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This article by Barbara Fox was prepared for the October 2, 2002 edition of U.S. 1 Newspaper. All rights reserved.

Palatin’s Approach: Dysfunction Drugs

Palatin Technologies, a development-stage biopharmaceutical

company in Cranbury, joins NexMed in trying to develop therapies for

both women and men, but whereas NexMed is working on a topically applied

cream or liquid, Palatin uses a nasal spray that stimulates receptors

in the central nervous system rather than acting directly on the vascular

system.

"Our pharmaceutical therapeutic, PT-141, is a nasally administered

peptide, which we believe is activated through the hypothalamus, and

we believe it signals sexual arousal," says Stephen T. Wills,

Palatin’s CFO. "We anticipate the program for males could be approved

in mid 2006, and for females up to a year later."

Palatin has doubled its size in two years. Several months ago the

company consolidated office space at the Carnegie Center with laboratories

in Edison by moving from a total of 16,000 square feet to 28,000 feet

at Cedar Brook Corporate Center. Its 46 employees are working on a

variety of therapies (including a product for infection imaging and

an overall technology to design compounds). The facility can hold

up to 75 people, and Palatin is hiring chemists, biologists, analytical

scientists, quality control specialists, and product developers. In

August it concluded an offering of 2.6 million shares that brought

in $4.2 million.

In the first part of Phase II trials for the treatment of erectile

dysfunction (ED), 24 patients with a mild-to-moderate condition were

able use PT-141 to achieve sufficient rigidity (greater than 60 percent)

to begin sexual intercourse in about 30 minutes. When compared to

a placebo, the PT-141 tripled the duration of erectile activity.

For patients with a more severe form of ED (those who had no response

to visual sex stimulation), the drug increased the erectile activity

by a factor of 12. Phase 2B trials of PT-141 for the treatment of

ED in an at-home setting are expected to start this fall.

"We have had such robust results that we have actually started

a trial with severe dysfunction, people who are not responsive to

Viagra, and are halfway through these trials," says Wills.

How does this drug work? "PT-141 contains a synthetic analog of

a melanocyte-stimulating hormone. Hormones that stimulate melanocyte

also stimulate another receptor that is associated with sexual arousal,"

says Shubh Sharma, chief technical officer. His researchers have determined

that this receptor subtype is specifically involved in controlling

penile erection.

Approximately 30 minutes before intercourse, the patient takes a single

nasal dose of PT-141. Current oral ED therapies require 1-plus hours.

"In addition, the nasal formulation of PT-141 is as convenient

as oral treatments, and more patient friendly than invasive treatments

for ED, such as injections and trans-urethral pellets," says Wills.

Palatin has just announced good news from the Phase 1 clinical trial

of its drug for women. Thirty-two premenopausal women volunteers viewed

sexually stimulating photos and used a nasal spray, either the Palatin

drug or a placebo. For those who used the Palatin spray, genital blood

flow increased. Preclinical animal studies had showed that administering

PT-141 resulted in dramatic increases in female rodents’ solicitations

of their male partners.

"Given that PT-141 acts on the areas of the brain responsible

for sexual arousal, as opposed to the peripheral vasculature, this

observation of increased genital blood flow is especially encouraging,"

says Raymond Rosen, professor of psychiatry and medicine at University

of Medicine and Dentistry New Jersey. "The results of this initial

Phase 1 trial demonstrate that PT-141 can facilitate the initial stages

of physiological sexual arousal in normal women."

Early next year Palatin will begin clinical studies to evaluate PT-141

in women with arousal disorders. The market could be big: According

to an article published in the Journal of the American Medical Association,

nearly FSD affects more than 30 million women in the U.S.

— Barbara Fox