Our initial goal is to get FDA approval of Picoplatin and make it a (or the) preferred platinum-based drug in cancer treatment and to demonstrate the predictive capability of our genomic technology.
This will create a foundation of further development of the company, which is planned to be centered around rescue and repositioning of in-licensed underappreciated clinical assets, supplemented with our genomic technology.
The key elements of our clinical strategy in are:
• Complete two Phase II clinical trials for Picoplatin for the purpose of defining and validating
genomic signatures of the Picoplatin response in patients with (a) squamous cell carcinoma of
head and neck (or SCCHN) as well as (b) metastatic colorectal cancer (CRC). (CRC is the third
leading cause of cancer death in both men and women in the U.S. and the second leading cause
of cancer death of men and women combined).
• Following the completion of our Phase II trials, we plan to conduct a Phase III clinical trial for
either or both ijndications which will utilize these genomic classifiers to increase the patient
response rate to Picoplatin.
Our midterm business strategy include:
• Submission of application for registration of our drug to the Ministry of Health of the Russian
Federation for the right to market and sell Picoplatin for SCLC in the Russian Federation.
• Seek a strategic partnership with a European partner to obtain European Union approval of
Picoplatin for SCLC. (The European Commission designated Picoplatin as an orphan medicinal
product for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of
marketing exclusivity in the European Union)
• Commercially Launch Picoplatin in the U.S. Although we may decide to utilize a small specialty
sales strategy for targeting oncologists to launch Picoplatin if it is approved in the U.S., our
primary focus will be dedicated to entering into a partnership with a pharmaceutical company
with an established sales force for the full commercialization of Picoplatin and retaining a
meaningful royalty percentage based upon U.S. sales
• Pursue opportunities to develop and commercialize Picoplatin in foreign markets. As we engage
in clinical trials for Picoplatin in the U.S., we will also seek to enter into development and
commercialization partnerships with pharmaceutical companies in foreign countries.
• Leverage our genomic technology by acquiring rights to other compounds. We will seek to in-
license other drug compounds that we believe would be well-suited for our genomic technology.
We believe that, once proved by our Picoplatin clinical trials, our genomics program has the
potential to become a platform technology that could be used with other drug compounds