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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 January 26, 2015

Alkermes reported results of a phase III study of ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). The randomized, double-blind, parallel-arm, FORWARD-1 study evaluated the safety, tolerability and efficacy of two titration schedules of ALKS 5461 administered once daily as adjunctive treatment in 66 patients with MDD who had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Patients were assigned to either a one-week or two-week titration schedule of oral ALKS 5461, for a total treatment period of eight weeks. ALKS 5461 was generally well-tolerated in both of the two titration schedules evaluated. The exploratory efficacy analyses showed ALKS 5461 significantly reduced depressive symptoms from baseline starting at week one and continued to the end of the treatment period at week eight in patients who received either of the two titration schedules. The observed changes from baseline were clinically meaningful and statistically significant (p<0.001). These data support the one-week titration schedule being utilized in the core phase III efficacy studies in the FORWARD program.

Mesoblast has issued positive results of a phase II program of MPC-06-ID for the treatment of chronic low back pain due to degenerative disc disease. In the randomized, placebo-controlled trial of 100 patients, a single injection of Mesoblast’s allogeneic investigational mesenchymal precursor cell (MPC) product, MPC-06-ID, was welltolerated. A single injection of 6 million MPCs induced substantial and sustained pain relief over 24 months. At 12 and 24 months, 46% and 48% of MPC-06-ID-treated patients achieved minimal or no residual pain (VAS less than or equal to 20) compared with 13% and 13% of saline treated patients, p=0.042 and 0.093, respectively. In patients who received a single injection of six or 18 million MPCs, 44% and 42%, respectively, achieved the target composite endpoint of treatment success at both six and 12 months (50% reduction in pain, 15-point improvement in function and no further treatment intervention), compared with 13% of saline controls (p=0.006 and p=020). In patients who received six million MPCs and achieved the target composite endpoint of treatment success at both six and 12 months, 86% (11 of 13) maintained treatment success at 24 months (32% v. 11% saline controls, p=0.001). The phase III program for this indication has been initiated.

PharmaEngine released results of a phase III study of MM-398 (PEP02, liposome irinotecan injection) for metastatic pancreatic cancer. The global, randomized, openlabel study evaluated two MM-398 regimens, 80mg/m2 combined with 5-fluorouracil (5- FU) and leucovorin (LV) every two weeks, and 120mg/m2 as a monotherapy every three weeks. Each arm was compared to a control arm of 5-FU and LV. A total of 417 patients were randomized across the three arms. Each MM-398 regimen was compared against the control arm on the primary endpoint of overall survival. Patients were enrolled at 76 sites of the 105 sites initiated in North America, South America, Europe, Asia and Australia. The primary analysis demonstrated a statistically significant increase in overall survival with an unstratified hazard ratio of 0.67 (95% CI [0.49-0.92], p=0.0122) and a median of 6.1 months for the combination of MM-398 plus 5-FU/LV compared to 4.2 months in the 5-FU/LV control arm. In the stratified analysis, which accounts for pre-specified prognostic factors included in the study randomization stratification, the overall survival for MM-398 in combination with 5-FU/LV compared to control arm resulted in a hazard ratio of 0.57 (95% CI [0.41-0.80], p=0.0009). In the Per Protocol population (defined by patients who received 80% of protocol defined dose and were able to remain on treatment for at least six weeks), MM-398 in combination with 5-FU/LV demonstrated superior overall survival and tumor control to the control arm of 5-FU/LV alone. In the Per Protocol analysis, median overall survival for the combination therapy arm was 8.9 months versus 5.1 months in the control arm (stratified HR = 0.47, 95% CI [0.29-0.77], p=0.0018).

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