Cytodyn Inc (CYDY)

[trding]

I don't remember seeing those results in detail before: 12 enrolled, 2 discontinued lost to follow-up and dual/mixed tropism at screening, 8 completed reported VL of target not detected at week 25-- 7 of which rolled over, 2 ongoing.

Background: In patients infected exclusively with CCR5-tropic HIV-1, PRO 140 (humanized CCR5 mAb) demonstrated potent antiviral activity of ≥1.65 log10 mean viral load reduction as a weekly subcutaneous injection (SC).

Methods: PRO 140_CD02 is ongoing two part (Part 1 and 2) study with a target enrollment of 30 treatment-experienced CCR5-tropic HIV-infected patients who demonstrate evidence of HIV-1 replication despite ongoing combination antiretroviral therapy (cART) with documented resistance to multiple antiretroviral (ARV) drug classes.

Part 1 is a 1-week randomized, double-blind, placebo-controlled period consisting of two treatment arms (PRO 140 350 mg or placebo) along with existing cART (failing regimen).

Part 2 is a 24-week single-arm, open-label treatment period with all patients receiving PRO 140 350 mg SC weekly along with optimized background therapy (OBT), which immediately follows Part 1.


Results: Twelve patients were enrolled to date with a mean age of 55 yrs, 91.6% male, and 41.6% non-white. Mean duration of HIV infection was 21.6 yrs and 66.6% were treated with ≥10 previous ARVs. Mean baseline viral load (VL) was >4.2log10 (50% BL VL ≥10,000 copies/mL) and mean baseline CD4+ T count was 323.4 cells/µL (33.3% <200 cells/µL).

The results for the primary efficacy endpoint i.e., the proportion of patients with ≥0.5 log10 reduction in HIV-1 RNA VL from baseline at the end of the 1-week double-blind treatment period, is not yet analyzed as study enrollment is ongoing and data is still blinded. Eight patients completed the study, 2 are ongoing, and 2 had discontinued the study early for reasons of lost to follow-up and dual/mixed tropism at screening. All 8 completed patients reported VL of target not detected at week 25. Investigators from several sites have requested continued access to PRO 140 in order for patients to continue deriving clinical benefit and maintain HIV-1 viral suppression after end of treatment in CD02 study. Seven patients have entered the rollover study after completing 25-week participation in CD02 study. No PRO 140-related SAEs or discontinuations were reported to date. The results of primary endpoint analysis and additional lab data such as PhenoSense entry assay, serum conc. of PRO 140 and failing cART/OBT, and anti-PRO 140 antibodies expected to be available at the time of presentation.

Conclusions: Interim results of this Phase 2b/3 study showed that PRO 140 in combination with OBT demonstrated significant VL reductions in HIV-1 infected patients with resistance to multiple ARV drug classes and was well tolerated.

http://www.abstractsonline.com/pp8/#!/4358/presentation/6520