JERUSALEM, June 8, 2022
/PRNewswire/ -- Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW),
("Alpha Tau" or the "Company"), the developer of the innovative
alpha-radiation cancer therapy Alpha DaRT™, announced today that
the U.S. Food and Drug Administration (FDA) has conditionally
approved the Company's Investigational Device Exemption (IDE)
application to initiate its multi-center pivotal study for the
treatment of recurrent cutaneous Squamous Cell Carcinoma (SCC)
using the Alpha DaRT.
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The clinical study, entitled "A Prospective Multicenter,
Pivotal, Single Arm, Open Label Clinical Study to Assess the
Efficacy and Safety of Intratumoral Alpha DaRT for the Treatment of
Patients with Recurrent Cutaneous Squamous Cell Carcinoma" has been
approved to enroll up to 86 U.S. patients at up to 20 institutions
in the U.S., in addition to any sites that may be added outside the
U.S., and will focus on patients with recurrent cutaneous SCC who
have failed at least first line standard of care therapy and are
not indicated for another curative standard of care therapy.
"We are very excited about the upcoming commencement of our U.S.
pivotal study, undoubtedly our most significant clinical trial to
date," commented Alpha Tau CEO Uzi Sofer. "Our receipt of FDA
conditional approval of our IDE submission is a critical milestone
on our journey to bringing this exciting new therapy to patients in
the U.S. and around the world"
Dr. Robert B. Den, Alpha Tau
Chief Medical Officer, added, "We are thrilled to have received FDA
conditional approval of our IDE, after tremendous focus on the U.S.
over the past year, including successful completion of our pilot
study and the upcoming initiation of this pivotal study under the
FDA's Breakthrough Device Designation Program. We have seen
tremendous engagement and excitement from dozens of leading
institutions in the U.S. and around the world, keen to be part of
this study, and look forward to working with them on this clinical
study."
Yaniv Sagie, Alpha Tau VP Quality
and Regulatory Affairs, noted, "This amazing milestone represents
the culmination of Alpha Tau's rigorous teamwork and unwavering
commitment to quality and regulatory excellence."
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 insertion of radium-224 impregnated seeds. When the
radium decays, its short-lived daughters are released from the
seed, 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 medical device 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;
(xix) impacts from the COVID-19 pandemic; and the other important
factors discussed under the caption "Risk Factors" in Alpha Tau's
Annual Report on Form 20-F filed with the SEC on March 28,
2022, 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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SOURCE Alpha Tau Medical