An Israeli breakthrough in radiation treatment for cancer with a 100-percent success rate in the initial pilot trials has made it to Phase 3 pivotal trials just ahead of expected approval from the FDA, according to a report released by “NoCamels” and published in the Journal of the American Medical Association.
The Jerusalem-based startup, Alpha TAU, is expanding its trials of the treatment for mainly skin cancer after its first trial of 10 patients succeeded far beyond the company’s, or frankly beyond anyone's expectations. The pilot trial strictly pin-pointed its studies on patients whose cancer was “unresectable or recurrent, who have no standard of care,” Alpha TAU CEO, Uzi Sofer, told reporters.
$DRTS Alpha Tau Announces the Publication of its US Multicenter Pilot Skin Cancer Trial Results in JAMA Network Open https://t.co/c8eGsU4am6
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“Those patients got 100% complete response,” Sofer added. The pilot trial, handled at multiple locations throughout the US in 2022, examined how Alpha TAU’s diffusing alpha-emitters radiation therapy technology could successfully produce targeted radiation therapy for patients with malignant skin and superficial soft tissue tumors that had come back or could not be removed with standard surgery procedures.
Alpha TAU was hoping that their treatment would be successful in 70% of the trial participants but instead registered successful delivery to all 10 cancer patients. CT scans showed a 100% response rate after 12 weeks and again at 24 weeks, with no evidence of cancer returning in any way, shape, or form. The trial also observed side effects from the radiation treatment, along with the stability of the device once placed inside the tumor and any other impact on the quality of life of the patients.
$DRTS is up 14.88% as Alpha Tau Medical's pilot trial demonstrated a 100% Complete Response rate with no adverse events or toxicity in 10 patients treated with Alpha DaRT for skin cancer. #stockmarkethttps://t.co/p7MBTtujcu
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The findings of the pilot trial have already been published earlier this month in the Journal of the American Medical Association, just months after submitting the results to the FDA. The treatment is now undergoing its final pivotal trial, which hopefully will result in the FDA stamp of approval. “We submitted the results that you see now to the FDA, and the FDA told us that we can submit the protocol for the last phase, the pivotal,” Sofer said.
Alpha Tau Announces the Publication of its US Multicenter Pilot Skin Cancer Trial Results in JAMA Network Open $DRTS https://t.co/HuWJtzXP7r
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A pivotal trial is always required by the US and European Union drug agencies in order to receive final approval to market a new form of medication. The Israeli entrepreneur, Uzi Sofer added that the successful findings of the trial have led to medical institutes around the world seeking to work with Alpha TAU, but for now, research is being limited to just a handful of locations for the pivotal trial. “Many, many, many centers all around the world want to participate. We are working with 20 centers in the US, two or three centers in Canada, and another four in Israel that are going to participate in this trial.”
