Jerusalem based Alpha Tau Medical Ltd. TM (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy, announced that all ten patients in its US multicenter pilot trial of the Alpha DaRT TM for malignant skin soft tissue cancers have reached the secondary endpoint for measurement of tumor response. The study met its primary feasibility endpoint, as all patients had successful delivery of radiation by Alpha DaRT TM. At approximately 12 weeks, all ten tumors demonstrated a complete response, defined as disappearance of the treated tumor, as measured using RECIST v.1.1 criteria, and the safety profile has been consistent with the company’s other clinical trials, with no product-related adverse events observed to date.
Alpha Tau CEO, Uzi Sofer, remarked, “Alpha Tau is incredibly focused on the US market, which we see as the paramount market for Alpha DaRT. We have been successful thus far in demonstrating promising results around the world, but it was critical for us to generate data such as this in the US as well, and we are very excited about the efficacy and safety data observed. The data from this trial gives us tremendous confidence and brings us closer to the US multi-center pivotal trial for skin cancer, which we are currently planning for 2022, and for which we are already seeing enormous interest from leading clinicians and trial sites in the U.S. and around the world.”
“We are extremely encouraged by the initial efficacy results from our US pilot trial,” said
Alpha Tau CMO, Dr. Robert Den. “This highlights the potential impact that Alpha DaRT can have on the management of trial patients with skin malignancies, and contributes to the increasing clinical evidence supporting the use of the Alpha DaRT. We look forward to continued examination of the potential of the Alpha DaRT backed by the expediency of the FDA’s breakthrough device designation.”
“This clinical trial was designed to demonstrate the feasibility and safety of the Alpha DaRT,” added Principal Investigator, Dr. Chris Barker of Memorial Sloan-Kettering Cancer Center in New York. “Through collaborative efforts, the trial has progressed despite a year of challenging circumstances. We are optimistic about future opportunities to develop innovative treatment strategies with Alpha Tau.”
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.
Japanese Clinical Trial
Alpha Tau announced on December 31, 2021 that it has been notified by HekaBio K.K, its clinical trial partner in Japan, that recruitment has been completed in its open-label multicenter pivotal study evaluating the Alpha DaRT in Japanese patients with recurrent head & neck cancer after radiotherapy.
HekaBio has reported that preliminary results of this trial are highly encouraging and that it will continue compilation and analysis of the data in collaboration with its medical experts, in an effort to prepare a submission seeking marketing approval via the Shonin (Japanese regulatory pathway for pre-market approval application of medical devices) in consultation with Japanese authorities.
Alpha Tau CEO, Uzi Sofer, remarked, “This is an important milestone for Alpha Tau as we look to bring our unique Alpha DaRT therapy to patients around the world. Having secured our first marketing authorization in Israel, we look forward to seeing pivotal trial data from Japan, with an eye toward initiating a pivotal trial in the U.S. in 2022. Japan is an important market for Alpha Tau, and we appreciate the untiring efforts of HekaBio CEO Rob Claar and his team, as well as all of the investigators from leading cancer centers in Japan who have participated in this trial.”
Merger Agreement with Healthcare Capital Corp. (Nasdaq: HCCC)
In July 2021, Alpha Tau announced that it had entered into a definitive 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 with HCCC and become a Nasdaq-listed public company.
Media package: https://www.alphatau.com/media-package.
Dr. Stephen M. Hahn, former Commissioner of the FDA, who served as due diligence advisor to HCCC in its announced business combination with Alpha Tau, commented, “I am very impressed with the results of the feasibility trial of the Alpha DaRT. Achieving a 100 % complete response rate for new cancer therapy with no product-related serious adverse events is remarkable.”
Dr. Hahn added, “As a medical and radiation oncologist, I believe the opportunity is compelling for the Alpha DaRT to offer new hope to numerous patients with difficult to treat solid tumors throughout the body, and this news is more evidence supporting that view.”
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is a Jerusalem-based 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 Professor Itzhak Kelson and Professor Yona Keisari of Tel Aviv University.
The company, which is currently conducting trials to treat many other types of cancer including breast, oral cavity, pancreas, neck, and brain tumors, has 90 employees in Israel and operates a production line in Jerusalem. The company has several dozen more employees in the U.S. and Japan where its products are in advanced stages of receiving approval. Alpha Tau is building plants in both countries.
Source: PR Newswire
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