Perspective, Therapeutics, Inc. (formerly known as “Isoray,
Inc.”) (NYSE AMERICAN: CATX), a precision oncology company
developing alpha-particle therapies and complementary diagnostic
imaging agents and an innovator in seed brachytherapy powering
expanding treatment options for multiple cancers, announced the
presentation of extremely encouraging results regarding
212Pb-VMT-α-NET, its lead preclinical candidate for neuroendocrine
tumors (NET), currently being used therapeutically in India on a
compassionate use basis. Dr Vikas Prasad presented the results at
the 2023 PET Radiotracer Translation and Resource Center (PET-RTRC)
Workshops & Scientific Session hosted by the Mallinckrodt
Institute of Radiology (MIR) at Washington University in St. Louis.
Highlights of the presented
results include:
- The result from first patient dosed
with 212Pb-VMT-α-NET in India on a compassionate use basis showed
favorable responses after the first dose.
- The initial response was measured
by a somatostatin imaging agent 68Ga-DOTANOC and demonstrated
encouraging results after a single low dose of
212Pb-VMT-α-NET.
Dr. Prasad noted, “The patient data gathered in
the clinic under a compassionate use basis is not only remarkable
but an extremely encouraging sign for Perspective Therapeutics’
VMT-α-NET program for the treatment of neuroendocrine tumors.
Despite advancement in traditional therapies, novel approaches and
therapies are required to further increase patients’ overall
survival and improve quality of life. There is an urgent need of
bringing these kind of therapies in the first line of management of
functionally active neuroendocrine tumors.”
Dr. Vikas Prasad, MD, who is an Associate
Professor of Radiology, Mallinckrodt Institute of Radiology (MIR),
Washington University School of Medicine in St. Louis, presented
the 212Pb- VMT-α-NET results. Prior to MIR, Dr. Prasad subsequently
performed the first human images of 203Pb-VMT-α-NET while serving
as MD, Vice Chair in the Department of Nuclear Medicine at the
University Hospital of Ulm, Ulm, Germany.
"We are grateful that the science and medicine
that is in development at Perspective Therapeutics has provided a
meaningful intervention in a NET patient’s care journey. The
results give us hope that we are standing at the beginning of a new
era of precision oncology medicine. We look forward to continuing
the progress of our pipeline of targeted radiopharmaceuticals for
imaging and therapeutic use,” said Mr. Thijs Spoor, CEO of
Perspective Therapeutics.
VMT-α-NET is being developed for the treatment
and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing
neuroendocrine tumors, which are a rare and difficult-to-treat type
of cancer. The dosed patients were diagnosed with
confirmed-advanced somatostatin expressing neuroendocrine tumors
(NETs). In early December, VMT-α-NET, the Company’s lead drug for
the treatment of neuroendocrine tumors was administered to patients
in India on a compassionate use basis, independent of a planned
U.S. trial. No acute adverse reactions were observed post
administration and patients remained stable and in good
condition.
The administration of VMT-α-NET was performed
under the supervision of the patients' doctor, Dr. Ishita Sen MBBS,
DRM, DNB, Director and Head of Nuclear Medicine at Fortis Hospital,
New Delhi, in partnership with BJ Madan, a diagnostic &
therapeutic radiopharmaceutical company in New Delhi.
Radiopharmaceutical was produced (under the direction of Dr. Sen)
by Dr. Parul Thakral Dash PhD and administered following
appropriate quality control testing. Patients were imaged
immediately prior to their first therapeutic dose and immediately
prior to the second therapeutic dose. The results seen between the
1st and 2nd doses implied that the patients had a strongly
favorable response which was unexpected at such low doses of the
drug. Dr. Sen expressed her pleasure at the patients' progress and
said, "Preclinical and clinical data associated with this new
radiopharmaceutical demonstrates significant potential to help our
NET patients."
Under compassionate use circumstances, VMT-α-NET
may be made available to qualified doctors in some countries. In
this circumstance, Perspective Therapeutics (formerly Viewpoint
Molecular Targeting, Inc.) supplied drug precursors and isotopes
for the local production of its proprietary radiotherapeutic,
VMT-α-NET. The safety and effectiveness of the treatments will be
evaluated by Dr. Sen's team with laboratory testing, observation of
NET-associated symptoms, and repeat medical imaging.
