Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurrent Head and Neck Cancer
20 Novembre 2023 - 2:30PM
Alpha Tau Medical Ltd. ("Alpha Tau") (NASDAQ: DRTS, DRTSW), the
developer of the innovative alpha-radiation cancer therapy Alpha
DaRT™, and HekaBio K.K. (“HekaBio”) a Japan-based healthcare
investment, development and commercialization platform which is
partnered with Alpha Tau, announced today that Japan’s
Pharmaceuticals and Medical Devices Agency (“PMDA”) has accepted
Alpha Tau’s submission requesting shonin pre-market approval of
Alpha DaRT in patients with recurrent head & neck cancer,
following multiple pre-submission consultation meetings with the
PMDA per common practice in Japan. This submission is based upon
Alpha DaRT’s clinical trial results in Japan which exceeded the
target endpoints for safety and efficacy in patients with recurrent
head and neck cancer.
The head and neck cancer indication includes all solid tumor
cancer types after prior radiation treatment, including squamous
cell carcinoma, basal cell carcinoma, and melanoma. According to
the most recent registry of the Japan Society of Head & Neck
Cancer, there are more than 10,000 new cases of head and neck
cancers in Japan each year. Alpha Tau and HekaBio are in advanced
discussions with a number of large biopharmaceutical companies
regarding a potential long-term commercial partnership in Japan for
this and future indications.
Uzi Sofer, CEO of Alpha Tau, noted, “We identified Japan as an
important strategic market and initiated a local clinical trial
early on in our clinical development, and we are excited that this
trial has not only met but exceeded its endpoints. We are working
on all necessary preparations ahead of potential approval and
commercialization, while continually considering other indications
for initiating clinical trial investigation in Japan based on the
specific patient needs there.”
Rob Claar, CEO of HekaBio, added, “I am pleased that following
the successful completion of the clinical trial and collaborative
consultations to date, the PMDA has accepted our submission. In
light of the relatively high mortality rate and significant
morbidities associated with existing treatments in head & neck
cancer, we are excited about the potential to bring a new
alternative to the Japanese market. We continue to work with Alpha
Tau to find the best commercial partner for the Japanese market, in
order to be prepared for launch as quickly as possible.”
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau Medical 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.
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 HekaBio K.K.
HekaBio is a Japan-based healthcare investment, development and
commercialization platform advancing a synergistic portfolio of
breakthrough diagnostic and therapeutic solutions in cardiology,
neurology, oncology and ophthalmology. HekaBio offers global
healthcare technology innovators value-enhancing access to Japan,
the world's third largest market and strategic gateway to the rest
of Asia.
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 9, 2023, 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 and Media Contact:
Alpha Tau Medical Ltd.IR@alphatau.com
HekaBio K.K.Mari Tanaka, Corporate
Communicationsinfo@heka.bio
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