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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 March 2, 2015

AbbVie issued results of the phase II portion of its phase II/III open-label study of VIEKIRA PAK and ribavirin (RBV) in genotype 1 chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection. The study is an ongoing, multi-center, randomized, open-label study evaluating the efficacy and safety of VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir (25/150/100mg once daily) and dasabuvir (250mg twice daily) with RBV (weight based dosing of 1000mg or 1200mg per day divided twice daily) for 12 or 24 weeks in adult patients with chronic GT1 HCV infection with or without compensated liver cirrhosis who also are infected with HIV-1. The study showed patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1 receiving VIEKIRA PAK and ribavirin (RBV) for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 94% (n=29/31) and 91% (n=29/32), respectively. The SVR12 rates were 91% (n=51/56) for subjects with HCV GT1a infection and 100% (n=7/7) for those with HCV GT1b infection. The most common adverse events occurring in at least 10% of patients in TURQUOISE-I were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), itching (13%), cough (11%), irritability (10%) and yellowing of the eyes (10%).

Boehringer Ingelheim released results of five phase III trials of tiotropium delivered via Respimat inhaler for treatment of mild, moderate and severe asthma in subjects who continue to experience symptoms despite the use of maintenance therapies. The studies included in these analyses were double-blind, placebo-controlled, parallel-group trials in adult patients. A total of 3,480 patients were randomized for the five trials to receive tiotropium 5mcg, 2.5mcg or placebo in addition to including inhaled corticosteroids with or without long-acting beta agonists. Three criteria were used to determine whether or not a patient had allergies: total serum immunoglobulin E (IgE, < or =430mcg/L [equivalent to 179.2 IU/L]), blood eosinophils (< or =0.6×109/L) or investigator judgment (No/Yes). Patients were permitted to receive additional background therapy, which varied from trial to trial, and included treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab. The adverse event (AE) data presented is pooled from the five phase III trials in adults. The most commonly reported AEs, by preferred term, from the pooled analyses were asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis and upper respiratory tract infection.

Immunomedics reported results of a study of sacituzumab govitecan for treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). A total of 44 heavily-pretreated patients with relapsed or refractory lung cancer have been enrolled into this multicenter study. At the time of analysis, 16 patients with SCLC and 18 with NSCLC were evaluated by computed tomography for response and time-to-progression (TTP). Despite the late-stage setting, TTP for most patients was longer with sacituzumab govitecan than the duration of their previous lung cancer therapy. 33% of patients with SCLC and 31% with NSCLC had their tumor reduced in size by 30% or more. Sacituzumab govitecan controlled the progression of the cancer in 75% and 56% of NSCLC and SCLC patients, respectively. These patients had either failed to respond to their last lung cancer therapies or their cancer had returned or progressed. Sacituzumab govitecan continues to produce an acceptable safety profile in heavily-pretreated patients, with neutropenia (24% grades three and four combined) as the major toxicity. Diarrhea, the typical side effect of irinotecan treatment, was minimal at 3% grade three. More importantly, repeated efficacious doses of the ADC can be given to patients over months without evoking any interfering immune response.

Pharmacyclics reported results of the phase I portion of a phase I/IIb study of IMBRUVICA (ibrutinib). Treatment with IMBRUVICA was associated with an 88% overall response rate (ORR), with a median time on study of 23.3 months, in 16 patients with relapsed/refractory (R/R) high-risk chronic lymphocytic leukemia (CLL). These patients had a median of five prior therapies and 63% were high-risk del 17p CLL patients. The estimated median progression-free survival (PFS) at 24 months was 76.6%. All patients had previously undergone allogeneic stem cell transplant. Pharmacyclics now is enrolling the phase II portion at the recommended phase II dose of 420mg.

Sangamo BioSciences issued results of a phase I/II trial of SB-728-T for HIV/AIDS. HIV-infected subjects were enrolled in six cohorts. The study evaluated the effect of increasing doses of Cytoxan preconditioning as a method to maximize engraftment of ZFN- modified cells (SB- 728-T). Cohorts 1-5 (18 subjects) were designed primarily to evaluate the safety and tolerability of escalating doses of cyclophosphamide (Cytoxan) (doses tested: 200mg, 500mg/m, 1g/m, 1.5g/m or 2g/m) administered prior to an infusion of SB-728-T (CD4 cell enriched). The sixth cohort, Cohort 3 (three subjects) was designed to evaluate a CD4/CD8 SB-728-T product post-administration of Cytoxan at the optimal dose of 1g/m. Cytoxan preconditioning at doses up to 1gm/m safely enhanced total CD4 and CCR5 modified CD4 T-cells (Cohorts 1-5). Data from Cohorts 1-5 demonstrated a dose-related increase in both total CD4 T-cell and ZFN modified CD4 T-cell engraftment in response to Cytoxan preconditioning up to 1g/m. In addition, all subjects underwent a treatment interruption (TI) and were taken off antiretroviral drugs (ART) at 16 weeks post infusion. Four subjects from Cohort 1-5 remain on long-term TI and have remained off ART for at least 40 weeks.

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