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Lupus Clinical Trials

New Medical Therapies™

Human Papilloma Virus (HPV)

September 20, 2010

Inovio reported positive results from a phase I trial of VGX-3100, a DNA vaccine to treat pre-cancerous cervical dysplasias and cancers caused by human papillomavirus (HPV) types 16 and 18. This US-based, open label, dose escalation study enrolled 18 female subjects previously treated for moderate or severe cervical intraepithelial neoplasia. The subjects received VGX-3100 0.6 mg, 2 mg or 6 mg delivered via electroporation. Each group received the respective dose at day 0, month one and month three. All dose groups developed significant antibody and T-cell immune responses; however the third and final dose group (6 mg) showed the strongest response. This cohort developed significant CTL responses, with average responses of 1362 SFU per million cells after three immunizations. This was a 118% increase compared to the intermediate dose cohort average of 626 SFU per million cells (four responders out of six) and a 174% increase compared to the low dose cohort average of 497 SFU per million cells (four responders out of six). Antibodies were also generated against all four antigens; in the third cohort antibody responses were observed in five of six subjects (83%). There were no vaccine-related serious adverse events.

November 24, 2008

Merck reported positive results from a phase III trial of Gardasil for the prevention of human papillomavirus (HPV) types 6, 11, 16 and 18 in men. This placebo-controlled study enrolled 3,400 heterosexual males and 600 homosexual males, aged 16 to 26 years of age. At the time of vaccination, subjects had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners. Gradasil was 90.4% effective at reducing external genital lesions (three in the vaccine group versus 31 in the placebo group; p-value <0.001). Gardasil was 89.4% effective in preventing genital warts. There were no cases of penile/perineal/perianal intraepithelial neoplasia (PIN) in the vaccine group versus three cases of PIN 1 or PIN 2/3 in the placebo group. There were no cases of penile/perineal/perianal cancer in either vaccine or placebo group. In addition, Gardasil was 85.6% effective at reducing persistent infection (15 cases in the Gardasil group versus 101 cases in the placebo group; p-value <0.001) and was 44.7% effective at reducing "anytime" HPV DNA detection (136 cases in the vaccine group versus 241 cases in the placebo group; p-value <0.001).

March 17, 2008

GlaxoSmithKline reported positive long-term data for Cervarix, a vaccine for the treatment of human papilloma virus. Results are from an extended follow-up analysis of women who participated in an initial efficacy study. This initial double-blind, controlled trial enrolled one thousand one hundred and thirteen women, aged fifteen to twenty five years, in Brazil, Canada and the United States. The subjects were randomized to receive three doses of Cervarix, formulated with the AS04 adjuvant system, or three doses of placebo on a zero, one and six month schedule. Over six and a half years, Cervarix showed 100% efficacy in preventing precancerous lesions due to cancer-causing virus types 16 and 18. An efficacy rate of 78% was observed in preventing infection caused by virus type 45 and 60% efficacy was observed in preventing infection caused by virus type 31. Cervarix was determined to have a good overall safety profile over six and a half years, with no significant differences between the study groups. A BLA is currently under review by the FDA.

April 9, 2007

Helix BioPharmaissued positive results from a phase II trial of Topical Interferon Alpha-2b for the treatment ofhuman papilloma virus (HPV). This trial enrolled 41 women with HPV-inducedlow-grade squamous intraepithelial lesions (LSIL) of the cervix, in Germany.The subjects received Topical Interferon Alpha-2b, self-administeredintravaginally three times per week for a period of 6 weeks, or placebo. Theprimary endpoint was Pap-response rate, defined as the proportion of subjectswith resolution of their abnormal Pap smear LSIL cytology to normal during the12 week study duration. Following treatment, 46.7% of the treated women hadtheir pap smears revert back to normal compared to 15. 8% of the women onplacebo. Treatment was well tolerated, with no significant local reactions ordrug-related serious adverse events. Based on the results, Helix plans toadvance the development of Topical Interferon Alpha-2b.

June 19, 2006

Ambrilia Biopharma has reported positive results of a phase Ia trial of PPL-100, their investigational protease inhibitor (PI) for the treatment of HIV/AIDS. Results from the study yielded positive safety and tolerability profiles, with no incidence of serious adverse events and an overall adverse event profile including only mild (Grade 1) events. Preliminary pharmacokinetic data yielded an absorption and elimination profile supportive of once-daily dosing utilizing an un-boosted regimen in both PI-naïve and PI-experienced patients infected with drug resistant HIV strains containing highly prevalent mutations. This single-dose-escalation study enrolled 64 healthy male volunteers across 7 dosing cohorts: five 8-patient cohorts received single doses of the drug (300 mg, 600 mg, 1200 mg, 1800 mg and 2400 mg; n=6 per dose) or placebo (n=2 per dose); one cohort investigated the effects of combining the 600 mg and 1200 mg dose with a light meal; and one cohort combined the 600 mg dose with a light meal and low dose ritonavir (100 mg). Based on these results, the company announced plans to initiate a phase Ib trial in summer 2006, with results expected before year's end.

Nventa Biopharmaceuticals issued positive results of a phase I/II trial of HspE7, their investigational vaccine for the treatment of human papillomavirus (HPV) -related high-grade anal intraepithelial neoplasia (AIN) in HIV positive patients. Trial data indicated that 33% of subjects (n=5/15) regressed to low-grade or no significant dysplasia at 48 weeks post-treatment; 3 of these subjects also became HPV negative, vs. none of the patients not responding to treatment (p=0.02). This study enrolled 15 subjects under the direction of the AIDS Malignancy Consortium at the University of California in San Francisco. Subjects received one of three doses of the drug at 4 week intervals, with disease follow-up at 8, 12, 24 and 48 weeks. The company announced plans to begin trials of a more potent formulation of the vaccine within the next year.

