Small Biz Grant to Advance Cancer Chemotherapy Patch

(Nick Youngson, Picpedia.org)

24 Aug. 2021. A medical device company is receiving a small business grant from NIH to commercialize a patch that delivers chemotherapy directly to oral tumors. National Institute of Dental and Craniofacial Research, part of National Institutes of Health, awarded Privo Technologies Inc. in Peabody, Massachusetts some $3 million over three years to complete commercialization steps for its PRV111 patch device.

Privo Technologies develops systems for local delivery of cancer chemotherapy drugs given systemically in most cases, often resulting in adverse effects for patients. The company says its technology, called Program Release Vehicle or PRV, provides a process for keeping cancer drugs stable while stored in a patch or hydrogel, then released at a rate and location in response to conditions in the patient. The company’s lead product, code-named PRV111, is a patch for delivering chemotherapy drugs directly to head, neck, and oral cancers.

Privo Technologies cites data from the Oral Cancer Foundation showing more than 51,000 Americans are expected to be diagnosed with oral and pharyngeal cancer this year, resulting in more than 10,000 deaths. Worldwide, some 840,000 cases are expected this year, leading to 480,000 deaths. The company says oral cancer surgery can lead to facial disfigurement, permanent speech impairment, loss of ability to swallow, and loss of jawbone. Because of these physical disabilities from surgery, says Privo Technologies, oral cancer patients experience one of the highest suicide rates among all cancer patients.

PRV111 is a patch placed on the oral tumor. The patch is designed to release particles of the chemotherapy drug cisplatin directly into the tumor to kill cancer cells, as well as in nearby lymph nodes. In June, Privo Technologies reported results from 12 patients with oral squamous cell carcinoma in an early- and mid-stage clinical trial.

Tumor reductions of 70 percent

The findings show after four treatments, some 300 and 100 times higher concentrations of cisplatin in oral tumors and lymph nodes respectively for PRV111 recipients, than patients receiving cisplatin intravenously. In addition, 10 patients reported response rates of 87 percent, with tumor reductions of 70 percent after seven days. The company says no recurrences of cancer occurred within six months, and no dose-limiting toxicities, serious adverse event, or systemic toxicities were reported.

“Here at Privo,” says company CEO Manijeh Goldberg in a statement, “we seek to transform the standard of care for patients suffering from mucosal cancers that typically require disfiguring and disabling surgeries. By alleviating the safety concerns with traditional chemotherapies, our lead asset facilitates locoregional sequestration of the chemotherapeutic to the tumor site and has demonstrated superior efficacy and safety profiles in comparison to standard chemotherapies.”

The award from NIDCR is a Commercialization Readiness Pilot grant designed to help small businesses complete the steps for taking their health care products to market. The funds are expected to upgrade Privo Technologies’ manufacturing facilities to meet Good Manufacturing Practice standards, expand its patents, conduct market research, and develop strategies for pricing and insurance reimbursement. The company says it’s also preparing for a late-stage clinical trial of PRV111.

Commercialization Readiness Pilots are follow-on awards to standard phase 1 and 2 Small Business Innovation Research or SBIR grants for developing new health care technologies. Privo Technologies says it’s also raising $3 million in matching funds for commercializing PRV111.

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