Alpha Tau Announces Completion of Enrollment in First US Clinical Trial of Alpha DaRT™ and Achievement of First Primary Objective

Rhea-AI Summary

Alpha Tau Medical has completed enrollment for its U.S. pilot trial of the Alpha DaRT cancer therapy aimed at treating skin cancer, reaching this milestone within four months of the first patient recruitment in July 2021. The trial's primary objective was to demonstrate the feasibility of successfully delivering Alpha DaRT, and all patients had successful implantations and removals without serious adverse events. The treatment-related adverse events observed thus far align with previous trials. The next assessment of tumor response will occur three months post-removal. Alpha Tau aims to progress toward a pivotal trial in 2022.

Positive

• Completion of enrollment in the U.S. pilot trial for Alpha DaRT.
• All patients had successful implantations and removals of Alpha DaRT sources.
• No serious adverse events were reported during the trial.

Negative

• None.

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

FAQ

What is the purpose of the U.S. pilot trial for Alpha DaRT?

The trial is designed to evaluate the feasibility of the Alpha DaRT for treating skin cancer, focusing on the successful delivery and monitoring of treatment-related adverse events.

When did patient recruitment for the trial begin?

Patient recruitment for the trial began in July 2021.

What were the primary objectives of the trial involving HCCC?

The primary objectives were to demonstrate the feasibility of delivering Alpha DaRT to at least seven out of ten patients and to assess the frequency and severity of acute adverse events.

What are the next steps after the pilot trial for Alpha Tau Medical?

Alpha Tau Medical aims to move into a pivotal trial in 2022 to advance Alpha DaRT toward availability for patients.

How does Alpha DaRT work?

Alpha DaRT uses alpha radiation to target and destroy tumor cells while sparing surrounding healthy tissue, by delivering radium-224 sources directly into the tumor.