JERUSALEM, Oct. 25, 2021 /PRNewswire/ -- Alpha Tau Medical
Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation
cancer therapy Alpha DaRT, announced today that its US pilot trial
for skin cancer has completed enrollment as planned. This
announcement comes less than four months after the first patient
was recruited into the trial in July
2021. Alpha DaRT sources were successfully implanted into
all patients and then removed two to three weeks later as
scheduled, and no serious adverse events related to the Alpha DaRT
were noted at the time of removal. As such, the trial has met its
first primary objective, in demonstrating feasibility of successful
delivery of the Alpha DaRT. With respect to its co-primary
objective of assessing the frequency and severity of acute adverse
events related to the Alpha DaRT, treatment-related adverse events
seen thus far have been in line with those seen in previous human
trials of the Alpha DaRT and will be monitored throughout the
remainder of the follow-up period. Tumor response, a secondary
objective of the trial, will be assessed in each patient three
months after Alpha DaRT removal.
The pilot study is designed to evaluate the feasibility of Alpha
DaRT in treating ten subjects with malignant skin and superficial
soft tissue tumors. The primary objectives are to explore the
feasibility of delivering radiotherapy for malignant skin and
superficial soft tissue tumors using Alpha DaRT, with a goal of
achieving successful delivery in at least seven of the ten
patients, as well as to determine the frequency and severity of
acute adverse events. Secondary objectives include assessments of
radiotherapy-related adverse events, tumor response, radiation
safety, stability of device placement, and quality of life
measures. The trial is being conducted in multiple sites across the
U.S.
Alpha Tau CEO Uzi Sofer remarked,
"We are thrilled about having reached this major milestone for the
company, with the completion of recruitment for our first U.S.
trial, and are appreciative of all of our trial site investigators,
whose excitement for the tremendous potential of the Alpha DaRT
helped us recruit patients swiftly. With our Breakthrough Device
Designation for the treatment of certain patients with squamous
cell carcinoma assisting our navigation of potential FDA regulatory
pathways, we look forward to potentially moving into a U.S. pivotal
trial in 2022, with the goal of bringing the Alpha DaRT closer to
availability for patients around the country as quickly as
possible."
"The novelty of the Alpha DaRT has sparked great excitement in
the U.S. oncology community as evidenced by our brisk accrual,"
said Alpha Tau CMO, Dr. Robert
Den. "We look forward to our forthcoming pivotal trial
as we strive to bring this revolutionary technology to the
market."
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 source 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.
On July 8, 2021, Alpha Tau
announced that it had entered into a definitive merger agreement
(the "Merger Agreement") with Healthcare Capital Corp. (Nasdaq:
HCCC) ("HCCC"), a special purpose acquisition company, pursuant to
which Alpha Tau would consummate a business combination transaction
(the "Business Combination") with HCCC and become a Nasdaq-listed
public company.
Media Package: https://www.alphatau.com/media-package
Additional Information and Where to Find It
For additional information on the Business Combination, see
HCCC's Current Report on Form 8-K, which was filed with the
Securities and Exchange Commission ("SEC") on July 8, 2021.
In connection with the proposed transaction with HCCC, Alpha Tau
has filed a Registration Statement on Form F-4, which includes a
preliminary proxy statement/prospectus of HCCC.
Investors and security holders of HCCC are advised to read, when
available, the preliminary proxy statement, and amendments thereto,
and the definitive proxy statement in connection with HCCC's
solicitation of proxies for its special meeting of stockholders to
be held to approve the proposed Business Combination because the
proxy statement/prospectus will contain important information about
the proposed transaction and the parties to the proposed
transaction. The definitive proxy statement/prospectus will be
mailed to stockholders of HCCC as of a record date to be
established for voting on the proposed Business Combination.
Stockholders will also be able to obtain copies of the
Registration Statement, proxy statement/prospectus, and Form 8-K,
without charge at the SEC's website at www.sec.gov.
No Offer or Solicitation
This announcement is for informational purposes only and is
neither an offer to purchase, nor a solicitation of an offer to
sell, subscribe for or buy any securities or the solicitation of
any vote in any jurisdiction pursuant to the proposed Business
Combination or otherwise, nor shall there be any sale, issuance or
transfer or securities in any jurisdiction in contravention of
applicable law. No offer of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
HCCC and Alpha Tau and their respective directors, executive
officers, other members of management, and employees, under SEC
rules, may be deemed to be participants in the solicitation of
proxies of HCCC's stockholders in connection with the proposed
Business Combination between HCCC and Alpha Tau. Investors and
security holders may obtain more detailed information regarding the
names and interests in the proposed transaction of HCCC's directors
and officers HCCC's and Alpha Tau's filings with the SEC, including
the Registration Statement.
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 and HCCC'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 occurrence of
any event, change or other circumstances that could give rise to
the termination of the Merger Agreement and the proposed Merger
contemplated thereby; (xiv) the inability to complete the
transactions contemplated by the Merger Agreement due to the
failure to obtain approval of the stockholders of HCCC or other
conditions to closing in the Merger Agreement; (xv) the inability
to meet the aggregate transaction proceeds requirements of the
Merger Agreement due to the inability to consummate the PIPE
Investment or the amount of cash available following any
redemptions by HCCC's stockholders; (xvi) the ability to meet
Nasdaq's listing standards following the consummation of the
transactions contemplated by the Merger Agreement; (xvii) the risk
that the proposed transactions disrupt current plans and operations
of Alpha Tau as a result of the announcement and consummation of
the transaction described herein; (xviii) the ability to recognize
the anticipated benefits of the proposed Merger, which may be
affected by, among other things, competition, the ability of the
combined company to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain its
management and key employees; (xix) costs related to the proposed
Merger; (xx) changes in applicable laws or regulations; (xxi)
impacts from the COVID-19 pandemic; and the other important factors
discussed under the caption "Risk Factors" in Alpha Tau's
Registration Statement on Form F-4 originally filed with the SEC on
August 19, 2021 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 our 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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Contact:
Amnon Gat
+972-54-9746276
amnong@alphatau.com
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SOURCE Alpha Tau Medical