Under the terms of the agreement, Haichang will develop a nano-liposomal formulation of RX-0201 using its proprietary QTsome™ technology and conduct certain pre-clinical and clinical activities through completion of a Phase IIa proof-of-concept clinical trial for the treatment of HCC.
Any clinical trials conducted by Haichang will be designed to meet both U.S. and Chinese regulatory requirements. Haichang will fund all research and development activities through completion of the Phase IIa clinical trial.
The parties will share in an agreed ratio downstream licensing fees and royalties paid by third parties in connection with the further development and commercialization of the nano-liposomal formulation of RX-0201 for the treatment of HCC.
Rexah CEO Dr Peter Suzdak said: “We are delighted to enter into this collaboration to take RX-0201 forward in hepatocellular carcinoma.
“We are impressed with Haichang’s QTsome™ technology. It has the potential to target RX-0201 to the liver and to promote uptake into cancer cells to enhance efficacy. We are also very pleased to have non-dilutive funding to take the program through Phase IIa proof-of-concept studies.”
Haichang CEO Dr Ben Zhao said: “The incidence of liver cancer is growing worldwide, and especially in Asia.
“There are very few treatment options for patients and unfortunately, the prognosis for patients with advanced disease is very poor. Akt-1 is an important signaling protein in liver cancer and we are excited about the potential for RX-0201. It is an ideal candidate for our liposomal technology and we look forward to advancing the development of RX-0201 in collaboration with Rexahn.”
In connection with the agreement with Haichang, Rexahn plans to discontinue the internally funded programs of Archexin and will cease enrollment in the current Phase IIa clinical study of Archexin in metastatic renal cell carcinoma (mRCC). Patients currently enrolled in the trial will continue to be followed.
Hepatocellular carcinoma (liver cancer) is the sixth most common type of cancer worldwide and the second-leading cause of cancer-related deaths.
Each year approximately 780,000 new cases of liver cancer are diagnosed worldwide and over 740,000 people will die of the disease.1 The incidence of liver cancer in the U.S. has more than tripled since 1980.2 It is estimated that there will be approximately 41,000 new cases of liver and intrahepatic bile duct cancer and 29,000 deaths from these diseases in the U.S. in 2017.3