Arch Biopartners Forms New Subsidiary to Pursue a Phase I Trial in Australia for Metablok (LSALT Peptide)
TORONTO, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today announced it has formed a 100% owned subsidiary in Australia, named Arch Clinical Pty Ltd, to pursue an application to perform a phase I safety trial in Australia for Metablok, the Company’s lead drug candidate for treating acute kidney injury.
The Arch team has started the human trial application process with the Alfred Health Human Research Ethics Committee (HREC). The draft application was accepted for registration on December 10, 2018 and will be followed by the full submission and review in early January 2019. A decision regarding trial approval is expected before February 2019.
The Phase I study will be a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok (LSALT Peptide) in healthy participants. A successful Phase I trial will be followed by a Phase II trial to investigate Metablok’s efficacy in the prevention of acute kidney injury in cardiac surgery patients.
Arch Biopartners Provides Toxicology Update for Metablok
TORONTO, Oct. 29, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today provided an update on the general results from toxicology and pharmacology studies evaluating Metablok, the Company’s lead drug candidate for treating acute kidney injury.
Arch Biopartners Announces Completion of GMP Manufacturing of Metablok Vials
TORONTO, Sept. 26, 2018 /CNW/ - Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH) (OTCQB: ACHFF) today announced that Dalton Pharma Services (Dalton) has completed the good manufacturing practice (GMP) glass vial filling stage for Metablok, the Company's lead drug candidate for preventing acute kidney injury.
Over the next six to eight weeks Dalton will be completing the quality control process which will culminate with the release of a clinical drug product to be used in a phase I safety trial for Metablok.
Arch awaits the completion of ongoing toxicology and pharmacology studies at Nucro-Technics in November before confirming the start date of the phase I human trial.
Arch is currently finalizing the planning of the Phase I trial including the selection of a clinical site. Arch plans to make further disclosures when such details are confirmed.
Cardiac Surgery-Associated Acute Kidney Injury
Acute kidney injury (AKI) occurs in approximately 30% of patients that undergo cardiac bypass surgery with 1% of patients requiring dialysis. Currently, no specific therapies exist to prevent AKI. Worldwide, there are over one million patients per year that have cardiac surgery procedures.
AKI 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. Metablok is a novel therapeutic agent that may protect the kidneys and prevent AKI in patients undergoing cardiac surgery.
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.
For Dalton's full range of in-house services including cGMP sterile fill/finish services please visit www.dalton.com.
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.
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management's estimates or opinions change.
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SOURCE Arch Biopartners Inc.