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Biotech Daily Dose

FDA Approves IDE Supplement To Expand Alpha DaRT Pilot Trial For Pancreatic Cancer

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Alpha Tau Medical Ltd. (DRTS), an oncology therapeutics company, on Monday, announced that the FDA has granted approval for an Investigational Device Exemption or IDE supplement, expanding its ongoing clinical trial of Alpha DaRT for the treatment of pancreatic cancer.

This supplement allows the inclusion of an additional cohort for locally advanced pancreatic cancer patients, increasing the total number of patients across the two cohorts to 30.

The expanded study will now examine the combination of Alpha DaRT and chemotherapy in patients with newly diagnosed metastatic pancreatic cancer, along with those with locally advanced disease.

The trial will be conducted at up to 10 clinical trial sites across the U.S.

This approval follows the release of promising data regarding disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT.

The IDE supplement marks a significant step forward in Alpha Tau's efforts to explore new treatment options for this aggressive cancer.

CEO Uzi Sofer expressed confidence that the progress of the trial will bring Alpha DaRT closer to offering a potential breakthrough for patients with pancreatic cancer.

Cash Position:

As of September 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits totaling $68.4 million. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

Currently, DRTS is trading at $3.72 up by 0.54%.

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