Healthcare Industry News: cardiopulmonary
News Release - September 15, 2015
Bellerophon Therapeutics Announces Leadership Team ChangesConfirms Focus on Developing INOpulse(R) Nitric Oxide Therapy for Patients with Pulmonary Hypertension
Headcount and Costs Substantially Reduced
HAMPTON, N.J., Sept. 15, 2015 -- (Healthcare Sales & Marketing Network) -- Bellerophon Therapeutics, Inc. (BLPH), a clinical stage biotherapeutics company, today announced changes to its leadership team to align with the Company's focus of progressing its nitric oxide therapy program for patients suffering from Pulmonary Hypertension (PH), using Bellerophon's proprietary INOpulse(R) delivery system.
The Company's new leadership team, effective immediately, consists of:
- Jonathan Peacock, Chairman and Chief Executive Officer
- David Abrams, Principal Financial Officer
- Martin Dekker, Head of Device Engineering and Supply
- Amy Edmonds, Head of Clinical Operations and Administration
- Peter Fernandes, Chief Regulatory and Safety Officer
- Deborah A. Quinn, M.D., Chief Medical Officer
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, "The leadership team announced today brings decades of experience in Pulmonary Hypertension, clinical operations, electro mechanical device production and development, as well as extensive knowledge and success in navigating global regulatory processes. Additionally, we have substantially streamlined our internal cost structure and expect to complete the first of two Phase 3 trials of INOpulse in Pulmonary Arterial Hypertension (PAH) with our existing cash resources. We look forward to recruiting our first patient in this trial before the end of 2015."
Clinical Program Focus
The focus of the Company's clinical program is the continued development and commercialization of its nitric oxide therapy for patients with PH, using its proprietary delivery system, INOpulse -- with PAH representing the lead indication.
As noted in the Company's second quarter press release, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have accepted Bellerophon's Phase 3 development plan and management expects a Special Protocol Assessment (SPA) to be issued by the FDA within the next few weeks. The Company plans to conduct two confirmatory Phase 3 clinical trials of INOpulse in PAH, enrolling the first patient in the first of these two trials later this year. The primary endpoint for each trial will be the Six Minute Walk Distance test, with Time to Clinical Worsening as a secondary endpoint.
The second indication for INOpulse is PH associated with Chronic Obstructive Pulmonary Disease (PH-COPD). Over the last year, testing conducted by Bellerophon has demonstrated, in an acute setting, the ability of pulsed nitric oxide to reduce PH for COPD patients and to improve blood volume in the blood vessels within the lung. In order to build on this data, the Company plans to conduct further proof-of-concept work with COPD patients over the next 12 months to test the ability of INOpulse therapy to improve exercise capacity by reducing PH.
Bellerophon's clinical team is also planning to initiate early proof-of-concept work to treat PH associated with Pulmonary Fibrosis. As with COPD, this is an area of PH caused by constriction of the blood vessels for which no treatment currently exists. Other diseases for which patients suffer PH and for which INOpulse therapy may be useful include chronic thromboembolic pulmonary hypertension (CTEPH), a distinct pulmonary vascular disease caused by chronic obstruction of major pulmonary arteries; PH associated with sarcoidosis, a condition caused by the growth of tiny collections of inflammatory cells in different parts of the body, including the lungs; and, PH associated with pulmonary edema from high altitude sickness.
As of June 30, 2015, the Company had cash, cash equivalents and restricted cash of $54.7 million and short-term investments of $4.2 million. Management believes that its existing cash resources will be sufficient to fully fund the first of its two PAH Phase 3 trials, which should be completed by the first half of 2018.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The Company is currently developing two product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of PAH, for which the Company intends to commence Phase 3 clinical trials in 2015, and the other for the treatment of PH-COPD, which is in Phase 2 development. The Company is also reviewing alternative paths forward for its Bioabsorbable Cardiac Matrix program. For more information, please visit www.bellerophon.com.
Any statements in this press release about the Company's future expectations, plans and prospects, including statements about the clinical development of its product candidates; the timing of initiation, completion and availability of data from its clinical trials; and expectations regarding the sufficiency of its cash balance to fund clinical trials, operating expenses and capital expenditures; and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of Bellerophon's most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
Source: Bellerophon Therapeutics
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