Alpha Tau Announces Grant of Expanded Radioactive License and Final Pre-Clinical Laboratory Regulatory Approval at its Jerusalem Headquarters
March 03 2023 - 7:30AM
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 Israeli
Ministry of Environmental Protection has granted the Company an
amended radioactive license in the main manufacturing floor of its
production facility in Jerusalem, increasing the maximum allowable
amount of Thorium-228 for use and possession to produce Alpha DaRT
sources from 30 milliCurie to 100 milliCurie. This expanded license
could support the production of up to 300,000 Alpha DaRT sources
per year in this facility.
In addition, the Company is also pleased to announce that it has
received approvals from both the Israeli Ministry of Environmental
Protection and the Animal Testing Council at the Israeli Ministry
of Health for its pre-clinical radioactive laboratory at its
Jerusalem headquarters, to conduct pre-clinical experiments
utilizing mice and rats. The Company has now successfully completed
all requirements for the certification of this laboratory and may
begin submitting experimental protocols for ethics committee
approval.
Alpha Tau CEO Uzi Sofer commented, “As our clinical trials
continue to expand at an ever-increasing pace, led by our flagship
ReSTART multicenter cutaneous SCC pivotal study in the U.S.
alongside multiple trials in internal organs, the tremendous need
for ongoing expansion of our manufacturing capacity, both in the
U.S. and in Israel, remains critical to ensuring a steady supply of
our Alpha DaRT treatments. Likewise, we are continuously growing
our manufacturing and quality assurance teams to enable us to meet
our current and future goals for the foreseeable future. In
addition, with the exploration of combinations between the Alpha
DaRT and other cancer therapies remaining a cornerstore of our
strategy, our ability to test such combinations in-house in our own
pre-clinical lab will allow us to optimize such combinations
efficiently and help us examine a variety of possible combination
trials for exploration in people desperately suffering from
metastatic cancers.”
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 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; 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 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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