Clinical Trial Resource Center

Clinical Trial Resource Center

New Medical Therapies™

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 July 21, 2014

Agenus issued results of a phase II study of HerpV for treatment of genital Herpes Simplex Virus-2 (HSV-2). The randomized, double-blind, multi-center study enrolled 80 subjects with a history of one to nine herpes recurrences within the prior 12 months. 70 subjects received the active treatment, HerpV and QS-21 Stimulon, and 10 subjects received placebo. Three injections of HerpV at a dose of 240μg (includes12μg of a mix of 32 different HSV-2 antigenic peptides) or placebo were given at two week intervals. HSV-2 activity in the genito-urinary tract was monitored by PCR for HSV-2 DNA in genital swabs for 45 days before and after the initial course of three vaccinations. The primary analysis, which looked at viral shedding after the initial three HerpV vaccinations, demonstrated that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). The results also demonstrate a reduction in viral load of 34% (P=0.08). Placebo patients showed no reduction compared to baseline in either parameter. More than half of those vaccinated developed a robust anti-HSV cytotoxic T-cell immune response, and in those patients there was a statistically significant 75% reduction in viral load (P<0.001; CI: 46.2—88.6%). After the booster shot, HerpV demonstrated a durable reduction in viral shedding approximating 14% (RR=0.86 and CIs: 0.58-1.26) and remains consistent with the reduction in viral shedding observed duing the initial treatment period.

Boehringer Ingelheim released results of a phase II trial of volasertib for older patients with acute myeloid leukemia (AML). The open- label study enrolled 87 adult patients (median age 75) with AML not considered suitable for intensive induction therapy. Patients were randomly assigned to receive either volasertib in combination with LDAC (n=42) or LDAC (n=45). Patients were randomized in a 1:1 ratio to receive the combination of LDAC plus volasertib 350mg intravenously over one hour on days one and 15 versus LDAC 20mg twice daily subcutaneously on days one to 10 alone. Cycles were scheduled every four weeks until progression, relapse, intolerance or patient/ investigator requested discontinuation. The study’s primary endpoint showed the objective response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for patients receiving volasertib and LDAC versus LDAC alone (31% v. 13.3%, p=0.052). The trial showed patients treated with volasertib combined with LDAC had a median overall survival of eight months versus 5.2 months in patients treated with LDAC (p=0.047). Median event-free survival was prolonged in patients receiving volasertib and LDAC versus LDAC (5.6 months v. 2.3 months; p=0.021). Relapse- free survival for volasertib and LDAC versus LDAC was 18.5 months versus 10 months. There is an ongoing phase III study initiated for volasertib.

Regeneron Pharmaceuticals and Sanofi reported results of a phase IIb trial of dupilumab in adult patients with moderate-to-severe atopic dermatitis (AD). This double-blind, placebo-controlled, 16-week, dose-ranging study enrolled 380 patients. Patients were randomized to receive one of five doses of dupilumab (300mg weekly, 300mg every other week, 300mg monthly, 200mg every other week, 100mg monthly) or placebo. The follow-up period of the study is ongoing and patients will be followed for 16 weeks after treatment. The improvements in Eczema Area and Severity Index (EASI) score ranged from a high of 74% for patients in the highest dose group, who received 300mg weekly, to a low of 45% in patients who received the lowest dose of 100mg monthly, compared to 18% for patients in the placebo group (p<0.0001 for all doses). 12% to 33% of dupilumab- treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator’s global assessment (IGA) score of 0 or 1, compared to 2% with placebo (p=0.02 to p<0.0001). Dupilumab-treated patients experienced a 16.5% to 47% mean reduction in itching, as measured by the pruritus numerical- rating scale (NRS) score, compared to an increase of 5% in the placebo group (p=0.0005 to p<0.0001).