Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today
announced that it began patient recruitment for the second dosing
cohorts (Cohort 2) in clinical studies for both of its lead product
candidates, [212Pb]VMT-α-NET and [212Pb]VMT01, after the safety
monitoring committees for each study unanimously recommended moving
forward. In addition, the first patient in cohort 2 of the
[212Pb]VMT01 study was already dosed.
[212Pb]VMT-α-NET is a targeted alpha particle
therapy (TAT) in development for patients with unresectable or
metastatic somatostatin receptor type 2 (SSTR2) expressing tumors
who have not previously received peptide-targeted
radiopharmaceutical therapy, such as Lutathera. [212Pb]VMT01 is a
TAT in development for second-line or later treatment of patients
with progressive MC1R-positive metastatic melanoma.
“We continue to make rapid progress across all
of our clinical programs and demonstrate the promise of our
targeted alpha radioligand therapies to provide needed treatment
options for patients with intractable tumors,” commented Markus
Puhlmann, Chief Medical Officer of Perspective Therapeutics.
“Preliminary safety data from these Phase 1 studies of
[212Pb]VMT-α-NET and [212Pb]VMT01 demonstrate good tolerability and
support further dose escalation. The [212Pb]VMT-α-NET data are
consistent with the data collected at similar doses from the
clinician-initiated ongoing study in India. We look forward to
providing further safety and efficacy updates in the second half of
2024.”
About the Phase 1/2a Study of
[212Pb]VMT-α-NETThis is
a multi-center open-label study (clinicaltrials.gov identifier
NCT05636618) of [212Pb]VMT-α-NET, a targeted alpha particle
therapy, for patients with advanced SSTR2-positive neuroendocrine
tumors. The first part of the study involves dose-escalation
designed to determine the maximum tolerated dose (MTD) or maximum
feasible dose (MFD) following a single administration of
[212Pb]VMT-α-NET. The first patient cohort received 111 MBq (3mCi)
per dose. The second cohort will receive administered activities of
185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and
555 MBq (15 mCi), respectively, if the MTD or MFD is not reached
during escalation. According to the modified toxicity probability
interval 2 (mTPI-2) study design, intermediate de-escalation doses
are also possible to allow selection of the optimal activity dose
to take forward into the dose expansion part of the study.
The second part of the study is a dose expansion
phase based on the identified MTD/MFD. Patients with positive
uptake on FDA-approved SSTR2 PET/CT will receive a fixed dose of
[212Pb]VMT-α-NET IV administered at the recommended Phase 2 dose
and schedule determined in the Phase I dose escalation.
About the Phase 1/2a study of
[212Pb]VMT01This ongoing
trial (clinicaltrials.gov identifier NCT05655312) is a multi-center
open-label dose escalation, dose expansion study of [212Pb]VMT01 in
subjects with histologically confirmed melanoma and MC1R-positive
imaging scans. The first part of the study is a dose escalation
phase to determine the MTD or MFD following a single administration
of [212Pb]VMT01. The first patient cohort received 111 MBq (3mCi)
per dose. The second cohort will receive administered activities of
185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and
555 MBq (15 mCi) respectively, if the MTD or MFD is not reached
during escalation. According to the modified toxicity probability
interval 2 (mTPI-2) study design, intermediate de-escalation doses
are also possible to allow selection of the optimal activity dose
to take forward into the dose expansion part of the study.
The second part of the study is a dose expansion
phase based on the identified MTD/MFD. Patients may be eligible to
receive up to three administrations of [212Pb]VMT01 approximately
eight weeks apart. A dosimetry sub-study is included to assess
biodistribution, tumor uptake and correlation of uptake with
observed toxicities and efficacy.
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 MelanomaMelanoma is a
cancer of the skin arising from uncontrollable growth of
melanocytes, the melanin producing cells of the body. Metastatic
melanoma is the result of melanoma that has progressed through the
layers of skin, infiltrated the blood stream or lymphatic system,
and traveled to other areas of the body to metastasize. In the
United States, there are approximately 100,000 new diagnoses of
melanoma annually and approximately 6,850 deaths annually from
metastatic melanoma (cancer.org). In most cases, metastatic
melanoma cannot be cured but treatment can support a longer
life.
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 203Pb for SPECT
imaging, and 212Pb for alpha particle therapy.
About VMT01VMT01 is a
proprietary clinical-stage low molecular weight peptide that is
targeted to the melanocortin subtype 1 receptor (MC1R) which is
over-expressed on melanoma cells. VMT01 is in development for the
treatment and diagnosis of MC1R-positive metastatic melanoma. VMT01
can be labeled with 212Pb to deliver alpha-particle radiation
directly to tumor cells, or 203Pb to enable patient selection,
diagnostic imaging and dosimetry via SPECT imaging. The product
recently completed a pilot imaging study at the Mayo Clinic
Rochester, MN. In August 2023, the Company announced that the first
patient was dosed in the Phase1/2a study of VMT01
(clinicaltrials.gov identifier NCT05655312).
About Perspective Therapeutics,
Inc.Perspective Therapeutics, Inc. is a
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
212Pb 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
in the United States. The Company has also developed a proprietary
212Pb generator to secure key isotopes for clinical trial and
commercial operations.
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 successful
completion of patient recruitment for the second dosing cohorts in
clinical studies for both lead product candidates, [212Pb]VMT-α-NET
and [212Pb]VMT01; the potential of [212Pb]VMT-α-NET as a targeted
alpha particle therapy (TAT) in development for patients with
unresectable or metastatic somatostatin receptor type 2 (SSTR2)
expressing tumors who have not previously received peptide-targeted
radiopharmaceutical therapy; [212Pb]VMT01’s potential to be a
successful alpha-particle therapy in development for second-line or
later treatment of patients with progressive MC1R-positive
metastatic melanoma; the continued progress of all of the Company’s
clinical programs; the Company’s ability to continue to demonstrate
the promise of the Company’s targeted alpha radioligand therapies
to provide needed treatment options for patients with intractable
tumors; the ability for the safety data from the Phase 1 studies of
[212Pb]VMT-α-NET and [212Pb]VMT01 to continue to demonstrate good
tolerability and support further dose escalation; and the ability
for the Company to provide further safety and efficacy updates in
the second half of 2024.
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 Company's ability to continue as a going concern,
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; 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
trials; the Company's ability to obtain and maintain regulatory
approval for the Company's product candidates; delays,
interruptions or failures in the manufacture and supply of the
Company's product candidates; the size and growth potential of the
markets for the Company's product candidates, and the Company's
ability to service those markets; the Company's cash and cash
equivalents may not be sufficient to support its operating plan for
as long as anticipated; the Company's expectations, projections and
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
targeted by the Company that could affect the availability or
commercial potential of its product candidates; the ability of the
Company to manage growth and successfully integrate its businesses;
the Company's ability to maintain its key employees; whether there
is sufficient training and use of the Company's products and
product candidates; the market acceptance and recognition of the
Company's products and product candidates; the Company's ability to
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 news
release are made as of this date. 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.
Media and Investor Relations Contacts:
Russo Partners, LLC
Nic Johnson
nic.johnson@russopartnersllc.com
Adanna G. Alexander, Ph.D.
adanna.alexander@russopartnersllc.com
Harrison Seidner, Ph.D.
harrison.seidner@russopartnersllc.com
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