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 advanced inoperable pancreatic cancer has been treated in a
feasibility and safety study of Alpha DaRT at the Jewish General
Hospital (“JGH”) in Montreal, Canada, which is an affiliated
teaching hospital of McGill University, Faculty of Medicine.
The trial seeks to recruit 30 participants who have Stage II,
III, or IV pancreatic cancer and who have a pancreatic tumor which
is deemed inoperable due to non-resectability, metastasis, or lack
of fitness for surgery. The study will primarily examine 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 will
examine 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.
Alpha Tau CEO Uzi Sofer commented, “Getting this trial underway
is another huge milestone for the Company, as we continue to focus
on treating tumors in internal organs. We would like to thank Dr.
Corey Miller of the JGH for enrolling and treating the first
patient in this very important feasibility and safety trial.” Mr.
Sofer added, “This trial is a cornerstone of our overall strategy
to broaden the use of the Alpha DaRT in other hard-to-treat
indications such as cancers of the brain, lung, vulva and breast.
We look forward to the preliminary results of this trial, which we
hope will further our goal of advancing the use of Alpha DaRT
across a range of indications and helping patients worldwide.”
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, and the principal investigator of the trial,
commented, “The treatment of this first patient represents a major
milestone of an 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.” Dr. Miller continued, “Patients with stage II, III,
or IV of pancreatic cancer have limited and, often, ineffective
treatment options. With the Alpha DaRT technology and our expertise
in developing novel advanced endoscopic techniques, we are thrilled
to offer patients with inoperable advanced pancreatic cancer an
innovative therapeutic option. We hope that the Alpha DaRT
treatment will offer better outcomes to these patients with such a
challenging disease. We appreciate the unconditional support from
Alpha Tau and the MCTRC who worked together to eliminate any
barriers for opening this trial at our hospital and for securing a
straightforward procedure for Alpha DaRT insertion into the
pancreatic tumor.”
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
About the Jewish General Hospital
Since 1934, the Jewish General Hospital has served patients of
diverse religious, linguistic and cultural backgrounds who reside
in Montreal, elsewhere in Quebec, and beyond. As one of the
province's largest acute-care hospitals, this 553-bed McGill
University teaching hospital admits more than 22,000 patients per
year, while handling approximately 578,000 outpatient visits and
more than 3,600 births. The JGH is widely recognized for excellence
in various specialties, including oncology at the Segal Cancer
Centre, cardiology, neonatology, orthopedics, family medicine,
aging and emergency medicine. In addition, several
services—including the Emergency Department, Intensive Care,
Neonatal Intensive Care, Coronary Care and the operating
rooms—opened in a new critical-care pavilion in 2016. The hospital
has been designated by the government of Quebec as one of
Montreal's five major service centres; as a provincial centre for
high-risk obstetrical and neonatal care; and as a breast referral
and investigation centre. Treatment is provided by approximately
800 affiliated doctors, many of whom have teaching appointments at
McGill University, as well as more than 300 medical residents per
year, together with nursing and a wide range of allied health
services. The hospital's Lady Davis Institute is acknowledged as a
world leader in many fields of research, including cancer (the
Terry Fox Molecular Oncology Group), aging (the Bloomfield Centre
for Studies in Aging), epidemiology (the Centre for Clinical
Epidemiology and Community Studies), nursing (the Centre for
Nursing Research), cardiovascular disease, genetics, emergency
medicine, nephrology, and the psychosocial aspects of illness.
For media inquiries regarding Dr. Corey
Miller:
Pascal Fischer Research Communications Officer Lady Davis
Institute Tel.: 514 340-8222 x 28661 or 450
218-6487 pascal.fischer@ladydavis.ca
About the McGill Center for Translational Research in
Cancer (MCTRC)
The MCTRC is the translational research arm of the Segal Cancer
Centre and Lady Davis Research Institute at the Jewish General
Hospital. The MCTRC houses clinician scientists, and fundamental
researchers who conduct research in various areas of healthcare
interest. The focus is on innovation, new knowledge generation and
rapid translation of discoveries from the lab to the clinic. The
main objective of its members is to translate fundamental
laboratory and clinical research data into clinical outcomes of
benefit for the diagnosis, treatment and prevention of cancer. For
more information, please visit:
www.mcgill.ca/translational-research-cancer/
Contact: Miriam Santos Dutra, Chief Operating Officer. Email:
mctrc@ladydavis.ca
About MEDTEQ+
MEDTEQ+ is the pan-Canadian Consortium for Industrial Research
and Innovation in Medical Technology. Its mission is to accelerate
the development of innovative technological solutions to improve
patients’ health and quality of life. MEDTEQ+ supports their
validation and integration in the healthcare system and their
impact, both locally and globally, by bringing together the
complementary skills of industrial and academic partners, and with
those of healthcare providers. MEDTEQ+ receives financial support
of the Government of Quebec, the Government of Canada (delivered
through the Centres of Excellence for Commercialization and
Research (CECR)), the private sector and complementary partners to
foster research-industry relations. For more information, please
visit www.medteq.ca
Contact: Diane Cote, President and CEO MEDTEQ+
diane.cote@medteq.ca
About the TransMedTech Institute
The TransMedTech Institute (iTMT) aims to support innovation in
medical technologies to meet the needs of end-users and the
healthcare sector, in order to facilitate and accelerate their
development and implementation in the healthcare system. Under the
leadership of Polytechnique Montréal and four other founding
institutions (Université de Montréal, CHU Sainte-Justine, CHUM and
the Jewish General Hospital), the iTMT brings together more than
fifty partner institutions, together maintaining a first-rate
scientific infrastructure to support the development and validation
of medical technologies. The TransMedTech Institute is supported by
the Canada First Research Excellence Fund, the Ministère de
l'Économie, de l'Innovation et de l’Énergie du Québec and the Fonds
de recherche du Québec, as well as several other philanthropic,
government, socio-economic and industrial university partners.
Contact: Marie Pierre faure, Deputy Director, email :
marie-pierre.faure@polymtl.ca
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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/abad3f69-c53e-4bc5-b4e7-15b8feda6fe8
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