Replies to post #6784 on Todos Med Ltd (TOMDF)

[GreeseMonkey]

So you're saying the Tollovir group did not receive Remdesivir? That's not what was published in the press release yesterday, not what was discussed in the presentation, and I don't believe that's what Gerald is trying to convey on Twitter. Both Tollovir and Placebo groups received SOC (Remdesivir).

From the press release:

Study design:

Study NLC-V-01 was a double blinded randomized placebo-controlled study designed to evaluate the safety and efficacy of NLC-V (Tollovir™) in adult patients with a confirmed diagnosis of SARS-CoV-2 infection, who are hospitalized due to the infection. Approximately 78 patients were set to be randomized using a 1:1 ratio (approximately 39 per arm) and stratified by weight group (<70 kg, 70-100kg, and >100kg) to receive Tollovir or placebo, in addition to standard of care. Patients who need mechanical ventilation received the randomized treatment using Liquid Syrup. The Company paused enrollment of the NLC-V-01 clinical trial after enrollment of 31 patients to perform an interim-analysis to evaluate the safety and efficacy profile of Tollovir.

(a) Part 1: Tollovir Clinical Trial Part 1 (TCTP1) (N=11): Tollovir formulation 1 (TLVR1) + SOC (N=6) vs. Placebo + SOC (N=5). This part of the study enrolled patients from December 2020 through February 2021 primarily during the Third COVID Wave (Alpha and Beta variants).

(b) Part 2: Tollovir Clinical Trial Part 2 (TCTP2) (N=20): Tollovir formulation 2 (TLVR2) + SOC (N=11) vs. Placebo + SOC (N=9). This part of the study enrolled patients from May 2021 through November 2021 primarily during the Fourth COVID Wave (Delta variant).

Part 2 Conclusion:

The data from part 2 indicates that patients exposed to Tollovir (TLVR2) + SOC showed better overall clinical improvement (as measured by the endpoints described in Table 1 above) as compared to patients who were treated with placebo + SOC.

Clearly the Standard of Care (SOC) Remdesivir was administered to both Tollovir and placebo patients. Otherwise, you couldn't conclude anything based on Tollovir because the improvements might have been the result of lack of Remdesivir in the patients receiving Tollovir.