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Antoniades, C. et al. Association of plasma asymmetrical dimethylarginine (ADMA) with elevated vascular superoxide production and endothelial nitric oxide synthase uncoupling: implications for endothelial function in human atherosclerosis. European heart journal 30, 1142-1150 , doi: 10.1093/eurheartj/ehp061 (2009).

Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, patient willingness to undergo a liver biopsy in our NASH trials, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and disadvantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating. Potential patients for Aramchol may not be adequately diagnosed or identified with the diseases which we are targeting or may not meet the entry criteria for our studies.

Although most jurisdictions in which the Company has applied for, intends to apply for, or has been issued patents have patent protection laws similar to those of the United States, some of them do not. For example, the Company expects to do business in South America, Eurasia, China and Indochina in the future and the countries in these regions may not provide the same or similar protection as that provided in the United States.

        Cash flows used in operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for (1) non-cash operating items such as depreciation and amortization, stock-based compensation and changes in fair value of preferred stock tranche rights as well as (2) changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in our results of operations.

“For another thing, Liz knew that our biotech firm, Telocyte, intends to do almost the same thing, but with a few crucial differences: we will only be using telomerase (hTERT) and we intend to pursue human trials that have FDA clearance, have full IRB agreement, and meet GMP (“Good Medical Production”) standards.”

        In March 2019, we announced pre-clinical data for the extended release, or XR, formulation of zilucoplan, in which a single subcutaneous dose achieved greater than one week of target drug concentrations in non-human primates, supporting once weekly or less frequent dosing. We anticipate the XR program entering human clinical studies in the first half of 2020.

On combining epigenetic reprogramming and senolytics, this paper would suggest this might be unnecessary: ‘Rejuvenating senescent and centenarian human cells by reprogramming through the pluripotent state’, PMC3219229.

Cynapsus Therapeutics Inc.  (OTC:CYNAF, TSX:CTH.V) is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "OFF" motor symptoms of Parkinson’s disease. Cynapsus’ drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from "OFF" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application ("NDA") expected to be submitted in 2016. Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson’s disease. Parkinson’s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Company’s Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience "OFF" episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease’s symptoms, and most drugs become less effective over time as the disease progresses.

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Akela Pharma Inc (TSX:AKL.TO) is a drug development company with its lead product, Fentanyl TAIFUN®, being developed for the treatment of breakthrough cancer pain. Fentanyl TAIFUN® is a fast-acting fentanyl formulation delivered using the company’s TAIFUN® multi-dose dry powder inhaler platform. Akela’s pipeline also includes a growth hormone releasing hormone (GHRH), which is being developed for frailty and wasting in chronic renal disease. PharmaForm, Akela’s wholly owned subsidiary, is a leading specialty contract service provider in the area of hot melt extrusion, and also offers a portfolio of other innovative technologies in drug product development, manufacturing and analytical testing to the pharmaceutical and biotechnology industries. Through its diverse offerings, PharmaForm solutions help clients reach their development targets, reduce development costs and accelerate time-to-market.

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