On April 21, 2016 Camurus (NASDAQ STO: CAMX) reported that they have granted R-PHARM US (Princeton, NJ) the exclusive license and distribution rights for episil oral liquid in the US (Press release, Camurus, APR 21, 2016, View Source [SID:1234511235]).

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episil oral liquid, is a unique and effective treatment for the pain of oral mucositis, a treatment-limiting side effect of cancer therapies, as well as other oral lesions. Financial terms under this agreement are not disclosed.

About oral mucositis
Oral mucositis (OM) is a common side effect of cancer therapies (chemo- and radiotherapy) and is characterized by painful inflammation and ulceration of the oral mucosa. OM affects nearly all head and neck cancer patients receiving radiotherapy (RT), 30%-75% of patients undergoing chemotherapy and most patients undergoing conditioning regimens for hematopoietic stem cell transplant.

OM is caused by damage to the DNA in the basal epithelial cell lining of the mouth leading to decreased cell proliferation and cell death. Symptoms of OM vary from pain and discomfort to an inability to tolerate food or fluids, which can prevent patients from eating, swallowing and speaking. OM often necessitates hospitalization for re-hydration, opiate pain medication and total parenteral nutrition. Patients with damaged oral mucosa and reduced immunity resulting from chemo- and radiotherapy are also prone to infections in the mouth. Severe OM can even limit the dosing and frequency of treatment for cancer.

About episil oral liquid
episil oral liquid represents a unique and innovative concept for local treatment of pain associated with OM. Developed using the award-winning* Camurus proprietary technology FluidCrystal, episil is administered as a lipid-based liquid that spreads on the intra-oral mucosal surfaces and transforms to a strongly bioadhesive film that mechanically protects the sensitized and sore epithelium of the oral cavity. Clinically demonstrated, episil has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. episil oral liquid is supplied as a ready-to-use, pocket-sized device helping patients maintain their quality of life while undergoing cancer therapy. episil was first launched in Europe and is today commercially available in a number of countries. episil oral liquid is a CE-marked medical device class 1 in Europe and a 510k registered medical device in the US.

Sonidegib selectively inhibits smoothened protein, suppresses the growth of Hedgehog pathway-dependent tumors, and has recently been approved in the indication of locally advanced basal cell carcinoma. A comprehensive exposure-response analysis was conducted to further characterize the relationship of sonidegib exposure to efficacy and safety. Minimum observed plasma concentration at pre-dose (Cmin), peak concentration (Cmax), and area under the curve were used as exposure endpoints. Exposure-efficacy analyses included data from 190 patients who received sonidegib 200 mg or 800 mg once daily in the primary efficacy study. Objective response rate (ORR) (complete response [CR] or partial response [PR]), progression-free survival (PFS), and time to tumor response (TTR) were assessed by logistic regression, Cox regression and Kaplan-Meier analyses. Exposure-safety (creatine phosphokinase [CK] elevation) analyses included data from 336 patients pooled from four clinical trials and included doses across ranges of 100-3000 mg once daily and 250-750 mg twice daily. Similar plasma exposure was observed between responders and non-responders. The logistic regression model of Week 5 Cmin vs. ORR indicated no relationship between sonidegib exposure resulting from 200 mg or 800 mg doses and the probability of CR or PR. A similar conclusion of no exposure-efficacy relationship was drawn from the PFS and TTR analyses. Increased exposure was associated with a greater risk of Grade 3 or 4 CK elevation, with lower risk in females than in males when using Cmin in the model. These analyses support the sonidegib dose recommendation for registration and are consistent with clinical observations. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.

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AMG 820 is a human monoclonal antibody that inhibits c-fms and decreases tumor-associated macrophage (TAM) function. It is being investigated as a treatment for various cancer types (Company Pipeline, Amgen, APR 21, 2016, View Source [SID:1234511229]).

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Large-scale multiplexed identification of somatic alterations in cancer has become feasible with next generation sequencing (NGS). However, calibration of NGS somatic analysis tools has been hampered by a lack of tumor/normal reference standards. We thus performed paired PCR-free whole genome sequencing of a matched metastatic melanoma cell line (COLO829) and normal across three lineages and across separate institutions, with independent library preparations, sequencing, and analysis. We generated mean mapped coverages of 99X for COLO829 and 103X for the paired normal across three institutions. Results were combined with previously generated data allowing for comparison to a fourth lineage on earlier NGS technology. Aggregate variant detection led to the identification of consensus variants, including key events that represent hallmark mutation types including amplified BRAF V600E, a CDK2NA small deletion, a 12 kb PTEN deletion, and a dinucleotide TERT promoter substitution. Overall, common events include >35,000 point mutations, 446 small insertion/deletions, and >6,000 genes affected by copy number changes. We present this reference to the community as an initial standard for enabling quantitative evaluation of somatic mutation pipelines across institutions.

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Mitochondrial dysfunction is a hallmark of aging, and underlies the development of many diseases. Cells maintain mitochondrial homeostasis through a number of pathways that remodel the mitochondrial proteome or alter mitochondrial content during times of stress or metabolic adaptation. Here, using yeast as a model system, we identify a new mitochondrial degradation system that remodels the mitochondrial proteome of aged cells. Unlike many common mitochondrial degradation pathways, this system selectively removes a subset of membrane proteins from the mitochondrial inner and outer membranes, while leaving the remainder of the organelle intact. Selective removal of preexisting proteins is achieved by sorting into a mitochondrial-derived compartment, or MDC, followed by release through mitochondrial fission and elimination by autophagy. Formation of MDCs requires the import receptors Tom70/71, and failure to form these structures exacerbates preexisting mitochondrial dysfunction, suggesting that the MDC pathway provides protection to mitochondria in times of stress.

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