PHERIN PHASE 2B CLINICAL TRIALS WITH PH94B

On February 1st, 2008 Pherin Pharmaceuticals announced that it has commenced Phase 2B clinical trials in the US of its proprietary drug PH94B, for the treatment of Social Phobia. PH94B is a low dose (nanogram) pherin compound, delivered intranasally in spray form, which is being developed for the acute treatment in patients with Social Phobia.

The Phase 2B clinical trial is an in-clinic, multi-center, randomized, double-blind, single-administration, placebo-controlled study in approximately 90 Social Phobia patients, using validated psychometric scales. In a similar Phase 2A clinical trial, two doses of PH94B (800 nanogram, and 1600 nanogram) were evaluated against placebo in 40 patients. PH94B signifficantly improved the primary efficacy endpoints (social performance and social interaction anxiety) within 10-minutes post-administration. Secondary efficacy endpoints for the trial included additional anxiety response assessments and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period.

PH94B's mechanism of action is unique. After intranasal spray administration, it acts locally on peripheral receptors from nasal chemosensory neurons that connect to the hypothalamic-limbic areas of the brain. This mechanism of pharmacological action, the rapid onset of effect, and the excellent safety and tolerability profile already demostrated, make PH94B an interesting novel product candidate for the acute treatment of  patients with Social Phobia.

ABOUT PH94B
PH94B is a Pherin’s proprietary compound, a drug belonging to a new class of psychotropic pherines, administered intranasally in nanogram doses. In a Phase 1 dose-escalation clinical trial, doses  ranging from 400 to 10,000 nanograms, were well tolerated and there were no serious adverse events reported.

PRESS RELEASE
Contact: Dr. Louis Monti, Executive Vice President. Phone: (650) 961-2080
Email: lmonti@pherin.com

PHERIN PHARMACEUTICALS REPORTS FAVORABLE PHASE II DATA SHOWING CLINICAL BENEFITS OF NOVEL INTRANASAL MEDICATION PH80 TO TREAT SYMPTOMS OF PREMENSTRUAL SYNDROME (PMS)

• Intranasal aerosol treatment with 800 nanogram PH80 up to four times daily, during the symptomatic days of PMS only, shows significant efficacy, distinct improvement over placebo and symptoms remission in clinically significant PMS

• No adverse events reported, excellent safety and tolerability profile

• Phase III program investigating PH80 now being implemented.

• Approximately 80% of women ages 15 to 44 in the US suffer from symptoms of PMS

Los Altos, California, December 21, 2006
Pherin Pharmaceuticals, Inc. reports that recent clinical trial results from a Phase II study showed that PH80, a novel compound patented by Pherin Pharmaceuticals, administered intranasally in aerosol form demonstrated significant benefits in the treatment of symptoms of PMS. Based on the positive Phase II study results, Pherin Pharmaceuticals is programming a Phase III pivotal study to further evaluate PH80 benefits in patients with PMS.

The multicenter, double blind, placebo-controlled Phase II study involved 60 randomized patients with clinically significant PMS. Patients were randomized into one of two treatment groups: 800 nanogram PH80 up to four times daily, during six consecutive days or placebo. The primary objective of the four-month study was to assess the efficacy of PH80 in treating the symptoms associated with PMS. Results show that during a six day treatment (critical days of PMS only) PH80 administered intranasally up to four times daily improved PMS symptoms significantly better than placebo (P< 0.05).  The medication showed clinical efficacy to reduce premenstrual symptoms in 63% of patients as compared to placebo (44% only) during the treatment phase. Symptom remission was also significantly greater than placebo during the month following treatment with PH80 (P< 0.01).
PMS symptom scores from baseline and after treatment were assessed using validated psychometric scales. Clinical improvement in PMS symptom scores revealed significant change from baseline (P< 0.01) for Irritability and Persistent Anger; Difficulty Concentrating; Depression, Feeling Sad, Down or Blue, and Craving Foods and Increased Appetite and Overeating, among other symptoms. 
Although not statistically significantly different from placebo for four-time daily PH80 (P=0.08) there was also improvement of Cramps with a 30% reduction in mean symptom score with PH80. The proportion of responders, defined as patients with at least 60 % improvement in total PMTS symptom score at the end of each treatment day compared to baseline, showed that 800 nanogram PH80 up to four times daily reached statistical significance (P< 0.05).

“These results are impressive and position PH80 favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require much higher dosing and have concurrent side effects” said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. “We are enthusiastic about sharing these data with companies that express interest in co-developing PH80 with us to advance our development program.”

It is important that intranasal application up to four times-daily of PH80 during the critical days of PMS provides a significant and rapid improvement in symptoms, as well as a carry over symptom remission during the subsequent period. If the magnitude of benefits shown in this Phase II study is confirmed in the larger-scale Phase III study, intranasal PH80 could represent a major improvement in the way PMS will be treated in the future.

There were no adverse events reported associated with PH80 and the medication was well tolerated by the treated patients. We attribute these results to the unique formulation of PH80, which is based on our aerosol drug delivery technology.

Phase II Study Results
The Phase II study was conducted in three centers and in 60 patients to evaluate the effect of PH80 for the acute treatment of symptoms of PMS, as well as its safety and tolerability.

In the placebo-controlled phase, 60 patients were randomized to receive intranasally either 800 nanograms PH80 or placebo up to four times-daily during six consecutive days (critical days of PMS symptoms only). Fifty-six patients completed the study.  The study showed that six-day treatment with intranasal PH80 provides significant improvement in symptom measures and remission in clinical endpoints in patients with PMS. Irritability, Difficulty Concentrating, Depression and Increased Appetite showed improvement significantly better than placebo and Physical Symptoms (Cramps) showed improvement after applying PH80 compared to the effect of placebo.

About PH80 and PMS
PH80 is the first in a new class of Pherin proprietary compounds called pherines that modulate basal forebrain centers acting on peripheral chemosensory receptors in the nasal passages, and has a novel mode of action and a very good safety and tolerability profile different from all currently marketed PMS treatments. PH80 has been developed by and is proprietary to Pherin Pharmaceuticals.

In the US, more than 50 million women 15 to 44 years are estimated to suffer from PMS, which is one of the leading causes of impairment of social activities, family relationships and/or work.

The symptoms of PMS can include irritability, tension, fatigue, lack of energy feeling out of control, aches, mood swings, swelling, bloating, craving foods, cramps, feeling sad and difficulty concentrating. These symptoms can have a significant impact on the patient’s employment, social activities and overall quality of life.

Disclaimer
This release contains certain forward-looking statements regarding to Pherin Pharmaceuticals business that can be identified as “could prevent” or similar expressions, or potential future revenue from PH80. Such forward-looking statements reflect the current views of Pherin Pharmaceuticals regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with PH80 to be materially different from any future results, performance or achievements expressed or implied by such statements.

About Pherin Pharmaceuticals
Pherin Pharmaceuticals has developed a family of leading and innovative proprietary compounds called pherines that bind to peripheral receptors in the nasal passages that affect the hypothalamus and the limbic system and induce proven behavioral, neuropsychiatric and neuroendocrine effects in humans. Among Pherin Pharmaceuticals extensive library of pherines there are molecules being studied for their potential therapeutic application for the treatment of anxiety, depression, body weight management and cognition enhancement.