Arch Biopartners Completes Pre-IND Meeting with U.S. FDA on LSALT Peptide for Preventing Acute Kidney Injury in Cardiac Surgery Patients
TORONTO, May 08, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (Arch or the Company) (TSX Venture:ARCH) (OTCBB:ACHFF), announced today it completed a successful pre-IND (Investigational New Drug) meeting via teleconference on April 18 with members of U.S.
Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products and the Office of Clinical Pharmacology. The FDA members addressed questions from the Arch team and discussed key components of the planned IND application for Metablok (“LSALT peptide”), Arch’s novel drug candidate to prevent acute kidney injury during cardiac surgery.
Currently, there are no specific treatments for the prevention of acute kidney injury.
“During the Pre-IND meeting the FDA provided us confirmation on the pre-clinical data and content of our upcoming IND application. Over the next few months we will complete our original toxicology plan, finalize our IND application and continue to prepare for the phase I human trial for the LSALT peptide,” said Dr. Daniel Muruve, Chief Science Officer of Arch.
Grant of Options
Arch also announced today the Company’s board has granted a total of 1,200,000 stock options to its directors and officers pursuant to the Company’s stock option plan and the requirements of the TSX Venture Exchange (TSXV). The grant to the directors represents their total remuneration during the current year for serving on the board until the next annual meeting of shareholders April 1, 2019. Each of the stock options is exercisable into one common share of the Company for a period of ten years, exercisable at $0.78 per share. The grant of options will be subject to all necessary regulatory approvals.
About Metablok (LSALT peptide)
Metablok (renamed “LSALT peptide” in Arch communications with FDA) is a novel peptide drug candidate in the Arch development pipeline and a potential treatment for the following highly problematic indications: (i) inflammation, (ii) sepsis and (iii) 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 30% of patients undergoing cardiovascular and other major surgeries.
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; LSALT, 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, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com
The Company has 57,799,679 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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