Alpha Tau Medical Ltd. (DRTS) has received FDA approval for an Investigational Device Exemption (IDE) supplement, allowing the company to expand its ongoing IMPACT pilot study of Alpha DaRT in pancreatic cancer to include patients receiving Gemcitabine with Abraxane (nab-paclitaxel).
Pancreatic cancer remains one of the most aggressive and difficult-to-treat solid tumors, with limited treatment options and poor survival outcomes. Alpha Tau is evaluating whether its Alpha DaRT, an intratumoral alpha-radiation therapy, can be safely combined with standard chemotherapy to improve outcomes for patients with newly diagnosed unresectable or metastatic disease.
The IDE supplement enables the enrolment of 10 additional patients- five with unreseactable locally advanced pancreatic cancer and five with unresectable locally advanced pancreatic cancer and five with metastatic disease- who will receive Alpha DaRT alongside Gemcitabine/ nab-paclitaxel.
This expansion builds on the prior approval to enroll 30 patients treated with Alpha DaRT plus mFOLFIRINOX, bringing the total planned enrolment to 40 patients.Alpha Tau said the IMPACT study remains a key part of its broader strategy to advance Alpha DaRT in cancers with high unmet need. While recruitment has been strong, the company now expects enrolment to complete in Q3 2026, instead of Q2, to allow time for site approvals and the addition of new patients.
The company's Chief Medical Officer, Dr. Robert Den, noted that expanding the trial to include both leading first-line chemotherapy regimens- mFOLFIRINOX and Gemcitabine/ nab-paclitaxel- provides a broader development path for evaluating Alpha DaRT in both locally advanced and metastatic settings.
The IMPACT trial will assess feasibility, safety, and early signs of efficacy, including tumor response, time to local progression, progression-free survival, and patient-reported pain outcomes. Patients will continue receiving their standard-of-care chemotherapy throughout the study, with Alpha DaRT sources implanted directly into the primary tumor using ultrasound-guided endoscopy.
DRTS has traded between $2.50 and $8.60 over the past year. The stock is currently trading at $8.09, 0.12%.
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