Research overview
BNG-1 development milestones
Other research in progress

BNG-1 development milestones
BNG-1 is the result of our first R&D efforts. To confirm this drug's pharmacological activity and efficacy, we initially commissioned the Taiwan office of Canada's MDS Panlabs, an internationally-renown contract research and services company for the pharmaceutical industry, to perform general animal pharmacological testing on the drug.

These tests determined that the BNG-1 can inhibit platelet aggregation induced by arachidonic acid; prolongs bleeding time; is a mild cardiac stimulant; and can strengthen atrial contraction. Subsequent animal stroke experiments showed that the oral drug after ten days of use for preventing and treating cerebral arterial blockage, reduced the area of cerebral infarction by 44.09%. It was also found that when the drug was used after the occurrence of cerebral artery occlusion, the area of cerebral infarction was reduced by 46.29% after seven days of use.

We again commissioned MDS Panlabs in July 2002 to perform pharmacological testing where lab rats were given the drug for seven days starting three days after infarction (equivalent to giving the drug to humans 60 days after a stroke). This experiment found that the area of cerebral infarction was reduced by 66.19%.

A further in-vitro enzyme activity experiment found that BNG-1's mechanism of action is the inhibition of phosphodiesterase (PDE) activity. Interestingly, BNG-1 appears to be the first drug to selectively inhibit PDE. This experiment answered the biggest questions concerning the pharmacology of BNG-1, and facilitated more in-depth pharmacological experiments concerning the drug. Large animal pharmacology safety testing was then performed, and Taiwan's Development Center for Biotechnology (DCB) was commissioned to perform toxicological safety testing. All experimental results met safety and toxicological standards, and also adhered to human clinical trial regulations.

Clinical trials progress
General pharmacological experiments have verified that BNG-1 has no effect on blood lipid content, blood glucose content, or anti-microbial response. Pharmacology safety testing further showed that BNG-1 does not have any harmful effects on the central nervous system, gastrointestinal system, cardiovascular system, or urinary system. These findings indicate that BNG-1 shares the lack of side effects characteristic of traditional herbal medicines.

After chemical analysis review, stability confirmation, sanitation certification, GMP drug trial production, pharmacology results, safety testing, toxicology report, and clinical trials plan, the DOH Committee on Chinese Medicine and Pharmacy approved Phase II human clinical trials (official document Wei-Chung-Hui-Yao-Tzu No. 90007519 issued July 20, 2001). Phase II trials were subsequently completed on February 6, 2003. Phase II clinical trials assessed BNG-1's safety and efficacy in ischemic stroke patients; double-blind, placebo control, and random parallel experiments were conducted, along with trial use in conjunction with aspirin.

Based on the results of the foregoing Phase II clinical trials, the DOH Committee on Chinese Medicine and Pharmacy then approved Phase III clinical trials for BNG-1. Phase III trials were then conducted at seven medical center hospitals: Keelung Chang Gung, Taipei Veterans General Hospital, Taipei Mackay Memorial Hospital, Linkou Chang Gung, China Medical College, Chi Mei Hospital, and Kaohsiung Chang Gung. In accordance with Taiwan's Good Clinical Practices (GCP) and clinical trials regulations, Phase III consisted of random, double-blind trials, with a total of 114 patients enrolled. Results were presented to the DOH Committee on Chinese Medicine and Pharmacy for review on May 7, 2007.

BrainGenesis is looking forward to successfully completing new drug application procedures with the DOH Bureau of Pharmaceutical Affairs for BNG-1, and see it not only as an achievement for the company but also a huge incentive for the continued future development of Taiwan's biotech pharmaceutical industry.