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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 August 25, 2014

Amgen issued results of a second phase III trial of AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD). The 26-week, randomized, double-blind, placebo-controlled trial gave subjects AMG 416 or placebo three times per week by intravenous injection with each hemodialysis treatment. Doses ranged from a minimum of 2.5mg to a maximum of 15mg. In the AMG 416 group, 74% of patients achieved a >30% reduction from baseline in PTH compared with 8.3% in the placebo arm, a statistically significant result. Secondary endpoints included the percent change from baseline during the EAP in serum phosphorus (P) concentration (mean changes of -7.71% and -1.31% among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -7.29% and 1.18% among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant. Treatment-emergent adverse events (TEAEs) were reported in 91.6% and 78.7% of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in >10% of patients who received AMG 416 included (AMG 416 v. placebo, respectively): blood calcium decreased (61% and 8.3%), nausea (12.4% and 5.1%), muscle spasms (12% and 7.1%) and vomiting (10.4% and 7.1%).

Austrianova released results of a phase II study of Cell-in-a-Box combined with ifosfamide for treatment of advanced, inoperable cancer. Thirteen patients with advanced, inoperable pancreatic cancer have been treated with the Cell-in-a-Box/ifosfamide combination in the uncontrolled (no comparator arms), open-label study. A single implantation of Cell-in-Box capsules (each capsule contained approximately 10,000 cells capable of converting the anticancer prodrug ifosfamide into its “cancer-killing” form by virtue of their overexpression of an isoform [CYP2B1] of human cytochrome P450) was used and two courses of treatment with ifosfamide were administered. There were no deleterious effects, such as inflammation or pancreatitis, that could be attributed to the Cell-in-a-Box capsules being implanted in the patients. The median survival of patients in the phase I/II clinical trial was about 40 weeks versus the 33 weeks seen in the phase II clinical trial. The percentage of patients who survived one year was somewhat lower in the phase II clinical trial (23%) than in the phase I/II clinical trial (38%). The dose (1g/ m2) of ifosfamide used in the phase I/II clinical trial was one-third of the “normal” dose of ifosfamide, whereas the dose used in the phase II clinical trial was twice (2g/m2) that dose. A phase IIb trial has been planned in Australia implementing the 1g/m2 dose of ifosfamide instead of the 2g/m2 dose.

MediciNova issued positive interim results of a phase IIa trial of MN-166 (ibudilast) in opioid dependence. The study is a randomized, placebo-controlled, double-blind, inpatient phase IIa study of MN-166 (ibudilast) in opioid-dependent abusers of prescription opioids and/or heroin. The study duration is approximately six weeks per subject. The crossover study design includes initial detoxification followed by randomization to ibudilast 50mg BID or placebo. Subjects are maintained on each dose for at least two to three consecutive weeks (one week stabilization + 1.5 week testing). During test weeks, participants receive oxycodone (zero mg, 15mg or 30mg PO) in random order on separate days. For each dose, a sample followed by a choice session is completed. During the choice session, a drug versus money self-administration paradigm is employed. MN-166 significantly decreased the craving for heroin (p<0.05), cocaine (p<0.05) and tobacco (p<0.05). MN-166 also decreased the positive subjective effects of oxycodone measured by mean responses to statements such as “I Feel High” (p<0.05) and “I Liked the Dose” (p<0.05). MN-166 also enhanced the analgesic effects of oxycodone. MN-166 reduced the sum score on the McGill Pain Questionnaire, reduced the mean rating on the Painful scale, and reduced the mean rating on the Bothersome scale (p<0.05). Finally, MN-166 decreased the reinforcing effects of oxycodone.

Sanofi Pasteur reported results from a large-scale, multi-center efficacy trial, which found that Fluzone High-Dose (Influenza Vaccine) was more efficacious in preventing influenza in adults 65 years of age and older compared to standard-dose Fluzone vaccine. Investigators compared the vaccine’s efficacy in a randomized, double-blind trial that spanned two influenza seasons. The trial enrolled nearly 32,000 participants; 14,500 and 17,489 adults 65 years of age and older during the 2011- 2012 and 2012-2013 influenza seasons, respectively, from 126 research centers in the U.S. and Canada. 228 people in the Fluzone High-Dose vaccine group (1.43%) and 301 people in the standard-dose Fluzone vaccine group (1.88%) had laboratory-confirmed influenza, demonstrating Fluzone High-Dose vaccine was 24.2% (95% CI, 9.7 to 36.5) more effective in preventing influenza than standard-dose Fluzone vaccine. Additionally, researchers determined most rates for pneumonia, cardio-respiratory conditions, hospitalizations, non-routine medical office visits and medication use were lower for the Fluzone High-Dose vaccine group compared to the standard-dose Fluzone vaccine group. These results formed the basis of an FDA regulatory submission late last year to seek a modification to the prescribing information for Fluzone High-Dose vaccine reflecting the improved efficacy compared to standarddose Fluzone vaccine in adults 65 years of age and older. Sanofi Pasteur anticipates a decision later this year.