Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 134

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 134
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of a clinical investigation from the French Ministry of Health, we are also working to initiate a clinical study at a single center in
France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.
The primary objective of the study will be to evaluate the feasibility of the Alpha DaRT for the treatment of locally advanced pancreatic
cancer, and the primary endpoint is Alpha DaRT insertion feasibility. Other endpoints include local control rate according to RECIST v.
1.1 criteria, and the incidence of AEs and treated-related AEs.

Prostate Cancer

According to the
American Cancer Society, prostate cancer is the second most frequently diagnosed cancer in men worldwide, and according to the
International Agency for Research on Cancer, approximately 1.5 million new cases are diagnosed each year. We believe there are
several potential benefits to delivering neoadjuvant radiation therapy specifically with Alpha DaRT in patients with prostate
cancer. First, we believe that Alpha DaRT may be able to elicit an immune response, as suggested by previous pre-clinical data that
showed immune activity, as well as data from our clinical studies that showed anecdotal evidence of a potential abscopal effect,
which we believe would have the potential to inhibit the development of future metastases. Second, while prostate cancer is a
heterogeneous disease, it appears that local recurrences emanate from the dominant lesion. Therefore, we believe treating these
lesions with Alpha DaRT could decrease the risk of recurrence. Third, these dominant lesions can create hypoxic microenvironments,
which are associated with worse outcomes for traditional radiation therapy. Alpha radiation cytotoxic activity has been observed to
be independent of oxygen levels and therefore we believe may be better suited to treating these lesions. While our first study
focuses on evaluating neoadjuvant use of Alpha DaRT in treating prostate cancer, we have also initiated a study to evaluate Alpha
DaRT for focal treatment of radiation recurrent tumors.

Rambam Health Care Campus / Carmel
Medical Center, Israel (recruiting)

We have initiated a clinical
study at the Rambam Health Care Campus and Carmel Medical Center in Israel, to investigate the feasibility and safety of evaluating neoadjuvant
use of Alpha DaRT in treating prostate cancer. The trial will recruit up to 10 patients with previously untreated, non-metastatic, resectable
prostate adenocarcinoma, who will receive