Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 - BioSpace

Posted: 21 Oct 2019 12:00 AM PDT

WHIPPANY, N.J., Oct. 21, 2019 /PRNewswire/ -- Bayer today announced recipients of the inaugural Pulmonary Hypertension Accelerated Bayer (PHAB) Awards, a U.S.-based research grant program created to support clinical research in pulmonary hypertension (PH), with a focus on pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The recipients will receive a combined total of $1 million in grants over a two-year period, making the PHAB Awards one of the largest industry-funded grant programs focused on PAH and CTEPH in the U.S. The eight award recipients were formally announced at a ceremony during the American College of Chest Physicians (CHEST) Annual Meeting in New Orleans on Sunday, October 20, 2019.

(PRNewsfoto/Bayer)

"Supporting a new generation of researchers is imperative to ensure we continue the progress that has been made during the past decade in pulmonary hypertension and its related conditions," said Aleksandra Vlajnic, M.D., Senior Vice President & Head Medical Affairs Americas at Bayer. "Our hope is that the PHAB Awards program will encourage researchers to think creatively about solving the significant treatment and patient care challenges that remain, knowing Bayer is committed to providing the support needed to help bring those ideas to fruition. We want to congratulate all of the applicants on their winning proposals."

The recipients are:

Andrew J. Bryant, M.D., Assistant Professor of Medicine, University of Florida College of Medicine, Gainesville, FL will study the uncertain relationship between myeloid cells (or bone-marrow derived cells), circadian rhythm and PH and apply this knowledge to evaluate the use of existing treatments for patients with PH.
Francisco Contijoch, Ph.D., Assistant Professor, University of California at San Diego, San Diego, CA will study the effectiveness of different imaging modalities to determine if pre-operative, imaging-based prediction of surgical disease level could be utilized to assess risk-benefit of pulmonary thromboendarterectomy (PTE) surgery.
Michael Insel, M.D., Pulmonary Critical Care Fellow, University of Arizona Department of Medicine, Tucson, AZ will study the different causes of shortness of breath in patients who have suffered a pulmonary embolism using invasive cardiopulmonary exercise testing.
Sonia Jasuja, M.D., Fellow Physician, David Geffen School of Medicine at UCLA, Los Angeles, CA will study the use of impedance cardiography, a non-invasive technology measuring cardiac output and stroke volume, to assess risk and response to treatment in patients with PAH or CTEPH.
Manreet Kanwar, M.D., Associate Professor, Allegheny General Hospital, Pittsburgh, PA will study the role of medical therapy, in treating patients with chronic thromboembolic disease (CTED), who have symptoms of shortness of breath, to help understand progression between CTED and CTEPH and evaluate treatment options.
Lea Ann Matura, Ph.D., Associate Professor, School of Nursing, University of Pennsylvania, PA will study alternative treatments, such as Cognitive Behavioral Therapy and Bright Light Therapy, to improve symptoms of PAH, including insomnia, fatigue and physical activity levels.
Yogesh Reddy, M.D., M.Sc., Instructor of Medicine, Mayo Clinic, Rochester, MN will study the prevalence of atypical PAH in elderly patients, as well as their response to therapy using invasive exercise hemodynamic testing.
Maria Trivieri, M.D., Ph.D., Assistant Professor, Icahn School of Medicine at Mount Sinai, New York, NY will work to develop a new in-vitro way to generate human species-specific, and even patient-specific stem cells, to examine the underlying mechanisms of vascular pathogenesis to advance disease understanding, to make greater inroads in the treatment of PAH.

The PHAB Awards recipients were selected by an independent Grants Review Committee, consisting of the following eminent PH leaders:

William Auger, M.D., Temple University Medical Center, Philadelphia, PA
Raymond L. Benza, M.D., FACC, FCCP, Temple University School of Medicine, Cardiovascular Institute, Allegheny Health Network, Pittsburgh, PA
Hunter Champion M.D., Ph.D., Southeastern Cardiology, Columbus, GA
Rajan Saggar, M.D., Ronald Reagan University of California, Los Angeles Medical Center, Los Angeles, CA
Roxana Sulica, M.D., NYU Langone Medical Center, Beth Israel Medical Center, New York, NY
Aaron Waxman, M.D., Ph.D., Brigham and Women's Hospital, Pulmonary Vascular Disease Program, Boston, MA
Melisa Wilson, APRN, ACNP-BC, Florida Hospital Orlando, Center for Pulmonary Hypertension and Cardiovascular Disease, Orlando, FL

"I would like to thank and recognize the Grants Review Committee for their time and commitment, and the PH community in the U.S. for their overwhelming response to the inaugural PHAB Awards," said Sameer Bansilal, M.D., M.S., Medical Director, U.S. Medical Affairs at Bayer. "We look forward to an even greater response next year and encourage eligible applicants to start thinking about submitting their research proposals."

The PHAB Award eligibility, review and category criteria were modeled after the National Institutes of Health (NIH) system; entries were graded on significance, investigator(s), innovation, approach, and environment.

For more information on the PHAB Awards visit: https://www.phab-awards.com/awards/ or e-mail PHAB.awards@bayer.com.

Grants were made on the merits of the research, and research must be posted on ClinicalTrials.gov. Every effort should be made to publish or present study outcomes. If the research is not conducted the grant must be returned.

About Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH, WHO Group 1) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs. Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope. PAH is caused by abnormalities in the walls of the pulmonary arteries.^1,2

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Chronic Thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4) is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart.^3,4 CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material.^5,6 However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.⁷

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.us.

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Media Contact:
David Patti, +1-973-452-6793
Bayer, U.S. Product Communications
david.patti@bayer.com

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:
¹ Galie et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart. 2016;37:67–119.
²American Lung Association. Pulmonary Hypertension. Accessed November 22, 2017. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/pulmonary-hypertension.
³ Piazza G and Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011; 364: 351-360.
⁴ Simonneau G et al. Updated Clinical Classification of Pulmonary Hypertension. Journal of the American College of Cardiology. 2013; 62(25):
⁵ D'Armini M. Diagnostic advances and opportunities in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015; 24: 253–262.
⁶ Kim et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013; 62: D92-9.
⁷ Mathai et al. Quality of life in patients with chronic thromboembolic pulmonary hypertension. Eur Respir J. 2016 Aug; 48(2): 526–537.

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Combo Improves Blood Flow in Pulmonary Arterial Hypertension - Medscape

Posted: 28 Oct 2019 12:34 PM PDT

For patients with newly diagnosed pulmonary arterial hypertension, the combination of macitentan (Opsumit, Actelion Pharmaceuticals) plus tadalafil (Adcirca, Eli Lilly) improves hemodynamics, function, and risk profile, results from the OPTIMA study show.

"This is another demonstration that initial combination therapy is particularly efficacious in patients with PAH," said Olivier Sitbon, MD, PhD, from Université Paris–Sud.

"Combination therapy is becoming the treatment of choice for the vast majority of patients with PAH; here we have another option," he reported at CHEST 2019 in New Orleans.

Results from the 2015 AMBITION study showed that the combination of ambrisentan (Letairis, Gilead Sciences), an endothelin-receptor antagonist, plus tadalafil, a phosphodiesterase type-5 inhibitor, was more effective than monotherapy.

"So we know for the long term, initial combination therapy is efficacious and results in a delay of progression, compared with monotherapy," Sitbon said. In fact, the AMBITION findings led to the approval of the combination of ambrisentan and tadalafil for patients with pulmonary arterial hypertension, as reported by Medscape Medical News.

"But we didn't get any hemodynamic results from that study," he said.

OPTIMA is the first study to show hemodynamic results for combination therapy, he told Medscape Medical News. "Until now, we've had very little information."

With macitentan and tadalafil, "we observed a major hemodynamic improvement," with a decrease in pulmonary muscular resistance of almost 50% and a reduction in pulmonary vascular remodeling of 47%, said Sitbon.

"There was also improvement in cardiac output, a decrease in pulmonary artery pressure, and a major decrease — of about 70% — in the level of NT-proBNP, which is a very important biomarker for disease severity."

"We know it's good news when patients reach a normal level of NT-proBNP," he added.

OPTIMA Trial

The 46 participants in the OPTIMA trial — which was sponsored by Actelion Pharmaceuticals — had been diagnosed with pulmonary arterial hypertension in the previous 6 months, and all were treatment-naïve. All had a WHO functional classification of II or III and a 6-minute walk distance of less than 50 meters (164 feet).

In the study cohort, the condition was idiopathic, heritable, drug- or toxin-induced, associated with connective tissue disease, or associated with HIV infection. Two participants — one with suspected pulmonary veno-occlusive disease who saw no benefit from the drug combination and withdrew from the study and another whose diagnosis was reclassified as coronary heart disease — were excluded from the analysis.

At baseline, right heart catheterization screening showed that mean resting pulmonary arterial pressure was at least 25 mm Hg, pulmonary artery wedge pressure or left ventricular end diastolic pressure was 15 mm Hg or less, and pulmonary vascular remodeling was at least 400 dyne-second per cm⁻⁵ for wedge pressure below 12 mm Hg or at least 500 dyne-second per cm⁻⁵ for wedge pressure from 12 to 15 mm Hg.

There was a 47% reduction in the primary study end point of the ratio of pulmonary vascular remodeling from baseline to 16 weeks (P < .0001). And 87% of the participants had a decrease of at least 30% in that ratio from baseline to week 16.

Mean 6-minute walk distance improved from 352 m (1156 feet) at baseline to 388 m (1273 feet) at week 16 (P = .0008). And median NT-proBNP level decreased from 1456.8 ng/L at baseline to 404.2 ng/L at week 16 (P < .0001).

At week 16, WHO functional classification had not worsened in any study participant, and had improved in 63%. Approximately 70% of participants met the criteria for WHO functional classification I or II at week 16, whereas at baseline, only 22% met the criteria for functional classification II and none met the criteria for functional classification I.

"Our patients clearly improved with this combination," Sitbon reported. "We did not look at quality-of-life indicators, but when you markedly improve hemodynamics and personal capacity, you improve many aspects of daily life."

This is an "encouraging" study, but it "should not be considered an equivalent trial to longer morbidity-driven end-point studies," Victor Test, MD, from Texas Tech University Health Sciences Center in Lubbock, added in a news release.

However, the findings add "strength to the evidence for upfront dual oral therapy," he noted.

CHEST 2019: American College of Chest Physicians Annual Meeting. Presented October 21, 2019.

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