Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase
05 Setembro 2023 - 8:00AM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing targeted
radiotherapeutics with advanced platform technologies for central
nervous system cancers, today announced treatment of the first
patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose
escalation clinical trial of rhenium (186Re) obisbemeda for the
treatment of leptomeningeal metastases (LM) from solid tumors.
“The Phase 1/Part A data in the ReSPECT-LM
clinical trial is encouraging,” said Norman LaFrance M.D., Chief
Medical Officer of Plus Therapeutics. “In Phase 1/Part B, we plan
to dose escalate to the maximum tolerated single dose while
simultaneously collaborating with the U.S. Food and Drug
Administration (FDA) to implement multiple dosing into the
trial.”
The maximum total radiation activity
administered in Phase 1/Part A was 26.4 millicuries (mCi). In Phase
1/Part B the maximum administered total radiation activity will be
110.0 mCi in cohort 7.
Positive data from Part A (Cohorts 1-3) of the
ReSPECT-LM clinical study evaluating the Company’s lead
radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of
LM were presented at the Society for Neuro Oncology (SNO)/American
Society of Clinical Oncology (ASCO) Central Nervous System (CNS)
Cancer Conference in August 2023. In summary, the findings in the
Phase 1/Part A showed:
- Ten patients
were treated with a maximum absorbed dose of 85 Gray (Gy) and up to
26.4 mCi of radiation activity.
- No dose limiting
toxicities have been observed and a maximum tolerated dose or
maximum feasible dose has not been reached in Part A.
- Cerebrospinal
fluid (CSF) tumor cell counts, evaluated using a molecular
diagnostic assay, decreased an average of 53% measured at 28 days
post-treatment.
- In addition,
five of the 10 treated patients in Part A remain alive with a
median overall survival of 10 months.
The FDA has granted Fast Track designation to rhenium (186Re)
obisbemeda for the treatment of LM. The ReSPECT-LM clinical trial
is funded, in part, by a 3-year, $17.6 million grant by the Cancer
Prevention & Research Institute of Texas.
About Leptomeningeal Metastases
(LM)LM is a rare complication of cancer in which the
primary cancer spreads to the cerebrospinal fluid (CSF) and
leptomeninges surrounding the brain and spinal cord. All
malignancies originating from solid tumors, primary brain tumors,
or hematological malignancies have this LM complication potential
with breast cancer as the most common cancer linked to LM, with
3-5% of breast cancer patients developing LM. Additionally, lung
cancer, GI cancers and melanoma can also spread to the CSF and
result in LM. LM occurs in approximately 5% of people with cancer
and is usually terminal with 1-year and 2-year survival of just 7%
and 3%, respectively. The incidence of LM is on the rise, partly
because cancer patients are living longer and partly because many
standard chemotherapies cannot reach sufficient concentrations in
the spinal fluid to kill the tumor cells, yet there are no
FDA-approved therapies specifically for LM patients, who often
succumb to this complication within weeks to several months, if
untreated.
About Rhenium (186Re)
ObisbemedaRhenium (186Re) obisbemeda is a novel injectable
radiotherapy specifically formulated to directly deliver targeted
high-dose radiation in CNS tumors in a safe, effective, and
convenient administration. Rhenium (186Re) obisbemeda has the
potential to reduce risks and improve outcomes for CNS cancer
patients, versus currently approved therapies, with a more targeted
and potent radiation dose. Rhenium-186 is an ideal radioisotope for
CNS therapeutic applications due to its short half-life, beta
energy for destroying cancerous tissue, and gamma energy for
real-time imaging. Rhenium (186Re) obisbemeda is being evaluated
for the treatment of recurrent glioblastoma and leptomeningeal
metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials.
ReSPECT-GBM is supported by an award from the National Cancer
Institute (NCI), part of the U.S. National Institutes of Health
(NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the
Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a robust supply chain through strategic
partnerships that enable the development, manufacturing, and future
potential commercialization of its products. Plus Therapeutics is
led by an experienced and dedicated leadership team and has
operations in key cancer clinical development hubs including Austin
and San Antonio, Texas. For more information, visit
https://plustherapeutics.com/.
Cautionary Statement Regarding
Forward-Looking StatementsThis press release contains
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws. All statements in this press
release other than statements of historical fact are
forward-looking statements. These forward-looking statements may be
identified by future verbs, as well as terms such as “designed to,”
“will,” “can,” “potential,” “focus,” “preparing,” “next steps,”
“possibly,” and similar expressions or the negatives thereof. Such
statements are based upon certain assumptions and assessments made
by management in light of their experience and their perception of
historical trends, current conditions, expected future developments
and other factors they believe to be appropriate. These statements
include, without limitation, statements regarding the following:
the potential promise of 186Re including the ability of 186Re to
safely and effectively deliver radiation directly to the tumor at
high doses; expectations as to the Company’s future performance
including the next steps in developing the Company’s current
assets; the Company’s clinical trials including statements
regarding the timing and characteristics of the ReSPECT-GBM and
ReSPECT-LM clinical trials; possible negative effects of 186Re; the
continued evaluation of 186Re including through evaluations in
additional patient cohorts; and the intended functions of the
Company’s platform and expected benefits from such functions.
The forward-looking statements included in this
press release are subject to a number of risks and uncertainties
that may cause actual results to differ materially from those
discussed in such forward-looking statements. These risks and
uncertainties include, but are not limited to: the Company’s actual
results may differ, including materially, from those anticipated in
these forward-looking statements as a result of various factors,
including, but not limited to, the following: the early stage of
the Company’s product candidates and therapies, the results of the
Company’s research and development activities, including
uncertainties relating to the clinical trials of its product
candidates and therapies; the Company’s liquidity and capital
resources and its ability to raise additional cash, the outcome of
the Company’s partnering/licensing efforts, risks associated with
laws or regulatory requirements applicable to it, market
conditions, product performance, litigation or potential
litigation, and competition within the cancer diagnostics and
therapeutics field, among others; and additional risks described
under the heading “Risk Factors” in the Company’s Securities and
Exchange Commission filings, including in the Company’s annual and
quarterly reports. There may be events in the future that the
Company is unable to predict, or over which it has no control, and
its business, financial condition, results of operations and
prospects may change in the future. The Company assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends, or circumstances after the date they are
made unless the Company has an obligation under U.S. federal
securities laws to do so.
Investor ContactPeter VozzoICR Westwicke(443)
377-4767Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerICR Westwicke(203)
856-4326Terri.Clevenger@westwicke.com
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