March 3, 2011
/PRNewswire/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced that the U.S. Food and Drug Administration (FDA) has cleared Palatin's request to begin a Phase 2A proof-of-concept human trial under an Investigational New Drug (IND) application using a subcutaneously administered formulation of PL-3994, an NPR-A agonist compound, in development for treatment of acute exacerbations of asthma.
"We are excited about the prospect of advancing PL-3994 into a Phase 2A human trial to treat asthma patients," stated Dr.
, Palatin's Chief Executive Officer. "Existing therapies for acute exacerbations of asthma in patients unresponsive to beta-2 adrenergic receptor agonists have limitations, including typically taking several hours for significant patient improvement. PL-3994, which works through a different pathway than beta-2 adrenergic receptor agonists and other approved bronchodilators, is intended to address this unmet medical need."
Palatin is seeking a development and marketing partner for PL-3994, which would include both the proof-of-concept Phase 2A human trial for asthma and development of an inhalation formulation. Palatin does not intend to initiate either the proof-of-concept human trial or preclinical inhalation toxicity studies unless and until an agreement is reached with a development and marketing partner, or Palatin receives funding to support the proof-of-concept Phase 2A human trial or preclinical inhalation toxicity studies from a third party, such as grant funding from an agency of the federal government.
PL-3994 is an NPR-A agonist compound in development for treatment of acute exacerbations of asthma, heart failure and refractory hypertension. PL-3994 activates NPR-A, a receptor known to play a role in cardiovascular homeostasis. PL-3994 increases plasma cyclic guanosine monophosphate (cGMP) levels, a pharmacological response consistent with the effects of endogenous (naturally produced) natriuretic peptides on cardiovascular function and smooth muscle relaxation.