Alpha Tau Announces FDA Approval of IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC
20 Settembre 2024 - 2:30PM
Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ:
DRTS, DRTSW), the developer of the innovative alpha-radiation
cancer therapy Alpha DaRT®, announced today that the U.S. Food and
Drug Administration (FDA) has approved an Investigational Device
Exemption (IDE) application to initiate a multi-center study for
the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC)
in immunocompromised patients using the Alpha DaRT.
The clinical study, which is an investigator-initiated study led
by the Winship Cancer Institute of Emory University in Atlanta, has
been approved to enroll up to 28 U.S. patients at up to 8
institutions in the U.S., and will focus on patients with recurrent
cSCC who have a weakened immune system due to any primary or
secondary immunodeficiencies, excluding diabetes. The primary
efficacy objective of the study is the objective response rate
(ORR) to the treatment, as measured by best overall response.
Secondary efficacy objectives include progression-free survival,
overall survival and local control up to twelve months after
treatment, and the safety objective is the measurement of any
related adverse events.
A 2015 article in Journal of Clinical Medicine noted that
non-melanoma skin cancers represent a major cause of morbidity for
patients after organ transplantation, and cSCC is the most common
skin cancer seen in this population, with a 65–100 fold greater
incidence in organ transplant recipients compared to the general
population. For example, a 2003 article in the New England Journal
of Medicine cited a number of sources indicating that 50% or more
of Caucasian transplant recipients will ultimately develop
cutaneous carcinomas.
In addition, a 2019 article in JAMA Otolaryngology – Head &
Neck Surgery found that immunosuppression is independently
associated with a worse outcome in cSCC, with a 2.32-times
increased risk of disease-specific death, after adjusting for
assorted demographic factors.
"As we continue to progress in our ReSTART multi-center pivotal
trial for recurrent cutaneous SCC, a number of investigators asked
about the ability to treat immunocompromised patients, who are
ineligible for the ReSTART trial," commented Alpha Tau CEO Uzi
Sofer. "Emory University is an important partner of ours and we are
proud to work with them in initiating a trial for this population.
Given the continued requests we receive from clinicians to help
them treat immunocompromised patients, we are confident that a
successful clinical trial can help deliver an important new
potential alternative for these patients."
Zachary Buchwald, MD, PhD, an Assistant Professor of Radiation
Oncology at Winship Cancer Institute of Emory University and
Principal Investigator of the trial, noted, “We are thrilled to be
able to initiate this trial and pioneer the use of the Alpha DaRT
in immunocompromised patients. As we continue to see the promise of
the Alpha DaRT through our participation in the ReSTART trial, it
is obvious to us that we need to use this treatment elsewhere,
particularly in populations at risk such as this.”
Dr. Robert B. Den, Alpha Tau Chief Medical Officer, added, "This
trial targets a particularly vulnerable population for whom
treatment options are limited, which affords the ability to provide
even more potential value to these patients. We are looking forward
to treating patients in this trial soon."
About Alpha DaRT®
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is
designed to enable highly potent and conformal alpha-irradiation of
solid tumors by intratumoral delivery of radium-224 impregnated
sources. When the radium decays, its short-lived daughters are
released from the sources and disperse while emitting high-energy
alpha particles with the goal of destroying the tumor. Since the
alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims
to mainly affect the tumor, and to spare the healthy tissue around
it.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics
company that focuses on research, development, and potential
commercialization of the Alpha DaRT for the treatment of solid
tumors. The technology was initially developed by Prof. Itzhak
Kelson and Prof. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. When used herein, words including "anticipate," "being,"
"will," "plan," "may," "continue," and similar expressions are
intended to identify forward-looking statements. In addition, any
statements or information that refer to expectations, beliefs,
plans, projections, objectives, performance or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking. All forward-looking
statements are based upon Alpha Tau's current expectations and
various assumptions. Alpha Tau believes there is a reasonable basis
for its expectations and beliefs, but they are inherently
uncertain. Alpha Tau may not realize its expectations, and its
beliefs may not prove correct. Actual results could differ
materially from those described or implied by such forward-looking
statements as a result of various important factors, including,
without limitation: (i) Alpha Tau's ability to receive regulatory
approval for its Alpha DaRT technology or any future products or
product candidates; (ii) Alpha Tau's limited operating history;
(iii) Alpha Tau's incurrence of significant losses to date; (iv)
Alpha Tau's need for additional funding and ability to raise
capital when needed; (v) Alpha Tau's limited experience in medical
device discovery and development; (vi) Alpha Tau's dependence on
the success and commercialization of the Alpha DaRT technology;
(vii) the failure of preliminary data from Alpha Tau's clinical
studies to predict final study results; (viii) failure of Alpha
Tau's early clinical studies or preclinical studies to predict
future clinical studies; (ix) Alpha Tau's ability to enroll
patients in its clinical trials; (x) undesirable side effects
caused by Alpha Tau's Alpha DaRT technology or any future products
or product candidates; (xi) Alpha Tau's exposure to patent
infringement lawsuits; (xii) Alpha Tau's ability to comply with the
extensive regulations applicable to it; (xiii) the ability to meet
Nasdaq's listing standards; (xiv) costs related to being a public
company; (xv) changes in applicable laws or regulations; and the
other important factors discussed under the caption "Risk Factors"
in Alpha Tau's annual report filed on form 20-F with the SEC on
March 7, 2024, and other filings that Alpha Tau may make with the
United States Securities and Exchange Commission. These and other
important factors could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
Alpha Tau may elect to update such forward-looking statements at
some point in the future, except as required by law, it disclaims
any obligation to do so, even if subsequent events cause its views
to change. These forward-looking statements should not be relied
upon as representing Alpha Tau's views as of any date subsequent to
the date of this press release.
Investor Relations Contact:
IR@alphatau.com
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