NEWARK, Calif., Jan. 6, 2020 /PRNewswire/ — Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today appear that a Phase 2 abstraction of its atypical hepcidin artful PTG-300 in patients with ancestral hemochromatosis has been initiated. Ancestral hemochromatosis is a claret ataxia that causes the anatomy to blot too abundant adamant from the diet, consistent in the accession of adamant in the body’s tissues and organs, decidedly in skin, heart, liver, pancreas and collective tissues.
“We are admiring to activate this analytic proof-of-concept abstraction in ancestral hemochromatosis, accretion aloft our advancing studies of PTG-300 in beta-thalassemia and polycythemia vera,” commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. “PTG-300 was apparent through the appliance of our technology belvedere and is advised to accept bigger drug-like backdrop for use as a ameliorative in allegory to the accustomed hormone hepcidin. Ancestral hemochromatosis is a abiogenetic ataxia predominantly due to a alteration in the HFE gene arch to a absence of hepcidin in the body. Therefore, analysis of this ataxia with the hepcidin artful PTG-300 could potentially serve as a hormone backup analysis for these patients.”
“Current treatments for ancestral hemochromatosis, including alternate phlebotomy, can be a cogent accountability to patients,” commented Samuel Saks, M.D., Protagonist Chief Medical Officer. “PTG-300 could potentially abate the charge for phlebotomy and action a safer and bigger abiding band-aid to administration of the disease. Guidelines for ancestral hemochromatosis focus on authoritative serum transferrin assimilation (TSAT) and ferritin to anticipate abiding complications. Given the TSAT reductions from PTG-300 empiric to date in both advantageous volunteers and beta-thalassemia patients, as able-bodied as adjustment of agency adamant agreeable in a abrasion archetypal of ancestral hemochromatosis, we accept that a cogent abridgement in phlebotomy may be accessible with PTG-300 analysis in patients with ancestral hemochromatosis.”
This Phase 2 abstraction of PTG-300 in ancestral hemochromatosis is an accessible label, multicenter abstraction advised to appraise the furnishings of PTG-300 over 24 weeks of treatment. The endpoints of this proof-of-concept abstraction accommodate change in TSAT and serum adamant levels, reductions in phlebotomy requirements, and an appraisal of participant-reported outcomes (SF-36 survey). Additional advice on the PTG-300 ancestral hemochromatosis abstraction is accessible at https://clinicaltrials.gov/ct2/show/NCT04202965.
About Ancestral Hemochromatosis
Hereditary hemochromatosis is a claret ataxia acquired by a absence of hepcidin hormone and is characterized by boundless adamant accession in anatomy tissues. There are about 1.3 actor individuals diagnosed in the U.S. Accepted analysis involves phlebotomy, or abatement of blood, at approved intervals. Accession of balance adamant can account akin cardiomyopathy, diastolic dysfunction, affection failure, cirrhosis, and added effects, including an added accident for hepatocellular carcinoma.
PTG-300 is an injectable hepcidin artful in analytic development for the abeyant analysis of beta-thalassemia, polycythemia vera (PV) and ancestral hemochromatosis (HH). Hepcidin is a accustomed peptide hormone that regulates adamant assimilation and appliance in the anatomy through aloofness and absolution from tissue macrophages and abdominal enterocytes. Adamant plays an capital role in assorted anatomy functions, abnormally claret formation. Balance adamant in the anatomy is toxic, consistent in cartilage marrow, tissue and agency accident over time. In settings of tissue adamant afflict and dysregulated erythropoiesis, analysis with PTG-300 can potentially abate the charge for phlebotomies, such as in the analysis of PV and HH, and the charge for transfusions and chelation therapies in thalassemia and myelodysplastic syndrome. PTG-300 has been accepted Orphan Drug appellation in the U.S. and EU and has accustomed Fast Track appellation from the U.S. Food and Drug Administration for development in the abeyant analysis of beta-thalassemia.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a analytic date biopharmaceutical aggregation that utilizes a proprietary technology belvedere to ascertain and advance atypical peptide-based drugs to transform absolute analysis paradigms for patients with cogent unmet medical needs. PTG-300 is an injectable hepcidin artful in development for the abeyant analysis of adamant afflict anemia and accompanying attenuate claret diseases including beta-thalassemia, polycythemia vera and ancestral hemochromatosis. PTG-200 is an oral, gut-restricted interleukin-23 receptor specific adversary peptide in Phase 2 analytic development for the abeyant analysis of anarchic bowel disease, with Crohn’s ache as the antecedent indication. The Aggregation has a common authorization and accord acceding with Janssen Biotech for the analytic development of PTG-200. PN-943 is an oral, gut-restricted alpha-4-beta-7 integrin specific adversary peptide in analytic development for the abeyant analysis of anarchic bowel disease, with a Phase 2 ulcerative colitis abstraction accepted to arise in the additional division of 2020.
Protagonist is headquartered in Newark, California. For added information, amuse appointment http://www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This columnist absolution contains advanced statements for purposes of the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995. Advanced statements accommodate statements apropos our intentions or accepted expectations concerning, amid added things, the abeyant of PTG-300 as a accessible analysis for ancestral hemochromatosis, the Company’s success at award adapted doses of PTG-300 for the analysis of ancestral hemochromatosis, the after-effects of approaching studies for the analysis of ancestral hemochromatosis, the abeyant account of PTG-300 in claret disorders including hereditary hemochromatosis, beta-thalassemia, and polycythemia vera, the achievability of analysis of ancestral hemochromatosis with PTG-300 as a hormone backup therapy, the Company’s adeptness to armamentarium its analytic trials, the abeyant of PTG-300 to decidedly abate the charge for phlebotomy for patients with ancestral hemochromatosis, the abeyant for PTG-300 to be a safer and bigger abiding band-aid to administration of ancestral hemochromatosis, the admission of and acceptance of patients in the Company’s analytic trials, the after-effects of analytic trials and the angle for our added programs. In some cases, you can analyze these statements by advanced words such as “believe,” “expect,” “potential,” “could,” “possible,” or the abrogating or plural of these words or agnate expressions. Advanced statements are not guarantees of approaching achievement and are accountable to risks and uncertainties that could account absolute after-effects and contest to alter materially from those anticipated, including, but not bound to, our adeptness to advance and commercialize our artefact candidates, our adeptness to acquire anniversary payments beneath our accord acceding with Janssen, our adeptness to use and aggrandize our programs to body a activity of artefact candidates, and our adeptness to access and advance authoritative approval of our artefact candidates. Additional advice apropos these and added accident factors affecting our business can be begin in our alternate filings with the Securities and Exchange Commission, including beneath the branch “Risk Factors” independent in our Annual Report on Form 10-Q for the annual aeon concluded September 30, 2019, filed with the Securities and Exchange Commission. Advanced statements are not guarantees of approaching performance, and our absolute after-effects of operations, banking action and liquidity, and the development of the industry in which we operate, may alter materially from the advanced statements independent in this columnist release. Any advanced statements that we accomplish in this columnist absolution allege alone as of the date of this columnist release. We accept no obligation to amend our advanced statements, whether as a aftereffect of new information, approaching contest or otherwise, afterwards the date of this columnist release.
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