Viteava’s clinical strategy leverages clinical data with green tea extracts in patients where biological responses have been observed. These green tea extracts contain various amounts of EGCG (and other constituents), depending on the source or preparation. Viteava’s drug candidates are designed to improve these treatment regimens and enhance the previously observed biological responses.

We have reviewed clinical data with green tea extracts, together with market and competitive factors. We have considered clinical trial design. Based on our initial analysis, including a recently published clinical investigation, our first proof-of-principle clinical studies may focus on treating women with symptomatic uterine fibroids.

Uterine fibroids are benign hormone-dependent tumors of the uterine wall (also called leiomyoma). They affect up to 80% of women ages 35 to 55 causing multiple clinical complications such as heavy bleeding, pain, urinary incontinence and infertility. In major pharmaceutical markets, over 700,000 women each year have symptoms requiring traditional surgery, including hysterectomy. No drug has been approved for the long-term management of uterine fibroids. This is primarily because of the poor side-effect profile of existing agents. These agents are only used for up to 6 months to manage symptoms and reduce the size of fibroids prior to surgery. There remains an unmet need for an oral therapy which can be safely administered long-term to obviate the need for surgery.

Our drug candidates may also be assessed in treating patients with other premalignant and tumor-related conditions. As examples, green tea extracts have been assessed in the following clinical indications:

There may also be a rationale to study Viteava’s drug candidates in an adjuvant (e.g. to prevent tumor/cancer recurrence following surgery) or consolidation (e.g. to sustain remission following chemotherapy) setting. Initial studies in this vein have been conducted with green tea extracts in breast cancer patients and prostate cancer patients.

And finally, Viteava’s drug candidates may also be developed in combination with other cancer chemotherapeutics to treat more advanced disease. To date, synergies have been observed in cell- based and/or animal models between EGCG and/or our drug candidates with bortezomib, cisplatin, cytarabine, daunorubicin, docetaxel, doxorubicin, erlotinib, etoposide and tamoxifen.