Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Oncolix, for conducting clinical studies for its analogue protein, Prolanta, to treat ovarian cancer. The trials will be conducted in the US as well as sites A and B in the Ukraine.
Ovarian Cancer is one of the leading causes of cancer-related death in women and gynecologic death. 80-90% of patients initially respond to chemotherapy but of those, only 10-30% have long-term survival since the majority relapse. Currently, cytotoxic drugs (chemotherapy) are the only forms of therapy that are available, but as shown, they are not particularly efficacious. Clearly there is a great need for new forms of treatment.
Prolanta is a prolactin receptor antagonist with a single amino acid mutation. This mutation would allow Prolanta to interfere with the binding of two normal prolactin receptors, which would usually cause cancer cell proliferation and also resistance to chemotherapy. It does so through its ability to bind to one prolactin receptor but not the other, blocking prolactin from initiating growth pathways such as the Jak2/STAT pathway. There is significant evidence that this mutated form of prolactin also induces autophagy in ovarian cancer cells.
The purpose of this Phase I study is to evaluate the safety, tolerability and pharmacokinetic parameters of Prolanta monotherapy in patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three dosing levels will also be examined to establish the recommended Phase II dose.
About Clinical Accelerator
Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological, nutraceutical and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.
Oncolix is a Houston, Texas-based, clinical-stage bio-pharmaceutical company dedicated to the development of Prolanta for the treatment of breast, ovarian and other cancers. Oncolix has received approval by the FDA to designate Prolanta as an Orphan Drug for ovarian cancer due to the unmet medical needs.