Sinobiomed Finds Recombinant Batroxobin Effective in Trial

Sinobiomed (SOBM.OB) reported its recombinant batroxobin significantly reduced bleeding time and volume in a Phase IIa trial. The goal of the trial was to determine the optimal dose for Phase IIb and III trials, plus demonstrate safety and efficacy. The drug, called rBat, has begun its Phase IIb test, which will be completed by the end of the year.

Because rBat is the product of a recombinant process, it will lessen the possibility of biological contamination and neurotoxicity of native batroxobin, which is extracted from the venom of pit vipers.

The trial was conducted in China by Sinobiomed’s 82% owned subsidiary, Shanghai Wanxing Bio-pharmaceuticals Co., Ltd. The double-blind, randomized, placebo-controlled Phase IIa Clinical Trial was conducted from December 2006 to August 2007 in five Chinese hospitals: Shanghai Changhai, Shanghai Huadong, Shanghai Huashan and Suzhou University's two affiliated hospitals.

There was only one adverse event possibly associated with rBat among the 119 patients enrolled in the Phase IIa trial. One patient had pain at the injection site, which disappeared within two days.

After the Phase IIa trial, Siobiomed chose a dose of 2KU rBat for the remaining tests. In the Phase IIb trial, surgical bleeding and bleeding not associated with surgery are being treated with rBat via either intramuscular injection or a combination of intramuscular and intravenous injections.

Sinobiomed is also developing an anti-bleeding kit around rBat for use in emergency situations, such as traffic accidents and combat.

Disclosure: none.