Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of February 1, 2016

Leap Therapeutics, a biotechnology company developing novel therapeutics at the leading edge of cancer research, reported its first results of a clinical trial of its lead candidate DKN-01, a monoclonal antibody against the Dickkopf-1 (DKK1) protein. Data from the trial demonstrated meaningful clinical activity in relapsed or refractory cancer of the esophagus or gastro-esophageal junction (GEJ), indications with limited approved therapies. In Part A of the study, the dose escalation phase, three of nine patients achieved a partial response (PR) per RECIST v1.1. In the subset of patients with adenocarcinoma who had received one or two prior lines of therapy, three of four patients achieved a PR. “Patients with relapsed or refractory esophageal carcinoma have an extremely poor prognosis,” commented David Ryan, M.D. Massachusetts General Hospital. “The results from the study of DKN-01 in combination with paclitaxel, while early, provide great encouragement, and we look forward to the data from the next phases of this trial.”

ViroMed has announced the publication of the results from successfully completed phase II clinical study of VM202 for the treatment of critical limb ischemia in the January issue of Gene Therapy. The study, “A phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Trial of the Safety and Efficacy of Plasmid DNA Expressing two Isoforms of Hepatocyte Growth Factor in Patients with Critical Limb Ischemia,” examined 52 patients at 16 hospitals and research centers in the United States and Korea. Results from the clinical study showed VM202 to be safe and well tolerated with clinical benefits in CLI patients. VM202 was intramuscularly injected in four series in the muscle of diseased legs in patients, spaced 2 weeks apart, and observed for 12 months. Patients were randomly divided into three groups of placebo, low-dose (8 mg total), high-dose (16 mg total). While both VM202 treated groups showed better improvement compared to the placebo group, patients treated with high-dose VM202 showed significantly better ulcer healing and tissue oxygenation (TcPO2 levels) than patients from the placebo group. “These positive results are exciting, and VM202 shows great promise for treating patients with this debilitating disease who often have limited therapeutic options,” said Dr. Emerson C. Perin, Director of the Stem Cell Center at the Texas Heart Institute and the principal investigator of the study. “We are looking forward to conducting a phase III trial to better understand the potential of this novel approach, especially in treating non-healing ulcers, which is a serious symptom that often leads to amputation because of the lack of medical therapies available.” 

vTv Therapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, announced the enrollment of the first patients in the company’s phase II LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. An oral, small molecule, TTP273 is a GLP-1R agonist with best-in-class potential. This molecule is the second generation from a path-finder molecule TTP054, and it is anticipated to provide enhanced glycemic control, weight loss and an attractive safety profile for the treatment of type 2 diabetes. The previous phase Ib trial of TTP273 demonstrated robust effects on postprandial and fasting glucose. All doses of TTP273 were safe and well tolerated with no serious adverse events or evidence of gastrointestinal side effects compared to placebo. “Earlier studies of this compound showed that TTP273 has the potential to provide enhanced glycemic control and weight loss without the burden of injections or gastrointestinal side effects seen with GLP-1 biologic agents,” said Steve Holcombe, President and CEO of vTv. The LOGRA study is assessing the safety and efficacy of TTP273 in Type 2 diabetic patients on stable doses of metformin. The study’s primary endpoint is change in baseline in HbA1c at 3 months, with secondary endpoints including body weight, plasma glucose, lipids insulin, lactate, C-peptide, glucagon and GLP. The company anticipates enrolling 156 patients at 26 clinical trial sites throughout the U.S. Topline results are expected at the end of 2016.