Breaking News
April 18, 2019 - Scientists enter research collaboration to find a cure for cancer
April 18, 2019 - Study to compare benefits of tai chi and mindfulness meditation on MS symptoms
April 18, 2019 - Gestational diabetes during pregnancy may increase risk of type 1 diabetes in children
April 18, 2019 - Is a New Remedy for Body Odor on the Horizon?
April 18, 2019 - Orthostatic hypotension – Genetics Home Reference
April 18, 2019 - Healing the heartbreak of stillbirth and newborn death
April 18, 2019 - Conference to highlight advances in human immune monitoring, bioinformatics | News Center
April 18, 2019 - Bacteria use viruses for self-recognition, study reveals
April 18, 2019 - New adhesive patch could help reduce post-heart attack muscle damage
April 18, 2019 - Researchers analyze the effects of dark play in a serious video game
April 18, 2019 - Filial cannibalism and offspring abandonment may be forms of parental care
April 18, 2019 - Two proteins act in concert to maintain a healthy heart in mice, shows study
April 18, 2019 - Scientists create a functioning 3D printed heart
April 18, 2019 - Non-invasive vagus nerve stimulation improves disease symptoms in patients with rheumatoid arthritis
April 18, 2019 - Majority of men struggle to understand diagnosis and treatment of prostate cancer
April 18, 2019 - Researchers create new small molecules that may combat equine encephalitis viruses
April 18, 2019 - Animal-assisted therapy improves social behavior in patients with brain injuries
April 18, 2019 - Some viruses help protect harmful bacteria in CF patients | News Center
April 18, 2019 - Outpatient healthcare providers inappropriately prescribe antibiotics to 40% of patients
April 18, 2019 - Men who have a resting heart rate of 75 bpm are twice as likely to die early
April 18, 2019 - Novel serum biomarkers to detect NAFLD-related fibrosis
April 18, 2019 - New study delves deeper into individual genomic differences than ever before
April 18, 2019 - Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
April 18, 2019 - Emotional mirror neurons found in rats
April 18, 2019 - Sylvia Plevritis appointed chair of biomedical data science | News Center
April 18, 2019 - Yeast strain provides manufacturing boost to low-calorie sweetener derived from lactose
April 18, 2019 - C-Path and CDISC release global Therapeutic Area Standard for HIV research
April 18, 2019 - Integrating AI to analyze imaging data allows early recognition of heart disease
April 18, 2019 - Low-cost, high-speed algorithm may allow animal-free chemical toxicity testing
April 18, 2019 - HPV-negative cervical cancers are more aggressive with worse prognosis
April 18, 2019 - AI detects prostate cancer with same level of accuracy as experienced radiologists
April 18, 2019 - Study resolves sex differences in psychiatric illness risk
April 18, 2019 - Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
April 18, 2019 - Cocktail of common antibiotics can fight resistant E. coli
April 18, 2019 - Persis Drell to give keynote address at medical school diploma ceremony | News Center
April 18, 2019 - EpicTogether: Remembering Our Why
April 18, 2019 - Study identifies novel loci contributing to asthma susceptibility in adults
April 18, 2019 - Gut bacteria and pregnancy
April 18, 2019 - New study finds that screening could help prevent rare types of cervical cancer
April 17, 2019 - Spatial orgnization of the genome can be altered using small molecules
April 17, 2019 - AEDs Tied to Higher Pneumonia Risk in Alzheimer Patients
April 17, 2019 - Telemedicine tied to more antibiotics for kids, study finds
April 17, 2019 - Two medical students awarded 2019 Soros Fellowships for New Americans | News Center
April 17, 2019 - Sociologist Constance A. Nathanson Awarded Guggenheim Fellowship
April 17, 2019 - Empathy and hormones could account for aggressive behavior in children, shows study
April 17, 2019 - Researchers develop oral appliance to help sufferers of sleep apnea
April 17, 2019 - Neuronal transport factor detects its target transcripts in more complex manner than previously thought
April 17, 2019 - New drug-delivery system senses high oxidant levels, responds to body chemistry and environment
April 17, 2019 - Health Tip: Horseback Trail Riding Safety
April 17, 2019 - Scientists outline the promises and pitfalls of machine learning in medicine
April 17, 2019 - $12 million grant renewal for flu vaccine research | News Center
April 17, 2019 - Lisa Kachnic, MD, Joins Columbia University as Chair of Radiation Oncology
April 17, 2019 - New study sheds light on how extreme temperature hampers spermatogenesis in insects
April 17, 2019 - Study tests high-tech, non-pharmaceutical way to address ADHD and distractibility
April 17, 2019 - New EZ-2 evaporator for clinical biochemistry sample preparation
April 17, 2019 - Fat shaming celebrities may make women more judgemental about being overweight
April 17, 2019 - Magic mouthwash effectively reduces mouth sore pain caused by radiation therapy
April 17, 2019 - CBD could help slip medications into the brain
April 17, 2019 - Scientists characterize 2017 pneumonic plague outbreak in Madagascar
April 17, 2019 - Human iPSC-derived MSCs from aged individuals acquire a rejuvenation signature
April 17, 2019 - Gun Research Is Suddenly Hot
April 17, 2019 - Employee wellness programs provide little health benefits
April 17, 2019 - Cannabis users could be more tolerant to anesthesia agents
April 17, 2019 - Study suggests new approach to treat renal fibrosis
April 17, 2019 - Green roofs may improve indoor air quality, study shows
April 17, 2019 - Selumetinib Granted U.S. Breakthrough Therapy Designation in Neurofibromatosis Type 1
April 17, 2019 - Fasting-mimicking diet holds promise for treating people with inflammatory bowel disease
April 17, 2019 - Daily cannabis use significantly higher among individuals with serious psychological distress
April 17, 2019 - Victims of bullying have greater chances of mental health problems, unemployment in later life
April 17, 2019 - Strategies to achieve greater vaccination coverage throughout Europe
April 17, 2019 - Online atlas created to identify, classify protein signatures present at AML diagnosis
April 17, 2019 - £1.8 million award to boost Crohn’s disease research
April 17, 2019 - Oxytocin blocks excess drinking in alcohol-dependent rats
April 17, 2019 - Rutgers researchers identify new factor essential for maintaining stem cells in the brain and gut
April 17, 2019 - Universal late pregnancy ultrasound improves health of mothers, babies and could be cost saving
April 17, 2019 - Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
April 17, 2019 - Stopping inflammation from becoming chronic
April 17, 2019 - Planned Parenthood’s ‘Risky Strategy’ To Update Its Image
April 17, 2019 - Common sleep myths may pose a significant public health threat
April 17, 2019 - Indicators of despair rising among Americans entering midlife
Pulmatrix Announces First Subject Dosed in Phase 1 Clinical Trial of Pulmazole – an Inhaled Dry-Powder iSPERSE™ Formulation of Itraconazole

