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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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Heat Biologics to Present at the American Association for Cancer Research (AACR) Annual Meeting

On April 12, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported three poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting, including initial preclinical results from Heat’s collaboration with OncoSec Medical Incorporated, a biotechnology company developing DNA-based intra-tumoral cancer immunotherapies (Press release, Heat Biologics, APR 12, 2016, View Source [SID:1234510679]). The AACR (Free AACR Whitepaper) Annual Meeting is being held on April 16-20, 2016 in New Orleans, LA.

The details for the poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting are as follows:

Title: In vivo intra-tumoral electroporation of Gp96-Ig/Fc-OX40L stimulates CD8+ T cell cross-priming to tumor specific neoantigens
Date and Time: April 17, 2016 at 1:00 p.m. – 5:00 p.m. CT
Location: Section 26
Session Title: Immune Modulating Agents 1
Abstract ID: 567

Title: Vesigenurtacel-L stimulates tumor infiltration of unique polyclonal T cell clones in non-muscle invasive bladder cancer patients
Date and Time: April 18, 2016 at 8:00 a.m. – 12:00 p.m. CT
Location: Section 22
Session Title: Immune Response Monitoring: Clinical
Abstract ID: 1405

Title: Combination immunotherapy: T cell costimulation (OX40L, TL1A, 4-1BBL and ICOSL) secreted locally by Gp96-Ig vaccines, elicits robust antigen-specific, memory T cell responses and tumor elimination
Date and Time: April 18, 2016 at 1:00 – 5:00 p.m. CT
Location: Section 27
Session Title: Therapeutic Antibodies and Vaccines
Abstract ID: 2353

Copies of the abstracts are available and can be viewed online through the AACR (Free AACR Whitepaper) website at www.aacr.org. Posters will be uploaded to the Publications section of Heat’s corporate website upon completion of the sessions to abide by the conference’s embargo policy.

Efficacy and safety of mitotane in the treatment of adrenocortical carcinoma: A retrospective study in 34 Belgian patients.

Evaluation of patient characteristics and mitotane use in the treatment of adrenocortical carcinoma (ACC) over a 4-year period in Belgium.
This was a multicentre retrospective review of the outcome of 34 patients treated with mitotane for ACC during the period [01/2008-12/2011] (12 diagnosed before and 22 diagnosed during the study period) and evaluated up to 06/2013.
Patient and tumour characteristics were consistent with those generally described for ACC. Mean age at diagnosis was 46.5 years, most patients were female (62%), had functioning ACC (65%) and advanced tumours (ENSAT stages III or IV: 82%). Therapeutic mitotane plasma levels (14-20 mg/L) were achieved at least once in 70% of the cohort, after a median of 4 months, and were maintained for more than 2 months in 61% of evaluable patients. Mitotane-related adverse effects were observed in 66% of patients, were never serious, and included gastrointestinal, neurological, neuropsychological, hormonal, dermatologic and metabolic effects. Most patients (88%) discontinued mitotane, mainly due to tumour progression. Multivariate analysis showed that ENSAT stage was a prognostic factor for overall (OS) and disease-free survival (DFS); OS was also influenced independently by achievement of therapeutic mitotane plasma levels for at least two consecutive months.
Patient and tumour characteristics were consistent with previously published data. OS and DFS were mostly influenced by ENSAT stage at diagnosis. Achieving therapeutic levels of mitotane for at least two consecutive months seemed to positively influence OS, but such levels were not reached or sustained in some patients.
Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with Clostridium difficile infection (CDI) in Germany.

Clostridium difficile infection (CDI) represents a significant economic healthcare burden, especially the cost of recurrent disease. Fidaxomicin produced significantly lower recurrence rates and higher sustained cure rates in clinical trials. We evaluated the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the first-line treatment of patient subgroups with CDI at increased risk of recurrence.
A semi-Markov model was used to compare the cost-effectiveness and budget impact of fidaxomicin vs. vancomycin from a payer perspective in Germany. The model cycle length was 10 days. The time horizon was 1 year. Model inputs were probability of clinical cure, 30-day probability of recurrence, and 30-day attributable mortality based on evidence from two randomized controlled trials comparing fidaxomicin and vancomycin in patients with CDI. Cost-effectiveness outcomes were cost per quality-adjusted life year gained, cost per bed-day saved, and cost per recurrence avoided.
Despite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup (less costly and more effective) and cost-effective in the other subgroups, with incremental cost-effectiveness ratios vs. vancomycin ranging from €26,900 to €44,500. Hospitalization costs of the first-line treatment of CDI with fidaxomicin vs. vancomycin were lower in every patient subgroup, resulting in budget impacts ranging from -€1325 (in patients ≥65 years) to -€2438 (in cancer patients). Reductions in the cost of treating recurrence with fidaxomicin ranged from -€574.32 per patient in those receiving concomitant antibiotics to -€1500.68 per patient in renally impaired patients.
In patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer.

Analysis of 589,306 genomes identifies individuals resilient to severe Mendelian childhood diseases.

Genetic studies of human disease have traditionally focused on the detection of disease-causing mutations in afflicted individuals. Here we describe a complementary approach that seeks to identify healthy individuals resilient to highly penetrant forms of genetic childhood disorders. A comprehensive screen of 874 genes in 589,306 genomes led to the identification of 13 adults harboring mutations for 8 severe Mendelian conditions, with no reported clinical manifestation of the indicated disease. Our findings demonstrate the promise of broadening genetic studies to systematically search for well individuals who are buffering the effects of rare, highly penetrant, deleterious mutations. They also indicate that incomplete penetrance for Mendelian diseases is likely more common than previously believed. The identification of resilient individuals may provide a first step toward uncovering protective genetic variants that could help elucidate the mechanisms of Mendelian diseases and new therapeutic strategies.