- Confirms Focus on Developing INOpulse® Nitric Oxide Therapy for Patients with Pulmonary Hypertension -
- Headcount and Costs Substantially Reduced -
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
Biographical information regarding the above named individuals may be found on the Company's website at: http://www.bellerophon.com/about/management-team.
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
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.
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.
CONTACT: At Bellerophon:
Amy Edmonds, Vice President Head of Clinical Operations & Administration (908) 574-4765 At Rx Communications Group: Melody Carey(917) 322-2571