Approximately 20 clinical trials undertaken by previous investigators studying approximately
1,100 patients have established the safety of the Picoplatin compound used as a mono-therapy
as well as in combinations, and investigated efficacy in Phase II and III trials
In a controlled study with 101 colorectal cancer (CRC) patients, Picoplatin demonstrated a 67% reduction in neuropathy compared to Oxaliplatin, the current standard of care, and the Picoplatin group experienced no severe neuropathy (versus 12% in the control group).
A Phase III study of small cell lung cancer (SCLC) patients achieved a secondary endpoint of improvement in progression fee survival, but failed to reach a statistical significance in overall survival (the primary endpoint of the trial).
Our goal is to correct the challenges faced by previous Picoplatin clinical trials using the the predictive capability of our genomic technology.
As we analyzed the data from the previous trials retrospectively implementing our genomic predictors, both clinically and statistically significant
improvements were observed for patients with resistant- and early-relapsing disease, a group that has no approved treatment.
In summary, Picoplatin has demonstrated efficacy potential in multiple cancer types. Extensive existing clinical data shows a clear path towards
potential regulatory approval -- better safety profile and drug’s ability to overcome platinum resistance, especially when supplemented with
our genomic technology for patient selection.
1. Hamilton G. Picoplatin pharmacokinetics and chemotherapy of non-small cell lung cancer.
Expert Opin Drug Metab Toxicol. 2013 Oct;9(10):1381-90.
2. Eckardt JR, Bentsion DL, Lipatov ON, Polyakov IS, Mackintosh FR, Karlin DA, Baker GS,
Breitz HB. Phase II study of picoplatin as second-line therapy for patients with small-cell
lung cancer. J Clin Oncol. 2009 Apr 20;27(12):2046-51.
3. Ciuleanu, T. Samarzjia, M. Demidchik, Y. Beliakouski, V. Rancic, M. Bentsion, D. L. Orlov,
S. V. Schaeffier, B. A. De Jager, R. L. Breitz, H. B. andomized phase III study (SPEAR)
of picoplatin plus best supportive care (BSC) or , V28 BSC alone in patients (pts) with
SCLC refractory or progressive within 6 months after first-line platinum-based chemotherapy.
Journal of Clinical Oncology, 2010, v28 (15)