Arch Biopartners Engages Dalton Pharma Services for GMP Manufacturing of Metablok
TORONTO, Aug. 14, 2018 /CNW/ - Arch Biopartners, Inc., (Arch or the Company) (TSXV: ARCH) (OTCQB: ACHFF) a portfolio-based biotechnology company, today announced it has engaged Dalton Pharma Services (Dalton) to perform the good manufacturing practice (GMP) campaign for Metablok, (LSALT peptide), the Company's drug candidate for preventing acute kidney injury.
Dalton will be responsible for the GMP preparation and filling of Metablok into glass vials through to the release of a clinical drug product. The clinical drug product will then form part of the intravenous kits that will be used to support the Phase I human trial to evaluate Metablok's safety and pharmacokinetic profile. The Phase I trial will serve as a precursor to future Phase II clinical trials to test Metablok's efficacy for several indications, the first being the prevention of acute kidney injury (AKI) often seen in patients undergoing cardiac surgery.
"Dalton is privileged to be supporting this critical GMP campaign, and to play an important role in the development of this innovative peptide drug for the treatment and prevention of acute kidney injury in cardiac surgery patients." said Peter Pekos, CEO and President, Dalton Pharma Services. "The need for an effective therapeutic is badly needed as there is no such treatment currently for the more than 1 million patients that risk kidney damage during these procedures each year."
The Arch team continues to prepare an Investigational New Drug (IND) application for Metablok. "We have taken a significant step forward in the Metablok clinical program with our engagement with Dalton. We are on schedule for producing a GMP drug kit for Metablok to support the first human trial, which is a key component of our IND application that we expect to submit to the U.S. Food and Drug Administration later this year, "said Richard Muruve, CEO of Arch.
Cardiac Surgery-Associated Acute Kidney Injury Acute kidney injury (AKI) occurs in approximately 30% of patients that undergo cardiac surgery with 1% of patients requiring dialysis. Acute kidney injury represents an additional challenge in patients recovering from cardiac surgery as they have higher incidences of mortality, complications in treatment course, and higher risk of complications such as cardiovascular events and infection. Of the patients that require dialysis because of cardiac surgery-associated AKI, many will require lifelong dialysis which increases overall morbidity and mortality.
Inflammation is known to contribute to AKI related to ischemia-reperfusion and other insults to the kidney that may occur in the course of cardiac surgery. Currently, no specific therapies exist to target this condition. Metablok is a novel therapeutic agent that may protect the kidneys and prevent AKI in patients undergoing cardiac surgery.
About Dalton: Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. Dalton brings over 30 years of experience to their client's projects and emphasize quality, speed and flexibility.
Dalton can accelerate a drug development program by integrating drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing and Accelerated Stability Testing, all at a single location that helps Dalton to be adaptable, flexible and cost-effective.
CMO 2016, 2017 and 2018 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflects Dalton's ongoing commitment to their clients, peers and the business community. In 2017 Dalton was re-certified as "A Great Place to Work."
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 has established a diverse portfolio that includes Metablok (LSALT peptide), a potential treatment for inflammation, sepsis and cancer metastasis; AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung, urinary tract or wounds; and, 'Borg' peptide coatings that increase corrosion resistance and decrease bacterial biofilm on various medical grade metals and plastics.
For more information on Arch Biopartners, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com
The Company now has 58,495,179 common shares outstanding following the recent exercise of 30,000 warrants to buy 30,000 common shares at $0.50 per share.
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