REVERSING RESISTANCE TO CHEMOTHERAPY
GLG Pharma has a number of promising new drug therapies for treating previously untreatable cancers and other cellular proliferative cellular diseases in Stage I and Stage II clinical trials. These new drugs are based on STAT3 inhibitor technology developed by the Dana Farber Cancer Institute (Boston, MA) and the Moffitt Cancer Center & Research Institute (Tampa, FL).
GLG Pharma therapies inhibit dysfunctional STAT3, a signaling protein essential to cell growth. In cancer cells, STAT3 proteins are continuously activated. There is no off mechanism to stop cancers from multiplying out of control.
GLG’s STAT3 inhibitors have been shown to reverse acquired resistance to 13 different chemotherapies and targeted therapies (including Trastuzumab and Bortezomib) in ten different types of cancer (including breast cancer and multiple myeloma).
A GLG Pharma drug candidate is currently in ongoing Phase II clinical trials to study its effect as a monotherapy for patients with relapsed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The patients are included in the study if treatment with at least one other therapy was unsuccessful. To date 17 patients have been treated. The highest dose of drug tested was well tolerated by all patients. All patients showed a reduction in p-STAT3, a biomarker that is used to monitor the response to the drug. Larger scale Phase II clinical trials are planned to begin in Poland in 2017 or sooner, funding and regulatory controls permitting an earlier start.
Clinical trials (Phase I/II) for triple negative breast cancer (TNBC) in combination with existing chemotherapy are planned to begin in Poland in 2016.
GLG’s STAT3 inhibitor trials Phase II will also begin, in Poland in 2016, for polycystic kidney diseases (PKD), autosomal dominant (adults) and autosomal recessive (pediatric).
HOW QUARK HELPED
Quark formed GLG Pharma to license the worldwide rights to develop and market pharmaceuticals based on the STAT3 inhibitor technology developed by the Dana Farber and Moffit cancer institutes. Quark took GLG Pharma public through a reverse merger on the Warsaw Stock Exchange.
INITIAL $2.7 MILLION EU GRANT
GLG Pharma received a $2.7 European Union grant to commence Phase I/II clinical trials for its triple negative breast cancer drug therapy. Approval is being awaited on a larger grant for clinical trials for polycystic kidney disease.