8-K – Current report

On April 12, 2016 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Company" or "Adamis") reported that it has successfully completed its previously announced acquisition (the "Acquisition") of US Compounding, Inc. ("USC") (Filing, 8-K, Adamis Pharmaceuticals, APR 12, 2016, View Source [SID:1234510680]). Upon the closing of this transaction, USC has become a wholly-owned subsidiary of Adamis.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are pleased to have completed this transformational acquisition that will expand our product portfolio, provide immediate revenues, as well as significantly increase our manufacturing, sales and marketing capabilities. The combination will now position us to better commercialize our pipeline products upon approval and diversify our revenue mix.
Our Epinephrine Pre-filled Syringe ("PFS") has an FDA agency action date (PDUFA date) of June 4, 2016. The potential revenues from the PFS combined with the anticipated cash flows from USC, should put Adamis in a strong financial position."

Please see Adamis’ Form 8K filed with the Securities and Exchange Commission for additional details on the transaction.

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Prognostic significance of Wilms tumor 1 mRNA expression levels in peripheral blood and bone marrow in patients with myelodysplastic syndromes.

This present study was designed to follow up 82 patients among 115 MDS patients registered in study ODK-0801 for 5 years, to analyze the relationship between the WT1 mRNA expression level and prognosis.
This study aimed to investigate the clinical utility of WT1 mRNA expression levels.
After study ODK-0801, we investigated the conditions of the same patients once a year, including any clinical and laboratory findings supporting the diagnosis, and treatment among the living patients.
When we assessed the survival time of 82 MDS patients by WT1 mRNA expression level, there were significant differences between the < 500 and ≥ 104 copies/μ g RNA groups and between the 500-104 and ≥ 104 copies/μ g RNA groups for BM levels (p < 0.01). Examination of the time of freedom from cute myeloid leukemia (AML) transformation indicated that a high WT1 mRNA expression level (> 104 copies/μ g RNA) was a strong prognostic factor for a short time to AML transformation.
The results indicate that the tumorigenesis of MDS is likely to originate at the stem cell level, suggesting that the WT1 mRNA level measurement in the BM is an effective prognostic marker in patients with MDS.

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Complications of Cytoreductive Surgery and HIPEC in the Treatment of Peritoneal Metastases.

The combined treatment concept of cytoreductive surgery (CRS) and Hyperthermic intraperitoneal chemotherapy (HIPEC) has shown to be an efficient therapeutic option for selected patients with primary and secondary peritoneal carcinomatosis (PC). This strategy represents the standard of care for diseases like pseudomyxoma peritonei and peritoneal mesothelioma, and offers the best long-term results for PC from colorectal cancer. Despite these results, skepticism exists regarding this therapeutic approach partly because of its perceived high toxicity. In this article, we review the current evidence on complications that can occur after CRS and HIPEC and the risk factors associated with increased incidence of morbidity and mortality.

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Systematic review of efficacy of anti-tumor necrosis factor (TNF) therapy in patients with psoriasis previously treated with a different anti-TNF agent.

Tumor necrosis factor (TNF) antagonists have improved outcomes for patients with psoriasis, but some patients are unresponsive to treatment (primary failure) or lose an initially effective response (secondary failure).
We sought to systematically investigate the efficacy and safety of a second TNF antagonist after failure of a first TNF antagonist.
Published primary studies evaluating the efficacy of switching TNF antagonists after failure were systematically extracted.
Fifteen studies were included. Although response rates to a second TNF antagonist were lower than for a first, a substantial proportion of patients in every study achieved treatment success. Week-24 response rates for a second antagonist were 30% to 74% for a 75% improvement in Psoriasis Area and Severity Index score and 20% to 70% for achieving a Physician Global Assessment score of 0/1; mean improvements in Dermatology Life Quality Index ranged from -3.5 to -13. In general, patients who experienced secondary failure achieved better responses than patients with primary failure. Adverse event incidences ranged from 20% to 71%, without unexpected adverse events; 0% to 11% of patients experienced serious adverse events.
There was no common definition of treatment failure across these studies of varied design.
Some patients benefit from switching to a second TNF antagonist after failure of a first TNF antagonist, with improved quality of life.
Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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Influence of the HER2 Ile655Val polymorphism on trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients: a meta-analysis.

The HER2 655 A>G genetic variant has recently been associated with trastuzumab-induced cardiotoxicity in HER2 breast cancer patients. Considering previous results, the aim of our study was to validate the role of this polymorphism as a predictor of the cardiac toxicity of trastuzumab in breast cancer patients.
Our study population was composed of 78 HER2 breast cancer patients receiving trastuzumab. The HER2 655 A>G (rs1136201) genetic variant was genotyped using TaqMan allelic discrimination technology. Patients were classified on the basis of the occurrence of cardiotoxic events or the absence of cardiotoxic events during 1 year after the first infusion.
The HER2 655 A>G polymorphism was significantly associated with cardiotoxicity: AG versus AA [P=0.012, odds ratio (OR)=5.12, 95% confidence interval (CI) 1.43-18.36], AG+GG versus AA (P=0.01, OR=5.72, 95% CI 1.50-21.76), AG versus AA+GG (P=0.005, OR=7.17, 95% CI 1.82-28.29). A meta-analysis combining these data with the results from previous studies confirmed this association.
Our results support the role of the HER2 655 A>G polymorphism as a genetic marker of trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients.

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