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 the release of interim
results from treatment of the first five patients in the Company’s
safety and feasibility trial examining the use of Alpha DaRT to
treat advanced pancreatic cancer, currently underway at two
university hospitals in Montreal, Canada.
The first five patients were treated at the Jewish General
Hospital, an affiliated teaching hospital of McGill University,
Faculty of Medicine in Montreal, Canada, in accordance with the
study protocol calling for a pace of approximately one patient per
month, pending results from the interim safety read-out from the
first five patients. Levels of radium-224 activity were increased
from one patient to the next. Tumor stages of the treated patients
ranged from stage II to stage IV, and treated tumors were located
in the pancreatic head or neck. Four of the five patients had been
previously treated with chemotherapy before enrolling in the
study.
With respect to primary outcome measures, the Alpha DaRT
procedure was deemed technically successful in all five cases, with
Alpha DaRT sources successfully inserted into the target tumor. In
addition, there were no reported serious adverse events deemed
related to the product. The only reported adverse events deemed
possibly related to the product were of severity grade 1
(mild).
The first two patients, who had received the fewest number of
Alpha DaRT sources, both died approximately three months after
treatment, and the deaths were not related to Alpha DaRT treatment.
The other three patients, who are still undergoing regular
follow-up multiple months after treatment, all demonstrated stable
disease responses at four weeks after treatment, i.e., neither
material shrinkage nor material increase in the longest dimension
of the treated tumor. The third patient treated, for whom the
coverage of gross tumor volume at 16 Gy alpha radiation dose was
estimated at 44% after treatment, was upgraded to partial response
upon evaluation at 69 days after treatment, i.e., the treated tumor
shrank by at least 30% on its longest dimension vs. the baseline
measurement.
Alpha Tau CEO Uzi Sofer commented, “These initial results have
surpassed our expectations, with complete success in delivery,
minimal product-related side effects observed thus far, and our
first patient with an overall response to the treatment, despite
our conservative gradual step up of tumor coverage from minimal
initial levels. This trial is a cornerstone of our overall strategy
to broaden the use of the Alpha DaRT in hard-to-treat indications,
and the promising results to date are very timely given that
November is Pancreatic Cancer Awareness month. We look forward to
completing this trial as well as generating important data in other
cancers such as those of the brain, lung, vulva and breast, and
future expansion into examination of Alpha DaRT in combination with
systemic therapies in settings such as the pancreas.”
Corey Miller, MD, CM, FRCPC, Director of Therapeutic Endoscopy
of the Division of Gastroenterology of the JGH, Assistant Professor
of Medicine at McGill University, Associate Researcher at the Lady
Davis Institute, Associate Member of the McGill Centre for
Translational Research in Cancer and principal investigator of the
trial, noted, “We were excited to offer this treatment to some of
our most advanced patients, as part of the on-going partnership
between the departments of Gastroenterology and Radiation Oncology
of the JGH, the McGill Centre for Translational Research in Cancer
(MCTRC) of the Lady Davis Institute, MEDTEQ+ (the pan-Canadian
consortium for research and innovation in medical technologies) and
the Institute TransMedTech. We have been positively surprised by
the ease of use and accuracy in delivering Alpha DaRT sources into
the pancreas, with each procedure taking under an hour, and we
continue to learn more about the delivery with each procedure. We
are encouraged by the initial outcomes in this trial to date, and
needless to say, these fantastic initial results only increase our
interest to broaden our use of Alpha DaRT in patients with this
deadly disease.”
Alpha Tau Chief Medical Officer Dr. Robert Den added, “We are
extremely pleased with our first release of clinical trial data
from use of Alpha DaRT in treating internal organs. This procedure
was enabled by a special-purpose applicator we designed for
integration with existing equipment in the hospital, with limited
need for additional specialized equipment and an intuitive method
of delivery for the clinicians. Having observed strong initial
results in the first five patients, we look forward to this trial
progressing swiftly without the restriction of one patient per
month, to allow us to generate a more complete dataset in 2024. In
such a difficult setting, we would expect that any radiotherapy
product demonstrating meaningful efficacy in treating pancreatic
adenocarcinoma would be welcome news for patients and clinicians
alike.”
The trial seeks to recruit 37 participants who have Stage II to
IV pancreatic adenocarcinoma which is deemed inoperable due to
non-resectability, metastasis, or lack of fitness for surgery. The
study primarily examines the safety and feasibility of placing the
Alpha DaRT sources in the tumor utilizing endoscopic ultrasound,
and the overall safety of the procedure by measuring adverse
events. In addition, the study examines the efficacy of Alpha DaRT
in terms of metrics such as overall response rate, overall survival
and change in blood levels of CA19-9 (a blood-based biomarker often
correlated with metrics such as disease progression). Additional
information about the trial can be found at
https://www.clinicaltrials.gov/ct2/show/NCT04002479.
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.
Investor Relations Contact
IR@alphatau.com
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.
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