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Can-Fite gives replace on Part II scientific trial with drug candidate Namodenoson


Can-Fite BioPharma Ltd., a biotechnology firm advancing a pipeline of proprietary small molecule medicine that deal with most cancers, liver and inflammatory illnesses, at this time offered an replace on its Part II scientific trial with drug candidate Namodenoson (CF102) within the therapy of superior hepatocellular carcinoma (HCC) in sufferers whose illness has progressed on sorafenib remedy. Can-Fite anticipates analyzing the outcomes of this necessary trial earlier than the top of the present 12 months.

The worldwide Part II examine is being carried out within the U.S., Europe and Israel. Sufferers with superior HCC, Little one Pugh B, who failed Nexavar (sorafenib) as a primary line therapy are handled twice each day with 25 mg of oral Namodenoson or placebo utilizing a 2:1 randomization. The first endpoint of the Part II examine is Total Survival (OS). Secondary endpoints embody Development Free Survival (PFS), security, and the connection between outcomes and A3AR expression.

The trial first opened to enrollment in December 2014 and enrollment of 78 sufferers was accomplished in August 2017. Whereas the trial continues treating topics in a blinded vogue (both Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 topics initially enrolled, 19 accomplished at the very least 12 cycles of therapy (every cycle is 28 days of therapy) of which three accomplished at the very least 24 cycles. The longest-treated topic has been receiving examine medicine for roughly three years.

Amassed security knowledge up to now continues to point a positive security profile, with no clinically important novel or rising occasions attributed to power therapy with Namodenoson.

Michael Silverman, MD, FACP, Can-Fite’s Medical Director says, “Whereas the ultimate evaluation of this trial, based mostly on survival, has been delayed previous our unique projections, we’re very completely happy that the explanation for that is the sudden longevity of sufferers enrolled into this trial. Traditionally, HCC sufferers who’ve failed therapy with sorafenib and are Little one Pugh B, have very restricted life expectancy. Though the trial knowledge are nonetheless blinded, we’re inspired by the unexpectedly lengthy survival for some sufferers and hope that this can translate right into a survival benefit for the Namodenoson group over the placebo group, and a vital advance for treating sufferers with HCC.”

Can-Fite acquired Orphan Drug Designation for Namodenoson in Europe and the U.S., in addition to Quick Monitor Standing within the U.S. as a second line therapy for HCC.



Posted in: Drug Trial Information | Medical Situation Information

Tags: Adenosine, Arthritis, Biotechnology, Most cancers, Carcinoma, Scientific Trial, Medicine, Fatty Liver, Hepatocellular Carcinoma, Inflammatory Illness, Life Expectancy, Liver, Liver Most cancers, Liver Illness, Melanoma, Molecule, Nexavar, Placebo, Preclinical, Prostate, Psoriasis, Receptor, Rheumatoid Arthritis, Sexual Dysfunction, Sorafenib

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