Jerusalem-based Alpha Tau Medical Ltd. “Alpha Tau”, (NASDAQ: DRTS, DRTSW), has announced that up to 86 patients are to be enrolled in the U.S., Canada, Europe and Israel to assess the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma. The first two patients were enrolled and treated last month in its pivotal multicenter trial, known as the ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The patients were treated at the University Cancer Center in Houston, Texas
Alpha Tau is also carrying out clinical trials in Canada of patients who have Stage II, III, or IV pancreatic cancer. Its first patient with advanced inoperable pancreatic cancer has been treated at the beginning of April 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.
Alpha Tau CEO Uzi Sofer commented, “The ReSTART trial marks an important milestone for the Company and paves our path forward towards our ultimate goal of U.S. regulatory approval. Moreover, being able to enroll the first two patients simultaneously in one site demonstrates the high unmet need in this patient population and is an important boost in our recruitment efforts. We are hopeful that the results of this study, together with the Breakthrough Device Designation from the FDA for the treatment of this indication, will allow us to gain FDA approval and make the Alpha DaRT treatment available as quickly as possible for patients who suffer from recurrent cSCC. In the coming year, we will continue to focus our efforts on three main areas: swift recruitment in the ongoing ReSTART study, targeting initial results from our internal organ clinical program such as the treatment of pancreatic and prostate cancers, and continued scale-up of our production capacity to allow for smooth and efficient production.”
The ReSTART trial at the University Cancer Center in Texas is intended to enroll up to 86 participants who have biopsy-proven recurrent cSCC who are not otherwise indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. The primary study endpoints include an overall objective response rate, based on the best overall response, duration of response at 6 months from the initial observation of response to Alpha DaRT insertion, and safety of the Alpha DaRT treatment. The study’s secondary objectives are to assess the progression-free survival and overall survival at 1 year following Alpha DaRT treatment, the overall duration of response, local control, and quality of life. Additional information about the trial can be found at https://clinicaltrials.gov/ct2/show/NCT05323253.
Interview with patients who underwent Alpha Dart treatment https://www.youtube.com/watch?v=t2MXPoS5ql4
“We remain committed to bringing new hope to patients in this very difficult-to-treat population. We would like to thank Dr. Mark D’Andrea and Dr. Lawrence Clarke and the dedicated staff at University Cancer Center in Houston for enrolling and treating the first patients in the ReSTART trial and look forward to the forthcoming results,” said Alpha Tau Chief Medical Officer, Dr. Robert Den.
Dr. Mark A. D’Andrea, the radiation oncologist at University Cancer Center in Houston, commented, “I believe that Alpha DaRT can be a real breakthrough in the treatment of recurrent cSCC. These patients have exhausted the effective treatment options available to them, and Alpha DaRT may give these patients additional hope for a successful outcome. In my experience as a radiation oncologist, treatment with the Alpha DaRT is a quick and straightforward procedure that can often be done in the office setting or procedure room in the clinic without the need for hospitalization or a shielded radiation suite. The procedure is often done using a local anesthetic, with the patient returning after 2 weeks for the removal of the sources. The patient should then be able to return to a normal daily routine quickly.”
The clinical trials in Canada seek to recruit 30 participants who have Stage II, III, or IV pancreatic cancer and who have a pancreatic tumor that 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). Read more about the trial. 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 (the Jewish General Hospital) 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.”
Dr. 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 to opening this trial at our hospital and for securing a straightforward procedure for Alpha DaRT insertion into the pancreatic tumor.”
About Alpha Tau
Alpha Tau (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.
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