In the U.S., VMT-α-NET will soon enter a Phase 1
imaging and therapy study to be conducted at various hospitals and
clinics. The administration of VMT-α-NET for compassionate use is
completely independent from and not within the scope of the
Company's Phase 1 trial.
Under compassionate use circumstances, VMT-α-NET
may be made available to qualified doctors in some countries. In
this circumstance, Viewpoint supplied drug precursors and isotopes
for the local production of its proprietary radiotherapeutic,
VMT-α-NET. The safety and effectiveness of the treatments will be
evaluated by Dr. Sen's team with laboratory testing, observation of
NET-associated symptoms, and repeat medical imaging.
In the U.S., VMT-α-NET will soon enter a Phase 1
imaging and therapy study to be conducted at various hospitals and
clinics. The administration of VMT-α-NET for compassionate use is
completely independent from and not within the scope of the
Company's Phase 1 trial.
About Perspective Therapeutics,
Inc.Perspective Therapeutics, Inc., formerly known as
Isoray, Inc., is a medical technology and radiopharmaceutical
company that is pioneering advanced treatment applications for
cancers throughout the body. The Company is the sole producer of
Cesium-131 brachytherapy seeds and has a proprietary technology
that utilizes the isotope lead-212 to deliver powerful alpha
radiation specifically to cancer cells via specialized targeting
peptides. The Company is also developing complementary imaging
diagnostics that incorporate the same targeting peptides which
provide the opportunity to personalize treatment and optimize
patient outcomes. This “theranostic” approach enables the ability
to see the specific tumor and then treat it to potentially improve
efficacy and minimize toxicity associated with many other types of
cancer treatments.
The Company’s melanoma (VMT01) and
neuroendocrine tumor (VMT-α-NET) programs are entering Phase 1/2a
imaging and therapy trials for the treatment of metastatic melanoma
and neuroendocrine tumors at several leading academic institutions.
The Company has also developed a proprietary lead-212 generator to
secure isotope supply for clinical trial and commercial operations.
For more information, please visit the Company’s website at
www.perspectivetherapeutics.com.
Safe Harbor StatementStatements
in this news release about Perspective Therapeutics, Inc.’s
(“Perspective”) future expectations, including: whether ongoing
favorable results of the compassionate use basis trials on the
patient will continue and whether those results can be
commercialized for wider use; whether the Phase I trial is
successful; expectations about the Company’s addressable markets;
the functionality and capabilities of the Company’s therapies
including its targeted alpha-particle radiotherapy; the potential
size of the commercial market for the Company’s treatment programs;
the Company’s expectations, beliefs, intentions, and strategies
regarding the future; and all other statements in this news
release, other than historical facts, are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 (“PSLRA”). This statement is included for the
express purpose of availing the Company of the protections of the
safe harbor provisions of the PSLRA. It is important to note that
actual results and ultimate corporate actions could differ
materially from those in such forward-looking statements based on
such factors as whether and to what extent the anticipated benefits
of the merger are realized; the ability to raise ongoing capital to
fund added costs of research and development related to the
Company’s business; the ability of the Company to manage growth and
successfully integrate its businesses; whether the Company can
maintain its key employees; whether additional studies are released
that reinforce the results of the studies discussed in this
presentation; whether the anticipated benefits of the Company’s
therapies are realized; training and use of the Company’s products;
market acceptance and recognition of the Company’s products; the
Company’s ability to enforce its intellectual property rights;
whether ongoing patient results are favorable and in line with the
conclusions of clinical studies and initial patient results;
successful completion of future research and development
activities; whether we, our distributors, and our customers will
successfully obtain and maintain all required regulatory approvals
and licenses to market, sell, and use our products in their various
forms; the procedures and regulatory requirements mandated by the
FDA for animal trials, human trials, clinical studies, Phase I and
II approvals and 510(k) approval and reimbursement codes; changes
in applicable laws and regulations; and other risks detailed from
time to time in the Company’s reports filed with the SEC.
Unless required to do so by law, we undertake no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise. For more information regarding risks and
uncertainties that could affect the Company’s results of operations
or financial condition, please review the definitive Proxy
Statement filed on November 7, 2022, and our Form 10-K filed on
September 28, 2022, with the SEC.
Legacy Isoray Investor Relations: Mark Levin (501) 255-1910
Legacy Viewpoint Molecular Targeting Investor Relations: Chuck Padala (917) 741-7792
Media and Public Relations: Sharon Schultz (302) 539-3747
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