a P2? what will happen to the sp then if they decide to try a p2 for prostate cancer? this will cost around 4 million to run. i know whatever drug for animals will be cheaper to run. or did endo prevented it in whatever deal bioniche signed? why will they have an AGM? Bail do you plan for it? Background A cell wall-DNA complex prepared from Mycobacteria phlei wherein mycobacterial DNA is preserved to the cell wall (MCC) has been shown to exert an anticancer activity. In this study, we report the activity of MCC suspension formulated in hyaluronic acid (HA) against human prostate cancer cell lines, its toxicological profile following intraprostatic administration in dogs, and the results from a Phase-I study in patients with localized prostate cancer who received intraprostatic injection of MCC/HA before their scheduled prostatectomy. Methods The in vitro anticancer activity of MCC/HA against human prostate cancer cell lines LNCaP and PC-3 was determined using inhibition of proliferation assays. Toxicological profile was assessed following MCC/HA (0.001-1mg MCC/HA) intraprostatic administration in male beagle dogs and reactivity determined after 21 days. Twelve patients with clinical localized prostate cancer (T1c, T2a-2c) took part in the phase-I trial and received a single dose of MCC/HA (0.1, 0.2, 0.4 or 0.8mg) by transurethral injection under transrectal ultrasound. Safety was evaluated by adverse events (AEs) and reactivity in the prostate was determined by histological analysis. Results In vitro, MCC interacted synergistically with HA to inhibit the proliferation of human prostate cancer cell lines. MCC/HA can be injected safely into male beagle dogs prostate at doses up to 1mg (No Observable Adverse Effect Level (NOAEL)), which is 4.7 times higher than the dose given to patients, based on a surface area conversion. MCC/HA was well tolerated by all patients; the most frequent drug related AEs included chills/malaise (N=5) and nausea (N=2). Histological examination of the prostate revealed a predominantly lymphocytic infiltration in the prostate and early granuloma formation in 50% of the patients. Conclusions MCC/HA shows anticancer activity against prostate cancer cell lines and an excellent toxicology profile in dogs. Drug related AEs in patients were limited to mild flu-like symptoms, consistent with the immune stimulatory activity of MCC. A Phase 2a study to confirm the safety and efficacy of MCC is planned.
https://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=37&abstractID=20349