Ketamir-2, the Company's novel oral ketamine
analog in development, aims to provide a safe and effective
alternative for managing cancer pain and associated
depression
MIAMI, May 21, 2024
/PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ:
MIRA) ("MIRA" or the "Company"), a pre-clinical-stage
pharmaceutical company focused on the treatment of neurologic and
neuropsychiatric disorders, announced it is in advanced discussions
with Memorial Sloan Kettering Cancer Center (MSK) to initiate a
preclinical study evaluating MIRA's novel oral ketamine analog,
Ketamir-2, for the treatment of cancer-related pain and
depression.
MIRA Pharmaceuticals in Discussions with
Memorial Sloan Kettering to Collaborate on Preclinical Cancer Pain
Model
This collaboration with MSK, one of the top cancer centers in
the world, would represent an important validation of the potential
for Ketamir-2. This underscores MIRA's commitment to broadening the
potential uses of its novel compound beyond treatment-resistant
depression, major depressive disorder, and post-traumatic stress
disorder, which MIRA is already studying in a preclinical
setting.
Currently, MSK treats pain in patients with refractory cancer
(meaning cancer that has not responded to initial treatment or is
getting worse) using intravenous (IV) ketamine, among other
methods. However, MIRA's novel oral ketamine analog presents a
promising alternative due to its potential for high oral
bioavailability and lack of interaction with mu opioid receptors,
which potentially enhances its safety profile. Oral
administration is more convenient and less invasive than IV
treatments and would potentially enable in-house treatment, as
opposed to the current method of in-hospital treatment. The aim of
this collaboration would be to assess the potential of oral
Ketamir-2, in comparison with non-oral administration of ketamine,
to alleviate symptoms of cancer pain in a rodent animal
model. In parallel, MIRA is exploring the effects of
Ketamire-2 on neuropathic pain within the framework of its
collaboration with Pharmaseed Ltd.
"We view a proposed partnership with Memorial Sloan Kettering as
immensely validating of our efforts to develop Ketamir-2. Our
groundbreaking oral ketamine analog not only offers patients a
potentially safer and more convenient treatment option but also
holds tremendous potential to disrupt the oncology pain market as
well as the other potential uses we are currently exploring.
This collaboration underscores our commitment to innovation
and improving patient outcomes" said Erez
Aminov, Chairman & CEO of MIRA
Pharmaceuticals.
"While opioid therapy is still used as the standard of care for
management of cancer pain, multimodal treatment options are needed
to reduce the risk of opioid tolerance, abuse and divergence.
Clinically, the potential for ketamine-like and cannabinoids
for the treatment of cancer pain has been very promising. Our
experience at Memorial Sloan Kettering Cancer Center with
intravenous ketamine and cannabinoids further support development
for oral medications with a favorable safety profile for the
treatment of cancer pain. We are excited about the potential
treatment options presented by MIRA, Ketamir-2 and Mira-55. These
compounds should improve the lives of our cancer pain patients"
said Dr. Amitabh Gulati, Director
Chronic Pain, Memorial Sloan Kettering and Board Member of Cancer
Pain Research Consortium.
The novel oral ketamine analog developed by MIRA aims to provide
a safe and effective alternative for managing cancer pain and
associated depression. This therapeutic could potentially
streamline the regulatory approval process by leveraging its novel
properties, allowing for an accelerated clinical studies as
combined Phase 1/2 clinical trial. Successful outcomes from the
preclinical study could potentially accelerate the pathway for U.S.
Food and Drug Administration approval of an Investigational New
Drug Application for Ketamir-2 over the next year and open
opportunities for non-dilutive funding, enhancing MIRA's capacity
to deliver groundbreaking treatments to needy patients in the
future.
"As we seek to join forces with Memorial Sloan Kettering, we are
aiming to redefine the standard of care in cancer pain management.
Our novel oral ketamine analog shows great potential in offering
patients safer and more accessible treatment options, including the
ability to treat depression, which is common among cancer patients.
This collaboration marks a significant step forward in our mission
to transform the landscape of oncology therapeutics" said Dr.
