Full Press Release Details
Tau Announces FDA Approval of IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT in Immunocompromised
Patients with Recurrent cSCC
to focus on particularly vulnerable subset of patients, following strong clinician interest in use of the Alpha DaRT in this patient
September 20, 2024 -- 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 the U.S. Food and Drug Administration
(FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent
cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT.
clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been
approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have
a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the
study is the objective response rate (ORR) to the treatment, as measured by best overall response. Secondary efficacy objectives include
progression-free survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement
of any related adverse events.
2015 article in Journal of Clinical Medicine noted that non-melanoma skin cancers represent a major cause of morbidity for patients
after organ transplantation, and cSCC is the most common skin cancer seen in this population, with a 65-100 fold greater incidence
in organ transplant recipients compared to the general population. For example, a 2003 article in the New England Journal of Medicine
cited a number of sources indicating that 50% or more of Caucasian transplant recipients will ultimately develop cutaneous carcinomas.
addition, a 2019 article in JAMA Otolaryngology - Head & Neck Surgery found that immunosuppression is independently
associated with a worse outcome in cSCC, with a 2.32-times increased risk of disease-specific death, after adjusting for assorted demographic
we continue to progress in our ReSTART multi-center pivotal trial for recurrent cutaneous SCC, a number of investigators asked about
the ability to treat immunocompromised patients, who are ineligible for the ReSTART trial," commented Alpha Tau CEO Uzi Sofer. "Emory
University is an important partner of ours and we are proud to work with them in initiating a trial for this population. Given the continued
requests we receive from clinicians to help them treat immunocompromised patients, we are confident that a successful clinical trial
can help deliver an important new potential alternative for these patients."
Buchwald, MD, PhD, an Assistant Professor of Radiation Oncology at Winship Cancer Institute of Emory University and Principal Investigator
of the trial, noted, "We are thrilled to be able to initiate this trial and pioneer the use of the Alpha DaRT in immunocompromised
patients. As we continue to see the promise of the Alpha DaRT through our participation in the ReSTART trial, it is obvious to us that
we need to use this treatment elsewhere, particularly in populations at risk such as this."
Robert B. Den, Alpha Tau Chief Medical Officer, added, "This trial targets a particularly vulnerable population for whom treatment
options are limited, which affords the ability to provide even more potential value to these patients. We are looking forward to treating
patients in this trial soon."
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.
Alpha Tau Medical Ltd.
in 2016, Alpha Tau is an Israeli oncology therapeutics 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.
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 7, 2024, 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.