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.
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
following the recent exercise of 30,000 warrants to buy 30,000
common shares at $0.50 per share.
Forward-Looking Statements
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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Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
SOURCE Arch Biopartners Inc.