Access Pharma to Launch U.S. Cancer Drug Trial in China

Access Pharmaceuticals, Inc. (OTCQB:ACCP-OLD) of Texas revealed plans for a clinical trial of its solid tumor cancer drug, ProLindac, in China. The trial will be conducted by Access Pharma’s China partner, Aosaikang Medicinal Group (ASK), a company that is also responsible for manufacturing scale-up of ProLindac.

Access plans to use the China trial, along with a similar one conducted in South Korea by JCOM of Seoul, to help gain regulatory approval of ProLindac in the US and Europe. It projects the Asian clinical trials, which will be underwritten by its partners and designed to comply with FDA standards, will save Access between $20 and $30 million. Altogether, Access plans three trials in Asia that will test ProLindac in combination with other cancer-fighting drugs.

ProLindac uses Access’ nanoparticulate technology to deliver a DACH platinum active ingredient. ProLindac is designed to release its payload only in the acidic environment of tumors. The drug conveyed a five-fold increase of oxaliplatin to the tumor in Phase I trials. Access compares ProLindac to the Sanofi-Aventis (NYSE: SNY) drug Eloxatin, a drug with over $2 billion of sales annually. With ProLindac’s proprietary delivery system, Access expects to avoid the neurotoxic side effect of Eloxatin.

ProLindac has completed a Phase 2 monotherapy trial in Europe among ovarian cancer patients. In its Phase I trial, ProLindac showed efficacy in patients with solid tumors who had relapsed.

Access has received milestone payments from its two Asian partners as ProLindac has advanced in its development.

ASK was established in 1992, first as Nanjing Haiguang Applied Chemistry Research Institute. In 2003 Jiangsu Aosaikang Pharmaceutical Co., Ltd. was formed, backed by a combination of China and foreign funds. It has built three production workshops for bulk pharmaceuticals and three for preparations. It now claims the greatest variety of anti-tumor pharmaceuticals and proton pump inhibitors in China.

Disclosure: none.