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Women's Health

March 17, 2014

Palatin Technologies issued results of a phase IIb trial of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD), both forms of female sexual dysfunction (FSD). Approximately 400 premenopausal women diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both were enrolled in the multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial. Patients were treated for 16 weeks and randomized to one of four double-blind treatment groups receiving placebo or subcutaneous (SC) bremelanotide doses of 0.75mg, 1.25mg or 1.75mg. Responder analyses showed bremelanotide had a statistically significant increase in the percentage of women whose total score on the Female Sexual Function Index (FSFI) improved: 69% for 1.75mg v. 46% for placebo (p<0.05). A significantly higher percentage of women on bremelanotide v. placebo achieved at least one satisfying sexual event (SSE): 55% for 1.75mg v. 37% for placebo (p<0.05). As-needed administration of bremelanotide 1.75mg v. placebo also demonstrated episodic increases in levels of desire (0.4 v. 0.0, respectively) and in the women’s satisfaction with their levels of desire (0.6 v. 0.1, respectively). Palatin anticipates commencing enrolling patients in phase III clinical trials in the second half of this year.

November 29, 2010

Aeterna Zentaris released positive results from a phase II trial of AEZS-108 for the treatment of endometrial cancer. This trial enrolled 44 subjects with histologically confirmed LHRH-R positive advanced or recurrent endometrial cancer. AEZS-108 was administered at a recommended dose of 267 mg/m2 by intravenous infusion over two hours, with retreatment every three weeks, for up to six courses. The primary endpoint was response rate per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Of 43 subjects treated with AEZS-108, 39 were evaluable for efficacy. Responses confirmed included two subjects with complete response (CR; 5.1%), ten subjects with partial response (PR; 25.6%), and 17 with stable disease (SD; 43.6%). Based on those data, the Overall Response Rate was 30.8 % and the Clinical Benefit Rate was 74.4%. The treatment was well tolerated.

November 1, 2010

Ariad Pharmaceuticals and Merck reported positive interim results from a phase II trial of oral ridaforolimus for endometrial cancer. This randomized, open-label, active-control multicenter study has enrolled 114 female subjects with metastatic or recurrent endometrial cancer. The subjects received oral ridaforolimus, oral progestin or chemotherapy. The primary endpoint is progression free survival (PFS) determined using RECIST criteria, based on radiologic studies conducted every two months. The interim analysis demonstrated a significant improvement in PFS, with a statistically significant 1.7 month difference in median PFS (ridaforolimus, 3.6 months; standard of care, 1.9 months; p≡0.007). Based on these data, further enrollment was stopped and the surviving patients will continue to be followed.

July 26, 2010

Results were reported from a phase IIb trial evaluating Gileads tenofovir gel as a microbicide against HIV and genital herpes. This trial, CAPRISA 004 (Centre for the AIDS Programme of Research in South Africa), enrolled 889 South African women who were 18 to 40 years of age, HIV-negative, sexually active, and at high risk of becoming infected with HIV. The subjects were asked to vaginally insert a first dose of tenofovir gel no more than 12 hours before having sex and to insert a second dose no more than 12 hours after having sex. No more than two doses of gel were used in a 24-hour period. The treatment period was 12 to 18 months. The gel was found to be 39% effective in reducing the risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections. The efficacy of tenofovir was greater with increased usage. The women who used the gel more than 80% of the time had a 54% reduction in HIV infections, whereas those who used the gel less than half the time had a 28% reduction in HIV infections.

February 16, 2009

Indevus reported positive results from a phase II/IIb trial of PRO2000 for the prevention of HIV. This randomized, placebo-controlled, double blind study, dubbed HPTN 035, enrolled approximately 3,100 HIV-uninfected women across sites in Zimbabwe, Malawi, Zambia, South Africa, and the USA. The four-arm trial compared PRO2000, BufferGel (ReProtect), a placebo gel, and no gel. Women enrolled in the three gel arms were to apply the product vaginally up to one hour before each act of sexual intercourse. They were subsequently followed for 12-30 months. The primary endpoint was efficacy in preventing of HIV transmission. Additional endpoints included the prevention of bacterial vaginosis, herpes virus infection, and other sexually transmitted diseases. Of the 3,100 enrolled subjects, 194 new HIV infections occurred over the course of the trial. Of these, 36 occurred in the PRO 2000 arm, 54 in the BufferGel arm, 51 in the placebo arm, and 53 in the no-gel arm, demonstrating that PRO2000 was at least 30% more effective than any other arm in preventing HIV. PRO2000 did not show protection against any other sexually transmitted infection. The treatment was well tolerated.

August 27, 2007

Medicinova issued positive results from a phase Ib trial of MN-221 for the treatment of pre-term labor. This trial enrolled 10 healthy, pregnant subjects who were not in labor. The subjects received a single-dose intravenous infusion regimen of MN-221, consisting of two consecutive rounds of a 15-minute priming and a 105-minute maintenance infusion to deliver 294 micrograms of MN-221 over four hours. The primary endpoints included pharmacokinetics, safety and tolerability. Treatment was safe and well tolerated, with no reported serious adverse events. In addition, target plasma concentrations were achieved with an intravenous priming followed by maintenance infusion dosing paradigm. Based on the results, Medicinova plans to move forward with development.

July 30, 2007

Alliance reported positive results from a phase III trial of Isprelor for the induction of labor. This trial enrolled 600 women who received Isprelor (25 mg) or dinoprostone (standard of care). The study met the primary endpoint of non-inferiority. The two treatments were similarly efficacious, with no statistical difference between Isprelor and dinoprostone in the ability to produce a vaginal delivery within 24 hours of commencing treatment. No unexpected adverse events occurred and Isprelor was shown to be no more likely than dinoprostone to cause hyperstimulation of the uterus. Based on the results, Alliance planned to file for European approval in the second half of 2008.

March 28, 2005

Stressgen Biotechnologies reported positive results of a phase II trial of HspE7, for the treatment of high-grade cervical dysplasia. These results were announced at the Society of Gynecologic Oncologists Annual Meeting on Women's Cancer. Data indicated that the drug produced a complete pathologic response in 32% of patients (n=10), a partial response of greater-than-50% lesion regression in 39% of patients (n=12), and stable disease in 29% of patients (n=9). No patients receiving the drug experienced progressive disease. The drug was also observed to be well tolerated, with no serious adverse events and injection site reactions noted as the most frequent overall adverse event. This open-label study enrolled 31 women with confirmed cervical dysplasia, who received three subcutaneous injections of 500 mcg HspE7 over sixty-days, prior to all subjects undergoing a Loop Electrocautery Excision Procedure. The company announced that, based on these results, they planned to initiate additional trials of the drug to investigate whether complete pharmacologic response will allow patients to avoid surgical excision.

August 19, 2002

Results of two international studies involving over 700 subjects indicated that imiquimod cream 5% is effective in treating women with external genital warts. 75% of subjects treated with imiquimod experienced complete clearance of their warts. Although 15% of subjects had warts return six months after finishing treatment, re-application of the product for an additional 16 weeks cleared the warts in 75% of those subjects. Imiquimod is manufactured by 3M Pharmaceuticals.