Alpheus Medical Treats First Patients in First-In-Human Clinical Trial for Novel High-Grade Glioma Brain Cancer Treatment

Milestone arrives as the company closes a $14 million follow-on Series A financing round to expand the clinical program for high-grade gliomas, including glioblastomas, and pursue additional indications

OAKDALE, Minn., Nov. 10, 2022 /PRNewswire/ -- Alpheus™ Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, today announced the treatment of the first three patients in the U.S.-based multi-center Phase 1 clinical trial evaluating the safety and optimal dosage of the company's proprietary platform.

The milestone coincides with the announcement that the company nearly doubled their recent Series A investment and closed a $14 million follow-on round with existing investor participation from OrbiMed Advisors, Action Potential Venture Capital, the Medtech Convergence Fund, an SV Health Investors venture fund, and BrightEdge, the impact investment and venture capital arm of the American Cancer Society. Driven by a successful pre-clinical program, the new investment will be used to expand cohorts in the first-in-human (FIH) clinical trial, initiate an additional clinical trial internationally, and pursue indications for other non-brain, solid body cancers.

"Conventional therapy options for patients with high-grade glioma, including glioblastoma, are limited and innovation in the field has too long been stagnant, leaving patients with poor outcomes and significant tradeoffs in quality of life. By non-invasively targeting and eradicating tumor through the entire brain hemisphere, Alpheus' novel SDT platform represents a potential paradigm shift in the fight against this disease," stated Michael Schulder, MD, Director of the Brain Tumor Center at Northwell Health's Institute for Neurology and Neurosurgery. "We are excited to be part of this important clinical trial and look forward to following these patients as we evaluate the therapy." 

"The heterogeneous, diffuse nature of gliomas behind the blood-brain-barrier (BBB) is preferably treated with a repeatable, large-field therapy that can extend beyond the borders of the visible tumor to eradicate the highly invasive cancer cells," remarked Tanner M. Johanns, MD, Assistant Professor of Medical Oncology at Washington University School of Medicine in St. Louis. "Alpheus' non-invasive SDT therapy aims to overcome both challenges with a safe, repeatable therapy that targets only cancer cells." Dr. Johanns and Dr. Schulder are primary investigators in the Alpheus trial.

Alpheus Medical's investigational SDT treatment includes an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire brain hemisphere using low-intensity, large-field ultrasound. The treatment can be done in an outpatient setting, allows for repeat treatment, and does not require the use of imaging, such as MRI.

The FIH Phase 1 multi-center trial (NCT05362409) is designed to study the safety and optimal dosage of Alpheus' SDT treatment and is planned to enroll up to 33 patients. The trial is currently enrolling patients with high-grade gliomas, including glioblastomas, across three sites, including Northwell Health's North Shore University Hospital (greater New York City, NY), Washington University in St. Louis (St. Louis, MO), and Dent Neurologic Institute (Buffalo, NY).

"Thanks to our clinical and investor partners, we are building a company that is poised to revolutionize the treatment of brain cancer with our non-invasive, repeatable SDT platform," stated Dr. Vijay Agarwal, CEO and founder of Alpheus Medical and a practicing brain tumor surgeon in New York City. "These milestones follow our recent Orphan Drug and Fast Track Designations from the FDA and build momentum as we work towards advancing this novel technology to market for the treatment of high-grade gliomas and other solid body tumors."

Alpheus Medical, Inc, is a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers. The company's lead product utilizes a novel, non-invasive drug-device combination for the outpatient treatment of recurrent high-grade gliomas, including glioblastomas. Alpheus Medical's work has been developed in conjunction with some of the most accomplished names worldwide in neuro-oncology. In addition, the Alpheus investor group includes prominent health investors such as OrbiMed Advisors, Action Potential Venture Capital, and the Medtech Convergence Fund, an SV Health Investors venture fund, as well as prestigious cancer-focused organizations including BrightEdge, the impact investment and venture capital arm of the American Cancer Society, and the National Brain Tumor Society. The therapy is currently in early clinical stage use and is not yet commercially available. Learn more at www.alpheusmedical.com.

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SOURCE Alpheus Medical, Inc