Curadis is developing a novel transdermally applied medication (4-hydroxytestosterone, CR 1447) for treatment of breast cancer. CR 1447 is a strong binder to the androgen receptor that is expressed in 80-90% of breast cancer tumors. In-vitro results showed anti-proliferative activity of CR 1447 in various breast cancer cell lines (estrogen receptor positive cell lines as well as triple negative cell lines) depending on the presence of the androgen receptor. In the Hershberger assay in castrated rats CR 1447 showed anabolic but negligible androgenic properties. A Phase I study performed by the SAKK (Swiss Group for Clinical Cancer Research), in patients with severe advanced or metastasizing breast cancer was recently completed. It showed an excellent safety, sufficient dose dependent plasma levels after transdermal application and first signs of efficacy. SAKK initiated an oncology Phase II-Study in 14 clinical centers in Switzerland to analyse efficacy Two target groups are included:
Patients with estrogen-receptor positive breast cancer and patients with „Triple Negative Tumors“ (TNBC).
The Studie should be finished withhin two years. Curadis is a virtual company with lean management. All R&D activities are partnered to recognized leaders in the field such as the SAKK (Swiss Group for Clinical Cancer Research), Chiracon, Gesellschaft für Micronisierung and Nextpharma (manufacturing), mode of action studies (academic collaborations, CROs).
CR 1447 has significant potential
CR 1447 has successfully passed Phase I in severe advanced or metastasizing breast cancer patients. An excellent tolerability profile was documented together with sufficient systemic exposure after transdermal delivery achieving significant and dose-dependent plasma levels after transdermal delivery. The recommended dose for the planned Phase II study is 400 mg/day. Very promising are the first signs of efficacy already visible in this early clinical phase. Therefore, continuation of the clinical development of CR 1447 into Phase II is clearly recommended by the clinical investigators
CR 1447 showed significant in vitro activity in prostate cancer cell lines and synergy to androgen inhibiting principles like Abiraterone, Bicalutamide and Enzalutamide
90% of ovarian cancers express androgen receptor; androgens are linked to ovarian cancer and prognosis.
2009 – 2014
In vitro and in vivo studies confirmed the novel mode of action of CR 1447 with high potential in breast and prostate cancer. Novel IP was generated, a GMP process was set up for the active pharmaceutical ingredient (API) CR 1447 – 4-hydroxytestosterone – and its formulation. Transdermal 4-week and 3-month toxicity studies were successfully performed in minipigs.
2014 – 2015
Conduct of clinical Phase I study with CR 1447 in patients with metastasizing breast cancer.
Primary and secondary endpoints were achieved with high tolerability, good transdermal delivery, sufficient dose-dependent plasma levels, and first signs of efficacy.
Start of oncology Phase II-Study