LEXINGTON, Mass., July 23, 2018 /PRNewswire/ -- Pulmatrix,
Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company
developing innovative inhaled therapies to address serious
pulmonary diseases announced today the formation of the Clinical
Advisory Board (CAB) for Pulmazole (PUR1900) – an inhaled
iSPERSE™ formulation of the anti-fungal drug
itraconazole for the treatment of allergic bronchopulmonary
aspergillosis (ABPA) in patients with asthma. The members of
the CAB are world-renowned experts in the fields of both ABPA and
asthma and will work closely with Pulmatrix to design and implement
future clinical studies of Pulmazole.
"I am very encouraged by the Phase 1 results demonstrating that
it is both feasible to administer itraconazole by inhalation and
further that high levels of the drug may be achieved within the
airways," stated Dr. David Denning,
Professor of Infectious Diseases in Global Health and the Director
of the National Aspergillosis Centre, Manchester, UK, and co-chair of the Pulmazole
CAB. "I believe that Pulmazole has the potential to
significantly improve upon both the efficacy and safety profile of
oral Sporanox, and I look forward to working with the other members
of the advisory board to assist Pulmatrix in advancing the
development of Pulmazole to treat patients with fungal asthma,
focusing initially on ABPA."
The members of the Pulmazole Clinical Advisory Board are as
follows:
Co-Chairs:
David
Denning, FRCP, FRCPath, FIDSA, FMedSci - Professor of
Infectious Diseases in Global Health; President, Global Action Fund
for Fungal Infections; Director, National Aspergillosis Centre,
Manchester, UK
Jim
Roach, MD, FACP, FCCP – Chief Medical Officer,
Pulmatrix
Members:
Ritesh
Agarwal, MD, DM - Professor of Pulmonary Medicine,
Postgraduate Institute of Medical Education and Research,
Chandigarh, India
William J Calhoun, MD -
Professor and Vice Chair for Research, Divisions of Pulmonary,
Critical Care and Sleep, and Allergy/Immunology. Department
of Medicine at University of Texas
Medical Branch, Galveston, TX
Mario
Castro, MD, MPH, FCCP - Professor of Medicine,
Pediatrics, and Radiology, Division of Pulmonary and Critical Care
Medicine at the Washington University
School of Medicine in St. Louis,
MO
Jonathan Corren, MD - Associate Clinical
Professor of Medicine and Pediatrics, David
Geffen School of Medicine at UCLA, Los Angeles,
CA
Cendrine Godet, MD - Doctor of Infectious
Diseases and Pulmonary Medicine at Poitiers University Hospital,
France; Coordinator of the French
National Board for Chronic Fungal Infection and Secretary of the
European CPAnet Board for Chronic Pulmonary Aspergillosis
Richard
B. Moss, MD - Professor Emeritus, Pediatrics-Pulmonary
Medicine at Stanford University School
of Medicine, Stanford, CA
Russell
Settipane, MD - Clinical Professor of Medicine at Brown
Medical School, Director of the Allergy & Asthma Center,
Providence, RI; Associate Editor
of Allergy & Asthma Proceedings and the Journal of Precision
Respiratory Medicine, President Eastern Allergy and Eastern
Pulmonary Conferences
David
A. Stevens, MD, FACP, FAAM, FIDSA Professor Emeritus,
Infectious Diseases and Geographic Medicine at Stanford University School of Medicine,
Stanford, CA; President,
California Institute for Medical Research, San Jose, CA
Peter
Wark, BMed PhD FRACP FThorSoc - Conjoint Professor,
Centre for Healthy Lungs, University of Newcastle & Department
of Respiratory and Sleep Medicine John Hunter Hospital, New Lambton
NSW, Australia
Michael
Wechsler, MD, MMSc - Professor of Medicine, Director,
NJH Cohen Family Asthma Institute, Department of Medicine, National
Jewish Health, Denver, CO
Additional background on the CAB members can be found on the
Pulmatrix website.
