DiaMedica Announces Formation of Development Advisory Group for Its DM-199 and DM-204 Diabetes Products
November 29 2011 - 9:00AM
Marketwired
DiaMedica Inc. (TSX VENTURE:DMA) a biopharmaceutical company
focused on the development of novel treatments for Type 1 and Type
2 diabetes announces the formation of a development advisory group
for its DM-199 and DM-204 products for the treatment of Type 1 and
Type 2 diabetes. The advisory group consists of Dr. Joy Cavagnaro,
Dr. Patrick Gearing, and Mr. Larry Johnson; industry experts in the
areas of pharmacology and toxicology, manufacturing and regulatory
affairs.
"We are pleased to welcome Dr. Cavagnaro, Dr. Gearing, and Mr.
Johnson to our product development advisory group. They bring
together significant industry experience in protein-based diabetes
therapeutics from development, through regulatory approval and
commercialization. They have all worked at or closely with the US
Food and Drug Administration (FDA) with numerous biotechnology and
pharmaceutical companies on successful drug approvals and are now
guiding DiaMedica towards hitting its product development
milestones," said Rick Pauls, Chief Executive Officer of
DiaMedica.
Biographies:
Joy Cavagnaro, PhD, DABT, ATS. Pharmacology and Toxicology
Dr. Cavagnaro assists DiaMedica in the design and implementation
of pre-clinical toxicology studies to access safety, tolerability
and pharmacokinetics of protein-based therapies. Dr. Cavagnaro is
President and Founder of Access BIO consultancy specializing in
pre-clinical pharmacology and toxicology programs and science-based
regulatory strategies to support Phase I clinical trials. She has
over 25 years of experience in biotech. Previously, Dr. Cavagnaro
served as Vice President of Regulatory Affairs at Human Genome
Sciences, Inc. and spent close to a decade at the FDA Center for
Biologics Evaluation and Research (CBER), including serving as
Senior Pharmacologist & Director of Quality Assurance Office of
the Center Director. While at the FDA, Dr. Cavagnaro was
instrumental in establishing key policy, and guidance documents for
biologic-based products and served as rapporteur for the "ICH S6
Guidance on Preclinical Safety Evaluation of Biotechnology-derived
Pharmaceuticals". Additional responsibilities included review of
100s of INDs and 6 licensing applications. Prior to the FDA, Dr.
Cavagnaro was a Senior Staff Scientist, Department of Toxicology at
Covance, overseeing pre-clinical pharmacology and toxicology client
studies of biotechnology products. Dr. Cavagnaro is a Diplomate
American Board of Toxicology and a Fellow Academy of Toxicological
Sciences. www.accessbio.com
Patrick Gearing, PhD. cGMP Manufacturing and CMC Product
Development
Dr. Gearing provides critical technical and regulatory advice on
the manufacturing of cGMP quality biologic-based therapeutics to
DiaMedica. Dr. Gearing has a well-established track record of
working with clients to achieve successful process development and
manufacture of cGMP protein therapeutics appropriate for clinical
trials. Dr. Gearing routinely works with world-leading contract
manufacturing organizations (CMOs), using his 19 years of industry
experience to help clients overcome development and manufacturing
challenges unique to each protein. Dr. Gearing has product
development experience in several regulatory jurisdictions
including the US, Europe, Japan, Canada and Australia, thereby
being able to provide sound product development advice. Prior to
founding Ridge Biotechnology, Dr. Gearing was Director of
Pharmaceutical Development and Quality Systems at Seattle Genetics,
Inc., helping to guide the development of their monoclonal cancer
antibody pipeline. Additional industry experience also includes
positions at Coulter Pharmaceutical, Inc., PDL BioPharma, Inc., and
Immunex Corp. (Amgen). www.ridgebiotechnology.com
Larry Johnson, MSc. Regulatory Affairs
Mr. Johnson provides expertise in the interaction with
regulatory agencies, including the FDA, EMA, and Health Canada, to
achieve clinical and marketing approvals. Mr. Johnson has over 35
years of experience in working with over 50 international and
US-based pharmaceutical companies at all stages of product
development (pre-clinical, clinical and market approval stages) to
expedite development. This has included assisting with the filing
of over 30 INDs, NDAs for drug products, and PLAs for
biologic-based products. He has also participated in several
hundred meetings with the FDA and other regulatory agencies on
behalf of clients. Additionally, Mr. Johnson assists companies in
the development of compliance procedures, standards and
documentation (GLP, GCP, GMP) appropriate to the stage of product
development. Previously, Mr. Johnson was Responsible Head and
Director of Regulatory Affairs at Amgen, Inc., helping to obtain
its first product approval; he continued working closely with the
company for over 16 years as a regulatory consultant. Mr. Johnson
has also been employed by Abbott Laboratories and the US Centers
for Disease Control. www.biofinity.org
About DiaMedica
DiaMedica is a biopharmaceutical company that has developed
novel therapeutic compounds aimed to improve the lives of patients
with diabetes and other major, medically-unmet diseases.
DiaMedica's lead compound, DM-199, represents a novel approach to
treating Type 1 and Type 2 diabetes by demonstrating significant
results against three major aspects of these diseases: 1) halting
the autoimmune attack on beta cells; 2) proliferating insulin
producing beta cells and 3) improving glucose control.
DiaMedica is also developing a monoclonal antibody, DM-204. In
pre-clinical studies, DM-204 significantly improved glucose control
and decreased blood pressure.
The company is listed on the TSX Venture Exchange under the
trading symbol 'DMA'.
Caution Regarding Forward-Looking Information
The statements made in this press release that are not
historical facts contain forward-looking information that involves
risk and uncertainties. All statements, other than statements of
historical facts, which address DiaMedica's expectations, should be
considered forward-looking statements. Such statements are based on
management's exercise of business judgment as well as assumptions
made by and information currently available to management. When
used in this document, the words "may", "will", "anticipate",
"believe", "estimate", "expect", "intend" and words of similar
import, are intended to identify any forward-looking statements.
You should not place undue reliance on these forward-looking
statements. These statements reflect a current view of future
events and are subject to certain risks and uncertainties as
contained in the Company's filings with Canadian securities
regulatory authorities. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results could differ materially from those
anticipated in these forward-looking statements. The Company
undertakes no obligation, and does not intend, to update, revise or
otherwise publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of any unanticipated events.
Although management believes that expectations are based on
reasonable assumptions, no assurance can be given that these
expectations will materialize.
Contacts: DiaMedica Inc. Rick Pauls President & CEO
204.477.7590 204.453.3745 (FAX)rpauls@diamedica.com
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