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Lupus Clinical Trials

New Medical Therapies™

Hot Flash

February 18, 2008

Bentley issued positive preliminary results from a phase II trial of Nasulin for the treatment of type II diabetes. This open label, randomized, parallel group study enrolled eighty subjects in India. The trial was designed to compare Nasulin as add-on to oral anti-diabetic therapy or oral anti-diabetic therapy alone. The subjects self-administered Nasulin spray three times per day for twelve weeks. The primary endpoints were reduction of Post Prandial Blood Sugar (PPBS) by 20mg/dl from the baseline value and reduction of glycosylated hemoglobin (HbA1c) by 0.7% from the baseline value. Initial results revealed that the subjects receiving Nasulin reached their primary endpoint for PPBS after two months, with an average decline of 49mg/dl. However, PPBS values increased in month three, apparently to levels above the primary endpoint. HbA1c levels also declined by an average of 0.7 or more after two months. However, HbA1c levels also increased in month three, again to levels above the primary endpoint. Nasulin was well tolerated, with no reported serious adverse events, no overall weight gain over the three month interval and no indication of severe hypoglycemia. Based on the results, Bentley plans to move forward with the development of Nasulin.

Depomed released positive results from a phase II trial of Gabapentin GR for the treatment of menopausal hot flashes. This thirteen week, double-blind, placebo-controlled, multi-center trial enrolled one hundred and twenty four menopausal women with recurrent, moderate to severe hot flashes, in the United States. The subjects were placed into three active treatment arms: each arm remained on a stable Gabapentin GR dose for five weeks at an initial dose (600mg once daily; 1200mg in divided 600mg doses; or 1200mg once daily), followed by five weeks on a stable, incrementally higher dose (1800mg in divided 600mg and 1200mg doses; 2400mg in divided 600 and 1800mg doses; and 3000mg in divided 1200mg and 1800mg doses). Each stable dosing regimen was preceded by a one-week titration period. The primary endpoint was a reduction in the frequency and severity of hot flashes compared to baseline. Data revealed statistically significant results over placebo from baseline to the end of the study in the 1800mg and 2400mg treatment groups. In the 1800mg treatment group, the mean number of moderate to severe hot flashes was reduced from 10.1 at baseline to 2.7 at endpoint (p=0.016), with similar results in the 2400mg treatment groups, compared to an endpoint value of 5.1 for the placebo group. Treatment was well tolerated. Based on the results, Depomed plans to move forward with phase III development.

June 18, 2007

Bionovo reported positive results from a phase II trial of MF101 for the treatment of hot flashes associated with menopause. This double-blind, placebo- controlled, randomized trial enrolled 217 women in the US. Subjects received MF101 (5 grams/day), MF101 (10 grams/day), or placebo for twelve weeks. The primary endpoints were to assess the safety, tolerability and the potential efficacy of two doses of MF101 to reduce the frequency and severity of hot flashes. In terms of the number of hot flashes per day, MF101 (5 gm) was more effective than placebo at 12 weeks but did not reach statistical significance (p=0.06). MF101 (10 gm) did reach significance compared to placebo (p=0.05). Both doses combined were superior to placebo (p=0.04). In terms of reducing the severity of hot flashes, MF101 showed a trend towards improvement over placebo for both the 5 gm dose (p=0.12) and the 10 gm dose (p=0.1) and was superior to placebo with both doses combined (p=0.08). The percent of women reporting greater than 50% reduction in all hot flashes was statistically significantly higher in the MF101 high dose group compared to placebo (p=0.03) and in both doses of MF101 combined compared to placebo (p=0.05). Based on the results, Bionovo plans to advance MF101 into future trials.

Indevus announced positive results from a phase III trial of Nebido for the treatment of male hypogonadism. This randomized, open-label study enrolled 237 subjects who received Nebido dosed as either 1000 mg every 12 weeks or as 750 mg every 12 weeks, both via intramuscular injection. The endpoint was responder analysis, defined as a subject who, during a steady state, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). This endpoint was met if 75% of the subjects achieved Cavg levels within this range. Of the subjects in the 1000 mg arm receiving their fourth injection, 94% a Cavg level within the normal range over the course of the 12 week injection period. In addition, no subjects in the 1000 mg arm exceeded a testosterone concentration of 2500 ng/dL. Of the subjects in the 750 mg arm receiving their fourth injection, 86% had a Cavg within the normal range. No subjects in the 750 mg arm exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL. Based on the results, Indevus plans to submit a NDA to the FDA later in 2007.

May 12, 2003

BioSante Pharmaceuticals reported positive results from a phase II/III trial investigating Bio-E-Gel (estradiol), a topical gel for the treatment of hot flushes in menopausal women. Results demonstrated that Bio-E-Gel effectively reduced the severity and frequency of moderate-to-severe hot flushes, according to FDA guidance for development of estrogen products. In addition, data showed that Bio-E-Gel delivered estradiol evenly over time without significant fluctuations in blood levels, such as those typically associated with hormone tablets. The randomized, double blind, placebo-controlled study of 161 symptomatic menopausal women was conducted in the U.S. and Canada. The objective of the trial was to identify an effective dose of Bio-E-Gel to study in Phase III development. Bio-E-Gel was applied daily to the same site with minimal skin irritation observed. Of the 161 women in the trial, only four experienced a brief episode of mild irritation.

April 1, 2002

Preliminary results of a multi-center, phase III trial of Novavox's Estrasorb (estradiol topical emulsion) indicated that subjects receiving Estrasorb experienced a statistically significant reduction in hot flashes, compared to those receiving placebo. In the randomized, double-blind, placebo-controlled trial, 200 menopausal women received either placebo or a 3-gram dose of Estrasorb (7.5 mg estradiol) over a 13-week treatment period. Those receiving Estrasorb demonstrated an 85 % reduction in hot-flashes, the primary endpoint. Approximately half of the Estrasorb-treated subjects reported complete cessation of hot flashes during a seven day period by week 10, compared to 10% of placebo-treated subjects who experienced this cessation.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.