Itzchak Angel, Chief Scientific
Advisor to MIRA Pharmaceuticals.
Cancer Pain Market
Cancer pain is a significant and pervasive issue among cancer
patients. Research indicates that approximately 44% of cancer
patients experience pain, with about 31% enduring moderate to
severe pain1. This prevalence is consistent across
multiple studies, including a 2023 review of over 10,000 studies
and a 2021 systematic review of research conducted between 2014 and
20212 3. Additionally, the National Cancer Institute
reports that around 25% of cancer patients suffer from depression,
a rate substantially higher than the general
population4.
About MIRA Pharmaceuticals
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a
pre-clinical-stage pharmaceutical development company with two
neuroscience programs targeting a broad range of neurologic and
neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian
and Mexican rights for Ketamir-2, a novel, patent-pending oral
ketamine analog under investigation to potentially deliver
ultra-rapid antidepressant effects, providing hope for individuals
battling treatment-resistant depression, major depressive disorder
with suicidal ideation and post-traumatic stress disorder. The U.S.
Drug Enforcement Administration's scientific review of Ketamir-2
concluded that it would not be considered a controlled substance or
listed chemical under the Controlled Substances Act and its
governing regulations.
In addition, MIRA's novel oral pharmaceutical marijuana,
MIRA-55, is currently under investigation for treating adult
patients suffering from anxiety and cognitive decline, often
associated with early-stage dementia. MIRA-55, if approved by the
FDA, could mark a significant advancement in addressing various
neuropsychiatric, inflammatory, and neurologic diseases and
disorders.
Additional information about the Company is available at
www.mirapharmaceuticals.com.
Ketamir-2 and MIRA-55 are in early-stage preclinical
development. There is no assurance that the products will proceed
through development or receive FDA approval for marketing.
About Memorial Sloan Kettering Cancer Center
The people of Memorial Sloan Kettering Cancer Center
(MSK) are united by a singular mission: ending cancer for
life. Our specialized care teams provide personalized,
compassionate, expert care to patients of all ages. Informed by
basic research done at our Sloan Kettering Institute, scientists
across MSK collaborate to conduct innovative translational and
clinical research that is driving a revolution in our understanding
of cancer as a disease and improving the ability to prevent,
diagnose, and treat it. MSK is dedicated to training the
next generation of scientists and clinicians who go on to pursue
our mission at MSK and around the globe. One of the world's most
respected comprehensive centers devoted exclusively to cancer, we
have been recognized as one of the top two cancer hospitals in the
country by U.S. News & World Report for more than 30 years.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of the Company's
management related thereto contains "forward-looking statements,"
which are statements other than historical facts made pursuant to
the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. These statements may be identified by words such
as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans,"
"possible," "potential," "seeks," "will," and variations of these
words or similar expressions that are intended to identify
forward-looking statements. Any statements in this press
release that are not historical facts may be deemed
forward-looking. These forward-looking statements include, without
limitation, statements regarding the potential for the Company's
collaboration with MSK (which are not finalized and might not
occur) and statements regarding the timing for the Company's
preclinical studies and the filing of an IND for Ketamir-2.
Any forward-looking statements in this press release are based on
the Company's current expectations, estimates and projections only
as of the date of this release and are subject to a number of risks
and uncertainties (many of which are beyond the Company's control)
that could cause actual results to differ materially and adversely
from those set forth in or implied by such forward-looking
statements. These and other risks concerning the Company's programs
and operations are described in additional detail in Annual Report
on Form 10-K for the year ended December 31,
2023 and other SEC filings, which are on file with the SEC
at www.sec.gov and the Company's website
at https://www.mirapharmaceuticals.com/investors/sec-filings.
The Company explicitly disclaims any obligation to update any
forward-looking statements except to the extent required by
law.
1 Fightcancer.org – Cancer Pain Statistics
2 2023 Systematic Review on Cancer Pain
3 2021 Review of Studies on Cancer Pain
(2014-2021)
4 National Cancer Institute – Depression in Cancer
Patients
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SOURCE MIRA Pharmaceuticals, Inc.