SEATTLE--(BUSINESS WIRE)--VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) agonists for the treatment of cancer, respiratory and autoimmune diseases, today announced the presentation of results from a Phase 1 clinical trial of VTX-2337, a selective TLR8 agonist in patients with advanced solid tumors. Data were presented at the American Society of Clinical Oncology Annual Meeting in Chicago, IL.
The multi-center, open-label clinical trial enrolled 33 patients with advanced solid tumors and was designed to evaluate the safety, pharmacology and biologic activity of single-agent VTX-2337. Patients received treatment at one of eight dose levels, ranging from 0.1 to 3.9 mg/m2, with VTX-2337 administered once weekly for three weeks out of a four-week cycle. Patients received two cycles (six doses) of treatment. Endpoints of the trial included safety and identification of dose-limiting toxicities, pharmacokinetics, pharmacodynamics and determination of maximum tolerated dose.
Overall, VTX-2337 was well-tolerated, with the most common drug-related adverse events being mild to moderate in severity and including injection-site reactions and transient flu-like symptoms. The maximum tolerated dose of VTX-2337 was established to be 3.9 mg/m2. In addition, pharmacodynamic effects—as measured by a defined panel of biomarkers identified in preclinical studies—provide evidence of the biological activity of VTX-2337 in stimulating an innate immune response in cancer patients.
Twenty five percent of patients (N=8) treated with VTX-2337 experienced disease stabilization based on RECIST criteria at eight weeks. Patients with disease stabilization at eight weeks received additional doses of VTX-2337, ranging from 1 to 6 additional cycles (3 to 18 additional doses), until disease progression. One patient with metastatic melanoma demonstrated tumor regression after cessation of VTX-2337 remains disease free at 18 months post-treatment.
“The favorable safety profile, immune response data and early signs of clinical activity from this initial clinical trial of VTX-2337 are very encouraging,” said Peter Cohen, M.D., Senior Associate Consultant in Oncology at the Mayo Clinic and a co-principal investigator of the trial. “We look forward to the continued advancement of this novel product candidate, including its evaluation in combination with existing cancer treatments.”
“We are very pleased with results from this first clinical trial evaluating a selective TLR8 agonist for the treatment of cancer patients,” said Robert Hershberg, M.D., Ph.D., Executive Vice President and Chief Medical Officer at VentiRx. “Based on these results, we have been able to determine appropriate doses to be used in upcoming Phase 1b/2a studies of VTX-2337 in combination with other anti-cancer agents.”
VentiRx plans to advance a broad clinical development program for VTX-2337, with four clinical studies targeted to begin in 2011. These trials will evaluate VTX-2337 in multiple oncology indications in combination with a variety of anticancer agents, including chemotherapy, monoclonal antibody therapy and radiation therapy.
VTX-2337 is a small molecule TLR8 agonist designed to stimulate myeloid dendritic cell and monocytes and enhance NK cell responses. Preclinical evaluation of VTX-2337 suggests it may play a key role in augmenting the innate arm of the immune system, and serve as a valuable addition to diverse treatment regimens in oncology.
About VentiRx Pharmaceuticals
VentiRx Pharmaceuticals Inc. is a biopharmaceutical company committed to the development and commercialization of novel medicines for the treatment of cancer, respiratory and autoimmune diseases. The Company’s initial focus is on developing small molecule TLR-based product candidates for oncology and allergy. VentiRx is a privately held organization with operations in Seattle and San Diego. For additional information, please visit www.ventirx.com.