Alpha Tau Expands its Alpha DaRT Treatment to Vulvar Cancer in Novel Clinical Trial with Cambridge University
May 17 2023 - 4:30PM
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 its first patient
with squamous cell carcinoma of the vulva has been treated in a
feasibility and safety study of Alpha DaRT at Addenbrookes Hospital
of the Cambridge University Hospitals NHS Foundation Trust in
Cambridge, England.
The investigator-initiated trial seeks to recruit 10
participants who have newly diagnosed or locally recurrent vulva
cancer with or without distant metastases. The study will
assess the safety and feasibility of using the Alpha DaRT by
measuring the treatment-related adverse events in the 6-month
follow-up period. In addition, the study will also examine the
efficacy of Alpha DaRT in terms of tumor response at 4 weeks after
Alpha DaRT insertion using RECIST criteria, histological evidence
of necrosis in pathological lymph nodes (if removed) and percentage
of necrotic tissue (if residual tumor is removed surgically) at 4-6
weeks, local control rate at 3-month and 6-month follow up visits,
patient-rated pain score, mental state and physical state over the
6-month follow up period. Additional information about the trial
can be found at
https://clinicaltrials.gov/ct2/show/NCT04761146.
Alpha Tau CEO Uzi Sofer commented, “The initiation of this trial
is a perfect example of how Alpha Tau is forging ahead in our
strategy to address clinical indications of high unmet medical
need. We would like to thank Dr. Li Tee Tan at Addenbrookes
Hospital of the Cambridge University Hospitals NHS Foundation Trust
for enrolling and treating the first patient in this pioneering
feasibility and safety trial.” Mr. Sofer added, “This trial is an
important building block in the foundation of our overall strategy
to broaden the use of the Alpha DaRT in other hard-to-treat
indications such as cancers of the brain, pancreas, lung, and
breast. We look forward to the preliminary results of this trial,
which we hope will further our goals of advancing the use of Alpha
DaRT across a range of indications and helping patients
worldwide.”
Li Tee Tan, MBBS, FRCR, MRCP, MD, Consultant Clinical Oncologist
at Addenbrooke’s Hospital, Cambridge University Hospitals NHS
Foundation Trust and the principal investigator of the trial,
commented, “The treatment of this first patient represents a major
new advance in the treatment of this disease. Patients with this
disease are usually faced with major and potentially deformative
surgery as standard treatment. However, depending on the extent and
location of disease, the short and long-term complications of
surgery are often significant and can be life changing. We are
hopeful that treatment with the novel and promising Alpha DaRT may
offer better outcomes to these patients with such a challenging
disease. We appreciate the support from Alpha Tau Medical Ltd. and
the CCTU-Cancer Theme for opening this trial and for securing a
straightforward procedure for Alpha DaRT insertion into the
cancerous lesion.”
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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