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Cold Sores (Herpes Labialis Infections)

December 3, 2007

Transport reported positive results from a phase II trial of SoloVir for the treatment of Herpes labialis. This randomized, double blind, placebo-controlled trial, dubbed TPI-H-221, enrolled two hundred and sixty subjects. The subjects were randomized in a 1:1:1 ratio into one of three treatment groups: treatment with SoloVir gel followed by treatment with placebo gel; treatment with placebo gel followed by treatment with SoloVir gel; or treatment with placebo gel followed by treatment with placebo gel. Treatment was self administered at the first signs and symptoms of a herpatic lesion. The treatment phase ended after eighty subjects in each group had herpatic recurrence and received treatment. Data indicated that treatment at this early stage resulted in a statistically significant effect on the herpetic episode. The SoloVir treated groups showed a 79% increase in aborted lesions over placebo (43% active; 24% placebo; p= 0.03). The subjects receiving SoloVir also experienced a 3.5 day reduction in time to complete healing (p= 0.015). Treatment was well tolerated, with no reported serious adverse events. Based on the results, Transport plans to initiate the next stage of development in 2008.

August 21, 2006

Advancis Pharmaceutical announced positive results from a phase III trial of Amoxicillin, for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections. This double- blind, double-dummy, randomized, parallel-group, 50-center non-inferiority trial enrolled 620 subjects who received a 775 mg Amoxicillin PULSYS tablet, once a day, for 10 days or 250 mg of penicillin, four times a day, for 10 days. The trial met the primary endpoint of statistical non- inferiority with 85% of the PULSYS group achieving bacterial eradication versus 83.4% of the penicillin group. Secondary endpoints met statistical non-inferiority as well in clinical cure rates at the test-of-cure visit and bacterial eradication rates at the late post-therapy visit. Based on these results, Advancis expected to file a NDA for once-daily Amoxicillin by late 2006 or early 2007.

Enzo Biochem issued positive long term results from a phase I trial, initiated in January of 2001, of HGTV43 for the treatment of HIV. This trial enrolled 5 subjects whose stem cells were collected, treated with HGTV43 ex vivo, than re-infused. Long-term safety data were positive with treatment well tolerated and no adverse events reported. Efficacy data collected demonstrated that the engineered stem cells were able to survive long term in vivo and to produce CD4+ cell progeny containing functioning antisense genes. At 12 months post-treatment antisense RNA was present in all five subjects. At 48 months, 4 subjects were available and 3 out of the 4 had antisense RNA present and at month 60 it was present in 1 out of the 3 subjects. In all the subjects tested, anti-HIV-1 antisense RNA was found in the CD34+ bone marrow cells. Enzo is further investigating HGTV43 in phase I/II trials at this time.

Tibotec Pharmaceuticals released positive results from a phase IIb trial of TMC125 for the treatment of HIV. This dose-finding, randomized, partially-blinded study enrolled 199 adult HIV-1 infected subjects who had received prior treatment. Subjects were randomized to receive 400 mg or 800 mg bid of TMC125 (n=159) with a background regimen or best available control regimen (n=40). Safety and tolerability data results demonstrated that the most commonly reported adverse events were diarrhea (22%), pyrexia (20%) and rash (20%) for the TMC125 treated group compared with 15%, 10% and 8%, respectively, for the active control group. Serious adverse events were reported by 27% of the TMC125 group and 18% of the control group. Efficacy data revealed that mean change from baseline in viral load at week 48 for the TMC125 400 mg and 800 mg bid and active control groups was -0.88, -1.01 and -0.14 log10 copies/ml, respectively. In the subjects with NNRTI resistance, those receiving TMC125 400mg or 800mg bid in combination with an optimized background regimen the viral load production was significantly greater than in the active control at 48 weeks, p=0.018 and p=0.002, respectively. Tibotec is conducting phase III trials of TMC125 at this time.

Transport Pharmaceuticals announced positive results from a phase IIb trial of device-enhanced acyclovir for the treatment of herpes labialis. This multi-center, randomized, double blind, placebo-controlled, clinic initiated, proof-of-concept trial enrolled 200 non-immunocompromised subjects, aged 18-75 years, with histories of recurrent cold sore outbreaks (3 or more annually). Safety and tolerability profiles were positive with reported adverse events similar to placebo. Efficacy data demonstrated that the median time to healing for the treatment group was 113 hours versus 148 hours for the placebo group (p= 0.02). The sub-group of participants who were treated at the first visible onset of infection displayed a time to healing of 71 hours versus 120 hours for the placebo group (p= 0.03). Transport plans to conduct additional phase II trials in the next year.

VaxGen reported positive results from a phase I trial of rPA102, the company's anthrax vaccine candidate. This randomized, double-blinded, controlled, multicenter trial enrolled subjects who received rPA102, in varying doses, four weeks apart. It was designed to demonstrate a clear relationship between the rPA102 dose administered and the subsequent immune response. Safety data were positive with no serious adverse events or toxicities reported. Efficacy data were also positive with higher antibody titers seen in subjects who received three injections of the vaccination versus those who received two injections. Based on these results, Vaxgen planned further development of this drug.