333-121 ext. #105
LifeSci Advisors, LLC
Last updated: Oct 26, 2017