Efficacy of a Novel Antibody TLR3 Modulator in the Self-Treatment of Common Cold: The ESTUAR Trial

Context: Since the discovery of toll-like receptor 3 (TLR3), no specific tools have been developed to modulate its activity in upper respiratory tract viral infections (URTIs). ContafluTM (antibodies to TLR3 cytoplasmic fragment) is the first specific TLR3 modulator that showed efficacy in a mouse model of influenza. Objective: To evaluate the efficacy of Contaflu in URTI. Methods: A double-blind randomized placebo-controlled trial in adults with self-reported URTI (the ESTUAR trial) was conducted in 2012/2013 in Belgium. Adult outpatients started a 7-day treatment course with oral tablets of Contaflu or placebo within 36 h after onset of at least one of 4 typical symptoms of URTI. Patients were examined twice by their general practitioners, on days 2-3 and 10-14 after start of treatment. The primary endpoint was the overall severity of URTI calculated as the sum of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) scores over the follow-up. Independent Student’s t test was used to compare the disease severity between groups. Results: A total of 243 patients were enrolled by 32 investigators (121 Contaflu, 122 placebo);92% of cases matched ICD codes J00 or J06. Most patients had very mild (41.8%) or mild (18.2%) URTI symptoms. In the ITT cohort, neither primary nor secondary outcome measures (duration of URTI, day-to-day and overall functional impairments) showed statistically significant differences between groups. The rate of adverse events was similar in both groups. In patients with moderate to severe URTI symptoms, Contaflu tended to reduce the overall disease severity, daily symptoms, and to improve the functional state. Due to the small size of the corresponding subgroups, Contaflu efficacy on daily scores was statistically significant (p < 0.05) only 1, 2, and 5 days after start of treatment. Conclusion: Contaflu was ineffective in mild URTI and showed efficacy in moderate to severe URTI cases.

Efficacy of 2LPAPI®, a Micro-Immunotherapy Drug, in Patients with High-Risk Papillomavirus Genital Infection

Human papillomaviruses (HPVs) are well known for being linked to the development of cervical cancers, most of them being caused by the high-risk (HR) oncogenic genotypes, mainly 16 and 18. The efficacy of 2LPAPI® (Labo’Life), a micro-immunotherapy homeopathic drug, has been evaluated in HR-HPV infected women (n = 18), in a private gynecology practice, by comparing them to an untreated control group (n = 18). Patients were 20 to 45 years old and had cytology with Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low grade Superficial Intra Lesions/ Cervical Intraepithelial Neoplasia Grade I (LSIL/CINI). Patients freely chose to be treated with the drug or not. Those deciding not to take the drug remained untreated and were followed as a control group. The drug was taken at the regimen of one capsule per day during 6 months. HR-HPV and cytology were evaluated at 6 and 12 months. After 12 months, HR-HPV was cleared in 78% of the patients taking the drug versus 44% in those not taking it (p = 0.086). In patients over 25 years, HR-HPV clearance in the treated group was significantly higher (81.3%) than in the control group (20%) (p = 0.004). The difference in the regression of the lesion grades almost reached statistical significance (p = 0.053). This follow-up confirms that the micro-immunotherapy drug 2LPAPI® is a safe and effective therapeutic approach to treat HR-HPV cervical lesions in women over 25 years.