May 1, 2006

Biolex and OctoPlus have issued positive results of a phase I trial of Locteron, for the treatment of chronic hepatitis C infections, at the European Association for the Study of Liver Disease meeting in Vienna. This randomized, double-blinded, placebo-controlled study enrolled 27 healthy volunteers in The Netherlands, who received three escalating doses of Locteron or the approved pegylated interferon drug PEG-INTRON. Trial data yielded a positive safety and tolerability profile, with reductions in frequency and severity of flu-like symptoms following dosing relative to the approved treatment. Pharmacokinetic data were supportive of dosing every two weeks, and administration of the drug yielded a linear release profile, without a front-end "burst effect." Changes in biomarkers associated with interferon activity were also noted, at levels equal or greater to those noted with PEG-INTRON.

Transgene issued positive results of a phase II trial of TG4001, for the treatment of high-grade cervical intraepithelial neoplasia (CIN2/3) associated with HPV-16 infections, at the Eurogin 2006 Congress in Paris. 6-month data yielded preliminary evidence of efficacy, with 55% of evaluable subjects (n=10/18) achieving normal colposcopy, 50% (n=9/18) yielding no CIN2/3, and 50% (n=9/18) achieving a complete elimination of HPV16 E6/E7 mRNA. No serious adverse events were associated with treatment. This open-label study enrolled 21 CIN2/3 patients across 9 sites in France, who received 3 subcutaneous injections of the vaccine (5.107 pfu).

October 10, 2005

Merck reported positive results of their phase III "FUTURE II" trial of Gardasil, their quadrivalent human papillomavirus (HPV) vaccine for the prevention of HPV-associated cervical cancers, at the Infectious Diseases Society of America Annual Meeting. Trial data have yielded evidence of efficacy, with the vaccine preventing 100% of cases of high-grade cervical intraepithelial neoplasia and non-invasive cervical cancers associated with HPV strains 16 and 18, compared to 21 cases in the placebo group (p<0.001). Furthermore, all subjects receiving the vaccine remained free of detectable HPV 16/18 infections through 7 months. Secondary efficacy data, which considered a broader patient cohort that included potential protocol violators and patients who may have become infected with HPV during the vaccine course, yielded a 97% reduction in lesion risk, with 1 case in the treatment group vs. 36 for placebo. The most common drug- related adverse event was injection site discomfort. This prospective, randomized, double-blind, placebo-controlled study enrolled 12,167 women across 90 sites in 13 countries, who received three doses of Gardasil (n=6082) or placebo (n=6075) over 6 months, and who were then followed for an average of 2 years. Results of this trial were to be included in the BLA for the drug, scheduled to be filed in Q4 2005.

Vertex Pharmaceuticals has issued positive results of a clinical trial of their hepatitis C virus (HCV) protease inhibitor VX-950, for the treatment of chronic HCV infections. These data were presented at the 12th International Symposium on Hepatitis C and Related Viruses in Montreal. Results from the study indicated that the drug reduced median serum alanine aminotransferase (ALT) levels after 14 days of treatment, with decreases of 25-32 U/L for all treatment arms (n=18), compared to a decrease of 8 U/L for placebo (n=6). These reductions corresponded to 83% of subjects with elevated ALT levels at baseline achieving normalization by day 14, compared to 0% for placebo. These reductions may indicate reductions in HCV-related liver damage. This placebo-controlled study enrolled 24 subjects, who received one of three doses of the drug or placebo for 14 days. Based on these results, Vertex re-affirmed its plans to initiate a phase Ib trial of the drug in Europe and to file an IND for the drug in the US in Q4 2005, to support initiation of phase II trials before year's end.

March 22, 2004

Transgene reported results from a phase II trial investigating MVA-HPV-IL2, a vaccine for human papilloma virus (HPV)-related diseases. Data showed that partial clinical and histological responses were observed in five subjects treated with a high dose. The study enrolled 28 subjects with High-Grade Cervical Intraepithelial Neoplasia CIN 2/3 in France. No indication of CIN regression was observed in the 12 subjects treated with the low dose. Subjects were given different doses (5.105 pfu and 5.107 pfu) administered sub-cutaneously. Subjects were treated with MVA-HPV-IL2 on days 1, 8 and 15, with conisation performed at week six. The primary endpoint was, demonstrated clinical and histological efficacy measured by the elimination of the CIN lesions at six weeks. MVA-HPV-IL2 was simultaneously tested in 20 subjects with vulvar intra-epithelial neoplasia (VIN3).

October 28, 2002

Lycos reported positive preliminary results of a phase IIb trial investigating ZYC101a in women with high-grade cervical dysplasia, caused by the human papilloma virus (HPV). The randomized, double blinded, placebo-controlled study of 161 women was conducted in 17 centers across the U.S. and in Europe. In a preselected cohort of younger subjects, high-grade cervical dysplasia was resolved in 70% treated with ZYC101a compared to only 23% of subjects treated with placebo. In the total population, high-grade cervical dysplasia was resolved in 43% of subjects treated with ZYC101a compared to 27% of subjects treated with placebo. The drug was shown to be safe and well tolerated.

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