Breakthrough Turmeric Clinical Trial: PHASE ONE Grant Fuels Hope for Less Toxic Oral Cancer Treatment

PHASE ONE Foundation is excited to award the Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) an $80,000 Medical Grant to fund a breakthrough turmeric clinical trial. The Phase II trial, led by Dr. Marilene B. Wang, will investigate the efficacy of a turmeric pastille, APG-157, in treating oral and oropharyngeal cancers.

Oral and oropharyngeal cancers often present at advanced stages, and traditional treatments such as surgery, radiation, and chemotherapy can result in significant morbidity and poor prognosis. The need for innovative and less harmful treatment options is paramount.

This study aims to explore a potentially less toxic and more effective treatment modality for head and neck cancers, particularly those affecting veterans who are at higher risk due to elevated rates of smoking and HPV infection.

"This new project represents a promising innovation in cancer therapy that will particularly benefit Veterans with oral and oropharyngeal cancers. GLAVREF is excited to partner with PHASE ONE in support of this research.”–Dr. Jennifer L. Martin, GLAVREF Board of Directors Chair

Curcumin, derived from the rhizome of the Curcuma longa plant, has long been used in traditional Indian (Ayurvedic) and Chinese medicine for its medicinal properties. Curcumin, along with other curcuminoids found in turmeric, has been extensively researched for its anti-carcinogenic and chemopreventive effects.

Studies have demonstrated that curcumin can suppress the proliferation of various tumor cells, including those found in breast, colon, lung, melanoma, myeloma, leukemia, and prostate carcinomas. This multi-pathway targeting capability makes turmeric a compelling candidate for cancer treatment.

Dr. Wang and her team have conducted pre-clinical studies demonstrating turmeric’s significant suppressive action on head and neck cancers. A recent Phase I trial of the turmeric pastille used in this trial confirmed its safety and demonstrated its potential to reduce inflammatory cytokines in saliva, decrease tumor-associated microbes, and recruit T-cells to the tumor microenvironment in patients with oral cancer.

With support from PHASE ONE, the Phase II trial will expand on these findings. APG-157 contains a full spectrum of turmeric's active constituents, including curcumin, and is expected to induce apoptosis in tumor cells, thereby reducing tumor burden and enhancing outcomes from subsequent local therapy. The study will evaluate APG-157's efficacy by examining pathological responses, immune response biomarkers in saliva and blood, and changes within the tumor tissue of patients with Head and Neck Squamous Cell Carcinoma (HNSCC).

"It is so rewarding to see the progression of our research from pre-clinical studies in the laboratory, which demonstrated curcumin’s anticancer properties, to a clinical trial for patients with oral cancer.  We are very encouraged by our preliminary data and look forward to enrolling more patients in this trial, in hopes of developing more effective and less toxic cancer treatments.” –Dr. Marilene B. Wang, Principal Investigator

This open-label trial will enroll 24 patients with biopsy-proven oral or oropharyngeal cancer. Participants will receive APG-157, a turmeric pastille, at a dosage of 200 mg three times a day for 4 weeks, prior to their definitive treatment with surgery or radiation. Weekly blood draws and saliva samples will be collected to study pharmacokinetic data, toxicity, cytokines, and the microbiome.

Should this study prove successful, it could revolutionize the treatment landscape for oral and oropharyngeal cancers, offering a new, less toxic therapy that improves patient survival rates and quality of life. This could particularly benefit high-risk populations, such as veterans, by providing an effective alternative to traditional treatments that often come with severe side effects.

"PHASE ONE's mission is to fund and accelerate innovative clinical cancer research to improve treatment outcomes. This trial aligns perfectly with our goals, offering hope for a novel treatment approach that could make a real difference in patients' lives.” –Dr. Amanda Salvado, PHASE ONE Granting Co-Chair