Perspective Therapeutics, Inc. (“Perspective” or “the
Company”) (NYSE AMERICAN: CATX), announced today that the first
patient was dosed at the University of Iowa in an
investigator-initiated Phase 1 trial evaluating the safety of
[212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in
patients with unresectable or metastatic somatostatin receptor type
2 (SSTR2) expressing neuroendocrine tumors (NETs). The patients
being enrolled in the study have either progressed or relapsed
after previous therapies, including currently approved peptide
receptor radionuclide therapies (“PRRT”).
The trial is a single-center, open-label study
of [212Pb]VMT-α-NET that is designed to explore safety and efficacy
when pre-treatment dose planning is aided by imaging with
[203Pb]VMT-α-NET using quantitative SPECT/CT imaging. Participants
are assigned a radiation dose to the kidneys that may not be
exceeded and is tailored to each person's unique tumor uptake of
[203Pb]VMT-α-NET and how long it lasts in the body.
“We are delighted that this innovative
investigator-initiated study has commenced in refractory and
relapsed neuroendocrine tumor patients,” said Thijs Spoor, Chief
Executive Officer at Perspective Therapeutics. “Along with our
company-sponsored first-line trial that is well underway, we expect
that the data gathered during this investigator initiated trial
from this previously treated population will increase the number of
patients who might be available to receive [212Pb]VMT-α-NET in the
future. The first-line PRRT setting has been commercially validated
by [177Lu]DOTATATE, and there has also recently been a great deal
of value ascribed to development in the PRRT-relapsed setting, so
we look forward to seeing the results of these investigations.”
“Although [177Lu]DOTATATE is effective at
delaying tumor progression in patients with NETs, we know that many
become refractory to treatment,” said Markus Puhlmann, Chief
Medical Officer of Perspective Therapeutics. “The preliminary data
from the clinical investigation program underway in India has shown
that responses are possible in PRRT-refractory and relapsed
settings, as presented at the European Association of Nuclear
Medicine meeting in September 2023. Although we believe
[212Pb]VMT-α-NET has the potential to provide significant
improvements in clinical outcomes compared to standard of care
[177Lu]DOTATATE, there is also a large number of patients who have
exhausted these treatment options. We are excited by this
collaboration, and we look forward to the Iowa team presenting
preliminary findings in 2024.”
About The StudyThis is a single
site safety study (clinicaltrials.gov identifier NCT06148636) of
[212Pb]VMT-α-NET targeted alpha-particle therapy for patients with
refractory or relapsed somatostatin receptor type 2
(SSTR2)-positive neuroendocrine tumors. The first part of this
Phase 1 trial is imaging with a surrogate tracer, [203Pb]VMT-α-NET,
using SPECT/CT imaging. Each participant is assigned a radiation
dose to the kidneys that cannot be exceeded.
The second part of the study is a sequential 3 +
3 dose escalation phase of 4 cohorts based on the maximum allowed
injected dose for an individual while keeping kidney exposure to
less than a predetermined threshold. The study involves 2
treatments, about 8 to 10 weeks apart. The drug will be given by
infusion once per treatment. Participants will also receive an
infusion of amino acids to help protect the kidneys as well as
medications to help protect against nausea. A participant
administered [212Pb]VMT-α-NET, will be monitored for at least 6
months for safety assessments. Participants will also have imaging
at 6 months post-treatment to measure how their tumors responded to
therapy and will have lifelong follow-up for this study.
About Neuroendocrine
TumorsNeuroendocrine tumors form in cells that interact
with the nervous system or in glands that produce hormones. They
can originate in various parts of the body, most often in the gut
or the lungs and can be benign or malignant. Neuroendocrine tumors
are typically classified as pancreatic neuroendocrine tumors or
non-pancreatic neuroendocrine tumors. According to cancer.net, it
is estimated that more than 12,000 people in the United States are
diagnosed with a NET each year. Importantly, neuroendocrine tumors
are associated with a relatively long duration of survival compared
to other tumors and as a result, there are approximately 175,000
people living with this diagnosis.
About VMT-α-NETVMT-α-NET is a
clinical stage targeted alpha particle therapy (TAT)
radiopharmaceutical 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. VMT-α-NET incorporates Perspective Therapeutics'
proprietary lead-specific chelator (PSC) to bind Pb-203 for SPECT
imaging, and Pb-212 for alpha particle therapy.
