cisplatin transmucosal patch (PRV111) / Privo Tech - LARVOL DELTA

PRV111, in Development as the First Non-Surgical Therapy for Early-Stage Non-Invasive Oral Cancer and High-Grade Dysplasias, Meets Its Primary Efficacy Endpoint in Ongoing Phase 2/3 Trial (PRNewswire) - "Twelve patients with biopsy-confirmed non-invasive oral cancers or high-grade dysplasia received a single cycle of PRV111. Eleven patients achieved centrally confirmed pathologic CRs; the twelfth patient was down staged to low-grade dysplasia, eliminating the need for surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of ~6 months, no recurrences were observed; several patients have maintained responses beyond six months, and the longest ongoing response now ~12 months."

P2/3 data • Oral Cancer • Squamous Cell Carcinoma

Safety and Efficacy Study of PRV111 and PRV211 in Subjects With Oral Squamous Cell Carcinoma (clinicaltrials.gov) - P2/3 | N=40 | Recruiting | Sponsor: Privo Technologies | Trial completion date: Oct 2026 ➔ May 2027 | Trial primary completion date: Aug 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Privo Technologies Expands CLN-004 Clinical Trial Across Leading U.S. Cancer Centers (PRNewswire) - "Privo Technologies...is thrilled to announce the activation of multiple premier clinical sites across the United States for its ongoing CLN-004 trial. This Phase 2/3, open-label, two-arm study is evaluating the safety and efficacy of two of Privo's lead assets-PRV111 and PRV211-in patients with head and neck squamous cell carcinoma (HNSCC)....Additional leading cancer centers are in the process of being activated and will be announced in the coming weeks."

Trial status • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy Study of PRV111 and PRV211 in Subjects with Oral Squamous Cell Carcinoma (clinicaltrials.gov) - P2/3 | N=40 | Recruiting | Sponsor: Privo Technologies | Phase classification: P1/2 ➔ P2/3

Phase classification • Surgery • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy Study of PRV111 and PRV211 in Subjects with Oral Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Privo Technologies | Trial primary completion date: Jan 2025 ➔ Aug 2025

Surgery • Trial primary completion date • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Privo Technologies, Inc. Announces Publication in Nature Communications (PRNewswire) - "Privo Technologies, Inc...announced that Nature Communications published the results of the evaluation of efficacy and safety data collected using PRV111 on animal models of oral cancer and clinical trial in patients with oral cavity squamous cell carcinoma (OCSCC)....'This data highlights the promise of targeted and local chemotherapy treatment and validates the superior mechanism and design of the PRV Platform and its lead derivative PRV111. This data serves as a critical milestone for entering into a Phase 3 clinical trial for patients with Carcinoma in Situ of the oral cavity as well as a springboard for exploring the use of the platform in other mucosal cancers such as lung, cervical, vaginal, rectal, and anal cancers'."

Clinical data • Preclinical • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor

A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer. (PubMed, Nat Commun) - P1/2 | "Despite therapeutic advancements, oral cavity squamous cell carcinoma (OCSCC) remains a difficult disease to treat. No locoregional recurrences were evident in 6 months. Integration of PRV111 with current standard of care may improve health outcomes and survival of patients with OCSCC."

Journal • Preclinical • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Privo Technologies Receives U.S. FDA Orphan Drug Designation (PRNewswire) - "Privo Technologies, Inc...announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Privo's PRV platform delivery of cisplatin for the treatment of carcinoma in situ (CIS) of the anterior 2/3 of the oral cavity."

Orphan drug • Oncology

CLN-001: Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2; N=10; Completed; Sponsor: Privo Technologies; Recruiting ➔ Completed; N=31 ➔ 10

Clinical • Enrollment change • Trial completion • Oncology • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A phase II study of PRV111 nanoengineered cisplatin patch as a neoadjuvant therapy for early-stage oral squamous cell carcinoma (OSCC). (ASCO 2021) - P1/2 | "Adding neoadjuvent PRV111 to the care for patients with OSCC may improve the surgical outcome and increase event free survival . Given these encouraging results, future studies are needed to establish the application of this non-invasive platform in head and neck SCC and other epithelial cancers, including anal, colorectal, genitourinary, nasal, and skin."

Clinical • P2 data • Immune Modulation • Immunology • Inflammation • Oncology • Oral Cancer • Pain • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Privo Technologies, Inc. to Present Phase II Data for PRV111 in Head and Neck Squamous Cell Carcinoma at the Upcoming 2021 ASCO Annual Meeting (PRNewswire) - "Privo Technologies...announced today a poster presentation on the safety and efficacy of PRV111 in patients with early-stage Head and Neck Squamous Cell Carcinoma (HNSCC). PRV111 is an anticancer topical patch that allows for locoregional treatment. The poster presentation will be available at the 2021 ASCO Annual Meeting being held June 4-8, 2021."

P2 data • Head and Neck Cancer • Oncology • Oral Cancer