BP-C1

Is based on a combination of BP-Cx-1 and platinum.  It contains approximately 100 times less platinum than ordinary doses of Cisplatin used in chemotherapeutical drugs, resulting in a much enhanced safety profile.  At the same time, clinical efficacy is maintained or improved due to the carrier effect of the polymer.  

When compared to other known platinum compounds, the ability of BP-C1 to kill cancer cells is comparable to that of the approved drug Cisplatin and much better than Carboplatin (Figure 1, A). In addition it acts through the same cellular pathways as Cisplatin (Figure 1, B).

Although BP-C1 acts like Cisplatin on the cellular level, it has a much improved safety profile in animals as well as human beings. In animal models of Breast Cancer, BP-C1 has the same efficacy in reducing tumor growth as Cisplatin (Figure 2, A). However, at the same doses Cisplatin killed the mice, whereas BP-C1 did not (Figure 2, B)

Toxicology studies have likewise showed that BP-C1 is extremely safe even at 200-fold the clinical dose. Combining much reduced toxicity of BP-C1 compared to traditional platinum compounds with the much lower clinical dose, this results in an unprecedented human safety margin of >1000-fold.

Clinical experience exists from both compassionate use in a number of difference cancers (150 pts) and a Phase I/II trial in advanced metastatic breast cancer (17 patients).  Very good efficacy data, with response rates of >50%, and only mild side effects were observed, and patients experienced improved general well being.

The Phase I dose-escalation trial was completed in January 2011, and will be followed by Phase II randomized placebo controlled efficacy trials in advanced metastatic breast cancer. In parallel, Company is planning the development of BP-C1 for Pancreas, Ovarian and Prostate cancer, palliative therapy in terminal cancer patients, and for veterinary use in breast cancer of cats and dogs.