JERUSALEM, June 22,
2022 /PRNewswire/ -- Alpha Tau Medical Ltd. (Nasdaq:
DRTS) ("Alpha Tau"), the developer of the innovative
alpha-radiation cancer therapy Alpha DaRT™, announced today that
the first patient was treated in a feasibility study evaluating the
Alpha DaRT as a neoadjuvant therapy in patients with prostate
cancer at the Rambam Health Care Center in Haifa, Israel.
The primary objectives of this study are to assess the
feasibility and safety of intratumoral Alpha DaRT source
implantation for the treatment of local prostate cancer prior to
surgery. Secondary objectives include assessing radiological and
pathological objective response rate of the tumor, and changes in
quality of life measures. The study involves two separate
procedures, with surgical resection of the prostate 50 days
following Alpha DaRT source insertion, and can recruit up to 10
patients. The surgical resection will be performed at the Carmel
Medical Center in Haifa, Israel
using a da Vinci® surgical robot, and will be led by Dr.
Yuval Freifeld and his senior
team.
"This is a historic day for Alpha Tau," said Alpha Tau CEO
Uzi Sofer. "After gaining a wealth
of experience in treating superficial cancers such as those of the
skin, head & neck, and breast, we are thrilled to have treated
the first prostate patient, our first internal organ treatment. Our
pre-clinical data show that the Alpha DaRT technology may have
potential to address a very broad range of solid tumor types, and
our strategy is to expand our clinical studies across multiple
tumor types in order to evaluate the full potential of the Alpha
DaRT. This study suggests our ability to deliver this promising
treatment beyond superficial tumors and is an important milestone
in executing on this strategy."
Alpha Tau CMO Dr. Robert Den
remarked, "Since the prostate is surgically removed 50 days after
the Alpha DaRT insertion, the neoadjuvant design of this trial will
allow us to analyze the pathological response of tissues to the
Alpha DaRT. This will hopefully provide very valuable information
to our researchers and allow us to compare theoretical versus
actual cell damage."
Dr. Tomer Charas, head of the GU Radiotherapy Unit in the
Oncology Division at Rambam Health Care Center in Haifa, Israel, and principal investigator of
the study, commented, "We are excited to be leading this trial in
collaboration with the Carmel Urology team, and to be the first to
evaluate Alpha DaRT in prostate cancer in patients. Based on the
results from preclinical studies, it is possible that neoadjuvant
treatment with the Alpha DaRT may also trigger an immune response,
which could help decrease the risk of tumor recurrence. In
addition, a preferable safety profile has been observed to date in
treatments of other tumor types."
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;
(xix) impacts from the COVID-19 pandemic; 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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SOURCE Alpha Tau Medical