New Medical Therapies™
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.
Agenus released preliminary results from a phase II trial of Prophage G-100 (HSPPC-96) for glioblastoma multiforme (GBM). This single-arm study enrolled 46 patients with newly diagnosed GBM. Subjects received the HSPPC-96 vaccination, as well as radiation and temozolomide as the standard of care. Results showed patients treated with the HSPPC-96 arm showed a 146% increase in progression-free survival (PFS) over standard of care alone (17 months versus 6.9 months, respectively) and a 60% increase in overall survival (OS) over standard of care alone (23.3 months versus 14.6 months, respectively). In addition, 32 patients treated at UCSF underwent testing for expression of B7-H1 in blood samples taken prior to surgery, which showed patients with low expression of B7-H1 (53%) had better PFS (21.6 months) than those with high B7-H1 (47%) expression (11.4 months). This finding may have the potential to help identify a more responsive patient population for future trials.
Amgen issued results from a phase III head-to-head trial of Vectibix (panitumumab) versus Erbitux (cetuximab) for chemorefractory metastatic colorectal cancer (mCRC). This global, randomized, parallel-assignment, open-label, non-inferiority study enrolled 1,010 patients with mCRC with wild-type KRAS tumors. Subjects received 6mg/kg of intravenous Vectibix every 14 days or 400mg/m2 of an initial dose of intravenous Erbitux followed by 250mg/m2 of intravenous Erbitux every seven days. Data demonstrated the estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95% CI: 0.839, 1.113) favoring the Vectibix arm. Vectibix was well tolerated. Overall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia.
Celgene International reported results from a phase III trial of apremilast for the treatment of psoriatic arthritis. This multi-center, double-blind, placebo-controlled, parallel-group study enrolled over 500 patients with psoriatic arthritis. Subjects received apremilast 20mg or 30mg twice daily, or placebo, for 24 weeks, with a subsequent extension in which all patients are treated with apremilast. Data demonstrated statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20mg and 30mg. Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints: various measures of physical function and signs and symptoms. The drug was well tolerated. The most frequent adverse events were nausea, diarrhea and headache. Based on this data, Celgene expects to file a separate NDA in the U.S. for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
Esperion Therapeutics reported results from a phase II trial of ETC-1002 for type 2 diabetes and hypercholesterolemia. This randomized, double-blind, placebo-controlled, parallel-group study enrolled 60 patients with type 2 diabetes (HbA1C 7-10%), a body mass index of 25-35kg/m2, and LDL-C≥100mg/dL. Subjects received ETC-1002 80mg for two weeks followed by ETC-1002 120mg for two weeks, or placebo for four weeks, and were treated in an inpatient unit where their diet and lifestyle were controlled. Results showed after two weeks of treatment with 80mg of ETC-1002, LDL-C was reduced by an average of 32% (p<0.0001), while after an additional two weeks of 120mg of ETC-1002, LDL-C was reduced by an average of 43% (p<0.0001) compared with 6% and 3% reductions, respectively, for those patients treated with placebo. ETC-1002 also significantly reduced non-HDL-C (by 30%; p=0.0001) and high sensitivity C-reactive protein (hsCRP) and blood pressure compared with placebo. ETC-1002 had neutral effects on other lipids, including triglycerides and HDL-C. The drug was well tolerated. The most frequent adverse events were headache, hyperglycemia, constipation, arthralgia, dry eye and viral upper respiratory tract infection. Esperion is currently evaluating ETC-1002 in multiple phase II trials in more targeted patient populations.
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