Here's the PTN version of the news posted by Tuck. To me, this is beginning to look like a typical Paramount/Aries/Rosenwald act........
Thursday May 31, 7:31 am Eastern Time
Press Release
Palatin Technologies Reports PT-141 Phase 1 Clinical
Results
PRINCETON, N.J.--(BUSINESS WIRE)--May 31, 2001--Palatin Technologies, Inc.
(AMEX: PTN - news) today announced positive results from its Phase 1 clinical safety study
of PT-141, the company's lead investigational drug under study for the treatment of male
erectile dysfunction (ED).
The trial was designed as a double blind, placebo-controlled, dose escalation study to
evaluate the safety and pharmacokinetics (absorption of drug and blood plasma level of
drug) at various doses and determine the maximum tolerated dose (MTD) in 56 normal
volunteers. PT-141 was delivered as a nasal spray.
Participants in the study tolerated treatment well at all dose levels and the MTD was not
identified. There were no significant changes in blood pressure, heart rate or respiration rate
in treated patients. Investigators reported no serious side effects, including no observations of
nausea, vomiting, dizziness, hypotension or syncope (loss of consciousness). Results of the
study indicate the rapid appearance (within 5 minutes) of PT-141 in the blood, with
maximum levels reached at approximately 30 minutes. In addition, analysis of the preliminary
pharmacokinetic results indicates that the nasal formulation should be capable of delivering
therapeutic levels of PT-141 in a rapid and consistent manner.
The Company also reported that although efficacy was not a primary end point of the Phase
1 study, which did not include sexual stimulation, a significant number of erections were
observed at one dose level. These preliminary observations will need to be confirmed in
upcoming efficacy studies.
Palatin Chief Executive Officer and President Carl Spana, Ph.D. stated ``We are very
pleased with the results of this study, which demonstrated a very positive safety profile for
PT-141. The study generated significant data relating to the nasal absorption of PT-141 that
gives us confidence that nasal delivery of the drug is a very viable commercial option. As a
result, we are very excited about advancing the clinical development of PT-141 to a Phase 2
efficacy trial in patients with ED, which should begin in mid-2001.''
PT-141 is a peptide analog of (alpha)-MSH ((alpha)-melanocyte-stimulating hormone). Scientists have determined that
receptors for this class of molecules (melanocortin receptors) play a role in several behaviors, some of which include appetite
and sexual arousal. Recent findings indicate the effects on sexual function may be stimulated through melanocortin receptors in
the brain. As a result, Palatin believes PT-141 has the potential to offer a unique treatment for both male and female sexual
dysfunction. In addition, the Company plans to conduct a Phase 2 safety and efficacy study of PT-141 in female patients in the
4th quarter of this calendar year.
Palatin Technologies, Inc. is a development-stage biopharmaceutical company with pharmaceutical products in development
using its enabling peptide platform technology, MIDAS. Additionally, the Company is developing a product for infection
imaging based on its proprietary radiolabeled monoclonal antibody. For further information visit the Palatin web site at
www.palatin.com.
Statements about the Company's future expectations, including development and regulatory plans, and all other statements in
this document other than historical facts, are ``forward-looking statements'' within the meaning of Section 27A of the Securities
Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation
Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created
thereby.
Palatin's actual results may differ materially from its historical results of operations and those discussed in the forward-looking
statements for various reasons, including, but not limited to the Company's ability to carry out its business plan, successful
development and commercial acceptance of its products, ability to fund development of technology, the risk that products may
not result from development activities, protection of its intellectual property, ability to establish and successfully complete clinical
trials for product approval, need for regulatory approvals, dependence on it partners for development of certain projects, and
other factors discussed in the Company's periodic filings with the Securities and Exchange Commission. The Company is not
responsible for events not updated after the date on this press release.
Contact:
Palatin Technologies, Inc.
Carl Spana, Ph.D., 609/520-1911
cspana@palatin.com
Stephen T. Wills, CPA, MST, 609/520-1911
swills@palatin.com
or
Kureczka/Martin Associates (Media)
Joan Kureczka, 415/821-2413
Jkureczka@aol.com
Ellen Martin, 510/832-2044 |