Pulmatrix Announces First Subject Dosed in Phase 1 Clinical Trial of Pulmazole – an Inhaled Dry-Powder iSPERSE™ Formulation of Itraconazole

image_pdfDownload PDFimage_print

LEXINGTON, Mass., Feb. 12, 2018 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases announced today that the single dose escalation phase of the first-in-human study 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 – has commenced.

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 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.

This phase 1/1b study is being conducted in healthy subjects and patients with mild to moderate stable asthma. The study will include single ascending dose (SAD) and multiple ascending dose (MAD) arms in normal healthy volunteers (NHV) to assess safety, tolerability, and pharmacokinetics (PK). A third study arm will evaluate safety and tolerability in patients with mild to moderate stable asthma and will also include PK analysis of itraconazole levels in the blood and sputum following administration of a single dose of oral itraconazole (Sporanox; 200 mg itraconazole) or Pulmazole (20 mg itraconazole) in a crossover study design.

“Dosing our first subject with Pulmazole and entering the clinic represents a major milestone for this program commented Jim Roach, M.D., Chief Medical Officer of Pulmatrix. In addition to generating the requisite safety and tolerability data from this study to advance dosing of Pulmazole into asthmatic patients with ABPA, we anticipate that the collective pharmacokinetic data obtained in Phase 1 will further corroborate the key PK preclinical findings reported last week at the 8th Advances Against Aspergillosis Conference in Lisbon, Portugal – namely, that Pulmazole can provide higher lung exposure and lower systemic exposure than oral Sporanox.”

The study is planned to include up to 42 subjects in the SAD/MAD evaluation in NHV and 16 asthmatics in the crossover study. The company expects that top line results will be available in mid-2018.

Robert Clarke, Ph.D., Chief Executive Officer of Pulmatrix, added “The initiation of our Pulmazole clinical trial is important validation of our iSPERSE dry powder technology as the second program to advance into the clinic along with PUR0200. We look forward to advancing Pulmazole and our iSPERSE pipeline to improve the treatment approaches for patients with unmet medical needs.”

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 (PUR1900), an inhaled anti-fungal for patients with ABPA, and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and COPD. In addition, Pulmatrix has partnered with Vectura Group plc to develop Pulmatrix’s 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 10, 2017, 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.

Source: Pulmatrix, Inc.

Posted: February 2018

About author

Related Articles