The US FDA had earlier granted Breakthrough Designation for treating advanced or metastatic cancer patients, who are unresponsive to standard of care therapy
Image: The IDE approval from FDA is subject to the clinical trial Informed Consent documents approval. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
US-based therapeutic medical device company Aethlon Medical has secured the US FDA Investigational Device Exemption (IDE) approval to start an Early Feasibility Study (EFS) of its Hemopurifier.
Aethlon said that the EFS for a medical device is similar to the phase 1 study for a drug and involves enrolling a small number of patients with advanced head and neck cancer, and cannot be treated with surgery or radiation.
Aethlon CEO Timothy Rodell said: “This IDE approval is a critical first step in our plans to develop the Hemopurifier for applications in oncology. We believe that the clearance of immunosuppressive tumor-derived exosomes has the potential to improve response rates to these already game-changing immuno-oncology agents.
“Our Breakthrough Designation has allowed us to move very quickly with rapid, frequent and helpful communication with the FDA and clearly demonstrates the value of the Breakthrough program.”
The EFS is intended to evaluate Hemopurifier device in patients with head and neck cancer in addition to the standard of care pembrolizumab (Keytruda), and is expected to enrol 10-12 subjects, at a single centre.
Hemopurifier secured Breakthrough Designation from FDA in 2018
In November 2018, the US FDA has granted Breakthrough Designation to Hemopurifier for treating advanced or metastatic cancer patients, who are unresponsive to standard of care therapy, and with cancer types that exhibit participation of exosomes in the development or severity of the disease.
The Hemopurifier also has Breakthrough Device designation for life-threatening viruses that are not addressed with approved therapies.
Safety is the primary endpoint of the EFS, while the measures of exosome clearance and characterization, along with response and survival rates are the secondary endpoints.
Aethlon Medical said that the previously conducted non-clinical studies demonstrated that Hemopurifier clears the primary mechanism of resistance to pembrolizumab and other immuno-oncology drugs, caused by the tumour cells of exosomes.
The IDE approval from FDA is subject to the approval of Informed Consent documents from the clinical trial.