About Perspective Therapeutics,
Inc.Perspective Therapeutics, Inc., is a diversified
medical technology and radiopharmaceutical company that is
pioneering advanced treatment applications for cancers throughout
the body. The Company has a proprietary technology that utilizes
the alpha emitting isotope Lead-212 to deliver powerful 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 have entered 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 key isotopes for clinical trial and commercial
operations.
Perspective is the sole producer of Cesium-131
brachytherapy seeds which are commercially available in the United
States for the treatment of prostate cancer and other solid
tumors.
For more information, please visit the Company’s
website at www.perspectivetherapeutics.com .
Safe Harbor StatementThis press
release contains forward-looking statements within the meaning of
the United States Private Securities Litigation Reform Act of 1995.
Statements in this press release that are not statements of
historical fact are forward-looking statements. Words such as
"may," "will," "should," "expect," "plan," "anticipate," "could,"
"intend," "target," "project," "estimate," "believe," "predict,"
"potential" or "continue" or the negative of these terms or other
similar expressions are intended to identify forward-looking
statements, though not all forward-looking statements contain these
identifying words. Forward-looking statements in this press release
include statements concerning, among other things: the Company’s
expectation that the data gathered will increase the number of
patients who might be able to receive [212Pb]VMT-α-NET in the
future; the Company’s belief that [212Pb]VMT-α-NET has the
potential to provide significant improvements in clinical outcomes
compared to standard of care [177Lu]DOTATATE; the Company’s
expectation that the Iowa team will present preliminary findings in
2024; the Company’s prediction that complementary imaging
diagnostics that incorporate certain targeting peptides provide the
opportunity to personalize treatment and optimize patient outcomes;
the Company’s expectation that its "theranostic" approach enables
the ability to see specific tumors and then treat it to potentially
improve efficacy and minimize toxicity associated with many other
types of cancer treatments; the Company's clinical development
plans and the expected timing thereof; the potential functionality,
capabilities, and benefits of the Company's product candidates and
the potential application of these product candidates for other
disease indications; the Company's expectations, beliefs,
intentions, and strategies regarding the future; and other
statements that are not historical fact.
The Company may not actually achieve the plans,
intentions or expectations disclosed in the forward-looking
statements and you should not place undue reliance on the
forward-looking statements. These forward-looking statements
involve risks and uncertainties that could cause the Company's
actual results to differ materially from the results described in
or implied by the forward-looking statements, including, without
limitation: the potential that regulatory authorities may not grant
or may delay approval for the Company's product candidates;
uncertainties and delays relating to the design, enrollment,
completion, and results of clinical trials; unanticipated costs and
expenses; the Company’s ability to continue as a going concern;
early clinical trials may not be indicative of the results in later
clinical trials; clinical trial results may not support regulatory
approval or further development in a specified indication or at
all; actions or advice of regulatory authorities may affect the
design, initiation, timing, continuation and/or progress of
clinical trials or result in the need for additional clinical
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estimates regarding expenses, future revenue, capital requirements,
and the availability of and the need for additional financing; the
Company's ability to obtain additional funding to support its
clinical development programs; the availability or potential
availability of alternative products or treatments for conditions
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the Company's ability to maintain its key employees; whether there
is sufficient training and use of the Company's products and
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maintain and enforce its intellectual property rights; the
Company's ability to maintain its therapeutic isotope supply
agreement with the Department of Energy; the Company's ability to
continue to comply with the procedures and regulatory requirements
mandated by the FDA for additional trials, Phase 1 and 2 approvals,
FDA fast track approvals, and 510(k) approval and reimbursement
codes; and any changes in applicable laws and regulations. Other
factors that may cause the Company's actual results to differ
materially from those expressed or implied in the forward-looking
statements in this press release are described under the heading
"Risk Factors" in the Company's most recent Transition Report on
Form 10-KT and the Company's most recent Quarterly Report on Form
10-Q, each filed with the Securities and Exchange Commission (the
"SEC"), in the Company's other filings with the SEC, and in the
Company's future reports to be filed with the SEC and available at
www.sec.gov.
Forward-looking statements contained in this
press release are made as of this date, and the Company undertakes
no duty to update such information whether as a result of new
information, future events or otherwise, except as required under
applicable law.
Media and Investor Relations Contacts:
Russo Partners, LLC
Nic Johnson or Harrison Seidner, Ph.D.
E: Nic.johnson@russopartnersllc.com
E: Harrison.seidner@russopartnersllc.com
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