VentiRx Pharmaceuticals Initiates the ACTIVE8 Phase 2 Clinical Trial Evaluating VTX-2337 in Combination with Cetuximab and Chemotherapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

SEATTLE, July 2, 2013 /PRNewswire/ -- VentiRx Pharmaceuticals, Inc. announced today the initiation of the ACTIVE8 clinical trial, a randomized, placebo-controlled, Phase 2 trial evaluating VTX-2337 in combination with a standard of care regimen, cetuximab, platinum and 5 Fluorouracil (5-FU), in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

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The ACTIVE8 trial will randomize 175 patients to receive either VTX-2337 or placebo in combination with cetuximab, platinum and 5-FU chemotherapy. The primary endpoint of the trial will be progression-free survival as determined by Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). The study will be conducted in approximately 50 centers throughout the U.S. More information on this trial is available at clinicaltrials.gov (NCT01836029).

VTX-2337 is a novel small molecule Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system. This includes activation of human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive anti-tumor responses.

Results from preclinical models suggest that combining VTX-2337 with some chemotherapies and monoclonal antibodies demonstrate a synergistic effect in stimulating a variety of immune pathways associated with anti-tumor activity including antibody-directed cellular cytotoxicity (ADCC). Early data from an ongoing Phase 1 trial in squamous cell carcinoma of the head and neck (SCCHN) demonstrated that the combination was safe and well-tolerated, and demonstrated activation of NK cells following dosing with VTX-2337.

"We are very pleased that VentiRx has initiated this trial that gives us the option of combining VTX-2337 with a current standard of care treatment in the first-line setting of recurrent head and neck cancer," said Ezra Cohen M.D. study co-chair and Associate Professor of Medicine at The University of Chicago. "Given the preclinical and early clinical data with VTX-2337 in SCCHN, we are hopeful that ACTIVE8 will provide meaningful benefits in this population who currently have few treatment options."

"We are excited to initiate our second randomized, placebo-controlled, Phase 2 study with VTX-2337 in a second solid tumor indication," said Robert Hershberg, M.D., Ph.D., President and Chief Executive Officer of VentiRx. "The ACTIVE8 study in head and neck cancer patients focuses on the ability of our novel TLR8 agonist to stimulate NK cells, ADCC and monoclonal antibody responses. This study complements the ongoing GOG-3003 study in combination with pegylated liposomal doxorubicin (PLD) chemotherapy in patients with ovarian cancer."

ACTIVE8 will be the second randomized Phase 2 clinical trial evaluating VTX-2337 in the treatment of advanced cancers. The first trial was initiated in collaboration with the Gynecologic Oncology Group to investigate whether combining VTX-2337 with PLD, standard second-line chemotherapy for ovarian cancer patients, has the potential to improve overall survival compared to PLD alone. This trial (GOG-3003, NCT01666444) is currently enrolling patients at 65 sites in the U.S.

About VentiRx Pharmaceuticals

VentiRx Pharmaceuticals Inc. is a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8)   immunotherapies for the treatment of cancer.  The Company's lead product candidate is VTX-2337, a small molecule TLR8 agonist for the treatment of various solid tumors. VentiRx has an exclusive, world-wide collaboration with Celgene Corporation for VTX-2337. VentiRx is a privately held organization based in Seattle, Washington. For additional information, please visit www.ventirx.com.

SOURCE VentiRx Pharmaceuticals, Inc.