Alpha Tau Announces Multiple Corporate Updates Ahead of 2022 Annual Meeting of the American Society for Radiation Oncology
October 21 2022 - 4:01PM
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 its
participation in the upcoming 2022 Annual Meeting of the American
Society for Radiation Oncology (“ASTRO”), being held October 23 –
25, 2022 in San Antonio, TX, where the Company will be at Booth
#3719. Participants interested in meeting with the Alpha Tau team
at the conference can do so by booking a slot via the following
link: https://calendly.com/michaelt-alpha-dart/. Ahead of the
conference, the Company is pleased to announce a number of recent
developments:
- The Medicines
and Healthcare products Regulatory Agency (“MHRA”) of the United
Kingdom has approved the Company’s request to initiate a clinical
trial for the treatment of primary and recurrent Squamous Cell
Carcinoma of the vulva using the Alpha DaRT. The trial is expected
to be conducted with 10 patients, and will be led by Dr. Li Tee Tan
of Addenbrooke’s Hospital of the Cambridge University Hospitals NHS
Trust. The trial seeks to measure the feasibility, safety, efficacy
and immunological response associated with treatment with the Alpha
DaRT.
- Health Canada
has approved the Company’s request to revise its Investigational
Testing Authorization for the Company’s clinical trial testing the
feasibility and safety of the Alpha DaRT treatment in patients with
advanced pancreatic cancer. The revision allows the Company to add
Jewish General Hospital in Montreal, Canada as a second site to the
trial, alongside Centre Hospitalier de l’Université de Montréal
(CHUM).
- Dr. Christopher
Barker of Memorial Sloan Kettering Cancer Center in New York will
deliver a presentation at the ASTRO 2022 Annual Meeting, on
Wednesday, October 26, 2022 at 8:20am in the Henry B. Gonzalez
Convention Center, Room 303, entitled “A Multicenter Prospective
Trial of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or
Unresectable Cutaneous Cancers: Early Results from a Pilot
Feasibility Study in the United States,” providing further detail
on the results of the Company’s U.S. pilot feasibility study that
was conducted in 2021, the initial results of which were reported
earlier in 2022, including a 100% complete response rate observed
at 12 and 24 weeks after treatment with the Alpha DaRT.
- Following the
Company’s announcement in January 2022 that it had signed a
sponsored research agreement with investigators at The University
of Texas MD Anderson Cancer Center, the investigators presented a
poster at the Radiation Research Society’s 2022 Annual Meeting,
held October 16 – 19, 2022 in Waikoloa Village, Hawaii. The poster
detailed results of the investigators’ pre-clinical study using the
Alpha DaRT to treat mice with 4T1 triple-negative breast cancer
tumors, demonstrating significantly smaller tumor volume as well as
a significant two-fold increase in CD8+ cell populations in the
spleens of mice when treated with the Alpha DaRT vs. those treated
with inert sources. The investigators concluded that, “[Alpha] DaRT
seeds were effective in delaying tumor growth with activation of
the immune system…The magnitude of increase in CD8+ populations in
the irradiated spleens of mice suggests systemic activation of the
immune system.”
Alpha Tau CEO Uzi Sofer commented, “Following
the completion of our U.S. pilot study earlier this year, we are
laser-focused on initiating our U.S. multi-center pivotal study for
the treatment of recurrent cutaneous Squamous Cell Carcinoma using
the Alpha DaRT, which we expect to occur before the end of the
year, as we are currently progressing on the associated preparatory
logistics such as IRB approvals and site initiations. At the same
time, we continue to forge ahead in our strategy to broaden the
application of the Alpha DaRT to other indications, and are very
excited to see continued meaningful progress across three different
indications: cancer of the vulva, pancreas and breast. We look
forward to further advances in these and other indications, as we
continue to explore ways that the Alpha DaRT can help patients
around the world.”
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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