Brief Report for Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM)
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS and, in turn, is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
In the first quarter of 2016, Peregrine plans to initiate two new Phase II clinical trials in breast and lung cancer in combination with current standard of care treatments including both chemotherapy and immuno-oncology agents. In addition, the company has entered into collaboration with the National Comprehensive Cancer Network (NCCN) to evaluate bavituximab in other tumor types and combinations. Additionally, the company is nearing completion of enrollment of an ongoing Phase III trial in non-small cell lung cancer (NSCLC) named SUNRISE.
Update for Bavituximab clinicals:
— Phase II Study in NSCLC in Collaboration with AstraZeneca Evaluating Bavituximab Plus Durvalumab to Expand Lung Cancer Program in Q1 2016
— Phase II/III Study in HER2-Negative Metastatic Breast Cancer is Now Underway with a Second Phase II Study in Early Stage Triple Negative Breast Cancer to Begin in Q1 2016
— Additional Studies to Broaden Evaluation of Bavituximab Immunotherapy and Standard of Care Combinations in Multiple Solid Tumors Planned for 2016
Brief Report for Amarin Corp. Plc (NASDAQ: AMRN)
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA.
Additional 2015 Operational Progress REDUCE-IT: Enrollment reached approximately 7,900 patients as of December 31, 2015, representing 99% of the patients targeted for enrollment in this prospective cardiovascular outcomes study, the first such study ever conducted to evaluate the effect of treating patients who despite statin therapy have elevated triglyceride levels and the first cardiovascular outcomes study to test a high, 4-gram per day dose of a pure-EPA omega-3 prescription product.
VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
2015 Net Product Revenue Estimated to Be Approximately $26.0 Million for the Fourth Quarter and $80 Million for the Full Year, Exceeding Prior Guidance; Anticipate Full-Year 2016 Net Product Revenues Between $105 Million and $120 Million, Commercial Operations Positioned to Be Cash Flow Positive Entering 2017
Brief Report for Anavex Life Sciences Corp. (NASDAQ: AVXL)
The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others.
Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The company recently reported a positive dose-response relationship has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer’s disease. The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.
The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects; with no adverse events reported above grade one.
Brief Report for Sunshine Biopharma Inc. (OTCQB: SBFM)
Adva-27a is Sunshine Biopharma’s lead anticancer compound, a Topoisomerase II inhibitor, small molecule that has recently been shown to be effective at killing Multidrug Resistant Breast Cancer cells, Pancreatic Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Sunshine Biopharma is direct owner of all issued and pending worldwide patents pertaining to Adva-27a including U.S. Patent Number 8,236,935. Adva-27a is currently in the IND-Enabling stage of development. The Company is planning Phase I clinical trials of Adva-27a for Pancreatic Cancer and in parallel Multidrug Resistant Breast Cancer to be conducted at McGill University’s Jewish General Hospital in Montreal (Canada).
Adva-27a has proven to be effective at killing Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells and Uterine Sarcoma cells (Results published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). The Company is planning Phase I clinical trials of Adva-27a on Pancreatic Cancer and, in parallel, Multidrug Resistant Breast Cancer patient volunteers to be conducted at McGill University’s Jewish General Hospital in Montreal (Canada).
In December the company announced it had acquired all of the remaining rights, title and interest in and to all worldwide patents for the Company’s Adva-27a anticancer compound. The Patent Purchase Agreement executed today provides Sunshine with direct ownership of all issued and pending Adva-27a related patents, which include all rights to this intellectual property worldwide. Prior, Sunshine had ownership of only the U.S. patent. The purchase price paid by Sunshine for these patent rights was $12,822,499, which will be paid pursuant to the terms of a secured promissory note, with quarterly payments of principal and interest due through December 2020.
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