"With the successful completion of our Phase 1/1b Pulmazole trial, we are excited to move on to
our planned Phase 2 trial in the fourth quarter of this year
utilizing a study design informed by the expertise of our Clinical
Advisory Board. The insight and expertise provided by our advisors
will be critical as we advance the development of Pulmazole in
ABPA, and we are honored and extremely fortunate to welcome such
distinguished clinicians to the team," stated Jim Roach, MD, Chief Medical Officer of
Pulmatrix.
About ABPA
ABPA is a disease that occurs most often
in patients with underlying asthma or cystic fibrosis, and it is
characterized by an exaggerated allergic hypersensitivity response
of the immune system to the fungus Aspergillus colonizing and
growing in the airways. Oral itraconazole (Sporanox®) is currently
used as an adjunctive treatment to corticosteroids in ABPA
patients. However, its use is limited by poor bioavailability,
variable pharmacokinetics, and toxicity concerns related primarily
to the risk of gastrointestinal and cardiac side effects, as well
as extensive drug-drug interactions. The Pulmatrix Pulmazole
program is the first inhaled dry powder version of itraconazole
known to the company to be advanced into clinical development, with
the goal of improving upon the known safety and efficacy profile
associated with oral Sporanox by delivering the drug directly to
the lung. Third party research sponsored by Pulmatrix
suggests that physician use of antifungals, with oral steroids, may
more than double with the introduction of an inhaled
itraconazole. This highlights the significant unmet need for
new safe and effective antifungal therapies to treat asthmatic
patients with ABPA.
About Pulmatrix
Pulmatrix is a clinical stage
biopharmaceutical company developing innovative inhaled therapies
to address serious pulmonary disease using its patented iSPERSE™
technology. The Company's proprietary product pipeline is focused
on advancing treatments for serious lung diseases, including
Pulmazole, an inhaled anti-fungal for patients with allergic
bronchopulmonary aspergillosis ("ABPA"), and PUR1800, a narrow
spectrum kinase inhibitor for patients with obstructive lung
diseases including asthma and chronic obstructive pulmonary disease
("COPD"). In addition, Pulmatrix has partnered with Vectura Group
plc to develop Pulmatrix's long-acting muscarinic antagonist drug
candidate, PUR0200, for COPD for the U.S. market. Pulmatrix's
product candidates are based on iSPERSE™, its proprietary
engineered dry powder delivery platform, which seeks to improve
therapeutic delivery to the lungs by maximizing local
concentrations and reducing systemic side effects to improve
patient outcomes.
FORWARD-LOOKING STATEMENTS
Certain statements in this
press release that are forward-looking and not statements of
historical fact are forward-looking statements within the meaning
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The Company cautions that such statements
involve risks and uncertainties that may materially affect the
Company's results of operations. Such forward-looking statements
are based on the beliefs of management as well as assumptions made
by and information currently available to management. Actual
results could differ materially from those contemplated by the
forward-looking statements as a result of certain factors,
including but not limited to the ability to establish that
potential products are efficacious or safe in preclinical or
clinical trials; the ability to establish or maintain
collaborations on the development of therapeutic candidates; the
ability to obtain appropriate or necessary governmental approvals
to market potential products; the ability to obtain future funding
for developmental products and working capital and to obtain such
funding on commercially reasonable terms; the Company's ability to
manufacture product candidates on a commercial scale or in
collaborations with third parties; changes in the size and nature
of competitors; the ability to retain key executives and
scientists; and the ability to secure and enforce legal rights
related to the Company's products, including patent protection. A
discussion of these and other factors, including risks and
uncertainties with respect to the Company, is set forth in the
Company's filings with the Securities and Exchange Commission,
including its annual report on Form 10-K filed by the Company with
the Securities and Exchange Commission on March 13, 2018, as may be supplemented or amended
by the Company's Quarterly Reports on Form 10-Q. The Company
disclaims any intention or obligation to revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Investor
Contact
|
Robert Clarke,
CEO
|
William Duke,
CFO
|
(781)
357-2333
|
(781)
357-2333
|
rclarke@pulmatrix.com
|
wduke@pulmatrix.com
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/pulmatrix-announces-the-formation-of-the-pulmazole-clinical-advisory-board-to-support-future-development-300684801.html
SOURCE Pulmatrix, Inc.