New Treatment for Patients with Advanced Head and Neck Cancer in Phase I Clinical Trial
STAT3 is a major signaling protein in cells. It is hyperactivated in over 50% of cancers including head and neck cancer. This results in abnormal cell growth, escape from our immune system, metastasis (spreading), and other cancer-associated processes. The development of drugs to target STAT3 effectively has been a challenge for the research community, earning it the label of ‘undruggable’.
Ronald DePinho, M.D. and his colleagues used computer-based drug screening of hundreds of thousands of compounds to identify several candidates that inhibit STAT3 protein when tested in complex tumor models of breast and other various cancers.
NFCR support facilitated the final studies of the most promising inhibitor of STAT3. The inhibitor drug is currently treating patients in an ongoing Phase I clinical trial to establish its safety and appropriate dose. Patients with advanced head and neck cancer and other advanced cancers may be eligible to enroll in the trial of this new treatment.
Novel Nano-technology for Safe and Effective Local Delivery of Potent Treatments Will Begin Clinical Trials for Oral Cancers
The standard of care for oral cancer (lip, tongue, mouth, and other nearby tissues) is surgery and radiation. Damage to a patient’s ability to speak, chew, and swallow can be a lifelong hardship. The unfavorable return of cancer faces many patients. Dr. Manijeh Goldberg and her team developed a new nano-technology device to deliver targeted and timely high doses of drugs directly at the tumor site. It eliminates the need for surgery and radiation in many cases and spares patients’ severe drug toxicities throughout the body.
Her team is bringing the pre-surgical version of treatment to oral cancer patients. Phase I and II clinical trials demonstrated 87% and over 70% reduction in tumor volumes, respectively. Patients also experienced a robust immune response. NFCR’s support is facilitating a Phase III clinical trial for oral cancer patients set to begin soon. This trial will use two versions of the technology: PRV111 – the pre-surgery version applied topically to the tumor site, and PRV211 – a post-surgical version placed directly to the tumor site and or lymph nodes to rapidly destroy remaining cancer cells. These promising nano-technologies can deliver different types of therapeutics and can treat numerous types of other cancers.
Treatment in Clinical Trials for non-Hodgkin T-cell Lymphoma Shows Promise in Head and Neck Cancer Pre-Clinical Studies
Fenretinide, a drug similar in structure to Vitamin A, may offer patients non-Hodgkin T-cell Lymphoma a life-saving treatment. Previously, former NFCR-funded scientist, Dr. Michael Sporn, researched fenretinide and proved its safety in humans for other cancers. Subsequently, the drug demonstrated safety and effectiveness in patients. non-Hodgkin T-cell Lymphoma is toxic to cancer cells by activating the cell suicide pathway (apoptosis). Scientists have discovered fenretinide reactivates the immune system to complement apoptosis and it is effective in models of non-Hodgkin T-cell Lymphoma, head and neck cancer and other cancer types. Fenretinide will soon begin Enrollment in the Phase 1 trial for non-Hodgkin T-cell Lymphoma patients. NFCR’s support for SciTech helped develop a unique delivery system for fenretinide and gain FDA approval to treat non-Hodgkin T-cell Lymphoma patients who no longer respond to their current therapy. Success in clinical trials for these patients will facilitate a future clinical trial for patients with head and neck cancers.