TORONTO, ONTARIO–(Marketwired – Oct. 10, 2017) – Arch Biopartners, Inc., (Arch or the Company) (TSX VENTURE:ARCH)(OTCBB:ACHFF) a portfolio-based biotechnology company, today announced it has engaged CSBio in Menlo Park, California, to begin the manufacturing process for Metablok, the Company’s drug candidate for treating inflammation, cancer metastasis and sepsis.
Arch is planning a Phase I human trial to evaluate Metablok’s safety and pharmacokinetic profile. The phase I study will be followed by Phase II clinical trials to evaluate the efficacy of Metablok in preventing cardiac surgery-associated acute kidney injury.
In pre-clinical studies, Arch scientists have demonstrated Metablok’s ability to prevent acute kidney injury by blocking the inflammatory response triggered by kidney ischemia/reperfusion. Currently, there are no specific or effective treatments to prevent acute kidney injury.
An investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) is currently being prepared by the Metablok team for submission in 2018.
“Acute kidney injury following cardiac surgery is a serious complication that is associated with an increased risk of death and other adverse effects. Advancing the pre-clinical development to prepare Metablok for a human trial is an exciting development for our drug that we believe will have a major clinical impact in patients at risk of acute kidney injury,” said Dr. Daniel Muruve, Chief Science Officer of Arch, Professor of Medicine and Chief of Nephrology at the University of Calgary.
CSBio is currently producing Metablok under good laboratory practice (“GLP”) standards to enable toxicology and pharmacology studies needed to support a pre-IND submission meeting and subsequent IND application with the FDA.
Notes for Editors
Metablok is a novel peptide drug candidate in the Arch development pipeline and a potential treatment for inflammation, sepsis and cancer metastasis.
Inflammation and Acute Kidney Injury
Inflammation is a localized physical condition that involves the activation of the immune system in response to infection, tissue injury, or autoimmunity. Inflammation is involved in the pathogenesis of many diseases and plays a significant role in acute kidney injury. Acute kidney injury due to ischemia/reperfusion occurs in up to 40% of patients undergoing cardiovascular and other major surgeries.
Sepsis and cancer metastasis represent large unmet medical needs in the world today. Sepsis alone occurs in 1 to 2% of all hospitalizations in the US. It affects at least 700,000 individuals per year.
Sepsis is a serious illness caused by the body’s immune response to an infection. White blood cells, or leukocytes, defend the body against toxins and infection. If the immune system activates too many white blood cells to fight the infection, there is a risk of widespread, life threatening inflammation termed “Sepsis”.
Sepsis is known to cause organ damage. Blood clotting during sepsis inhibits blood flow to organs and thus reduces their intake of nutrients and oxygen. In severe cases, one or more organs fail. In the worst cases, infection leads to a dangerous drop in blood pressure, called septic shock. This can quickly lead to the failure of several organs such as lungs, kidneys and liver, causing death.
Permanent organ damage can occur in patients who survive sepsis. Under current standard of care, mortality rates are over 20% for sepsis and over 50% for septic shock.
Cancer is a life threatening disease because of its ability to spread from its original tumour site to other tissues and organs in the body. This process of metastasis occurs through the bloodstream or lymphatic system.
Metastasis is of great importance since most of the cancer deaths are caused by spread of the primary cancer to other sites in the body. Recent evidence shows that 60% to 70% of cancer patients have started the metastatic process by the time of diagnosis. Additionally, patients that do not have tumor spread at diagnosis are at risk for metastatic disease. New therapeutic treatments that protect patients against metastasis would be a major breakthrough in the treatment of cancer.
About CS Bio:
CSBio is a leading peptide and peptide synthesizer manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global biotech community. CSBio’s peptide products and peptide synthesis equipment can be found in peptide production laboratories and pharmaceutical companies worldwide.
About Arch Biopartners
Arch Biopartners Inc. is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch works closely with the scientific community, universities and research institutions to advance and build the value of select preclinical technologies, develop the most promising intellectual property, and create value for its investors.
Arch has established a diverse portfolio that includes AB569, a potential new treatment for antibiotic resistant bacterial infections; Metablok, a potential treatment for inflammation, sepsis and cancer metastasis; MetaMx, which targets elusive brain tumor initiating cells; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease biofilm on various medical grade metals and plastics.
For more information on Arch Biopartners, other public documents Arch has filed on SEDAR and its technologies including, please visit www.archbiopartners.com
The Company has 55,299,679 common shares outstanding.
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