Palatin reports preclinical study results of PL-3994 in respiratory tissue for asthma indications

Palatin Technologies, Inc. (NYSE Amex: PTN) today announced results of preclinical studies in respiratory tissue with PL-3994.  In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

PL-3994 is a proprietary peptide mimetic that binds and activates natriuretic peptide receptor A, a guanylate cyclase.  Naturally occurring natriuretic peptides have been evaluated for bronchodilator activity in previous clinical studies with asthmatics.  Despite positive outcomes, no commercial products have been developed in part, Palatin believes, because of the very short half-life of those molecules.  In earlier Phase 1 clinical studies conducted by Palatin, PL-3994 has been shown to have a significantly longer half-life than endogenous natriuretic peptides, with biological effects attributable to relaxation of smooth muscle seen for up to eight hours following single administrations in man.

Palatin has filed a request for a meeting with the U.S. Food & Drug Administration (FDA) to discuss an Investigational New Drug (IND) application for clinical trials with PL-3994 in asthmatic patients.  Under FDA regulations Palatin anticipates that the meeting will be held within sixty days, and assuming a favorable outcome from the meeting, an IND will be filed shortly thereafter.  Palatin plans to initiate clinical trials with PL-3994 in asthmatics as early as the fourth quarter of this calendar year.  

Commenting on today's news, Trevor Hallam, Ph.D., Palatin's Executive Vice President – Research and Development, stated, "We are excited to expand our PL-3994 program into acute severe asthma, a serious unmet medical need.  Many asthma patients that go to the emergency department with an exacerbation of symptoms have become inadequately responsive to standard bronchodilators such as Beta 2-agonists used in rescue inhalers.  Because PL-3994 causes bronchodilation through a different mechanism of action than existing bronchodilators, we are optimistic that PL-3994 will provide relief to patients for whom existing therapies do not work."