Full Press Release Details
Alpha Tau Announces Health Canada Authorization for Alpha DaRT Clinical
Trial for the Treatment of Liver Metastases
JERUSALEM, March 1, 2023 (GLOBE NEWSWIRE) -- 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 it has received authorization from Health Canada to proceed with a feasibility and safety study
of Alpha DaRT in the treatment of liver metastases, subject to final approval by an institutional Research Ethics Board, which the Company
expects to receive in the coming weeks. The study is planned to be conducted at the McGill University Health Center in Montreal, Canada.
The trial will seek to recruit
10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first
stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention while Alpha DaRT sources will be
inserted into a separate tumor, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of
the liver with the Alpha DaRT sources will be surgically removed.
The study primarily aims to examine
the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources
in the liver by assessing the frequency and severity of related adverse events. The study will also examine Alpha DaRT's efficacy
in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response assessed after the
second stage of surgery.
Alpha Tau CEO Uzi Sofer commented, "The authorization by Health
Canada for this study to proceed represents an important milestone for the Company. This trial examining the use of Alpha DaRT in liver
metastases for the first time signifies a big step forward in our overall strategy to broaden the use of the Alpha DaRT in hard-to-treat
indications, including other cancers such as those of the brain, lung, pancreas, vulva and breast."
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.
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