Research overview
BNG-1 development milestones
Other research in progress

Research overview
Current chemical drugs are dogged by limited efficacy and such problems as side effects and drug resistance. Because the scientific method and modern pharmacological technology has verified that traditional Chinese herbal medicines yield significant efficacy against disease, the medical establishment is gradually gaining respect for the development and use of herbal medicines. The herbal preparation BNG-1, a drug candidate developed by BrainGenesis, is based on four traditional Chinese medical materials together with four other secondary materials. BNG-1's main expected effect is to prevent and treat infarction-type stroke. We hope to rely on verification from rigorous clinical trials to make BNG-1 the world's first herbal preparation capable of preventing and treating stroke.

Stroke and problems with conventional treament methods
Stroke is one of the most common diseases in an aging society. According to DOH statistics, in the Taiwan area 13,141 and 12,009 persons died due to cerebrovascular disease in 2001 and 2002 respectively. Cerebrovascular disease has become the second greatest cause of death in Taiwan over the last few years, and its incidence is still on the rise. Stroke patients often die or become disabled due to lack of suitable drugs. Apart from the immense suffering it causes to patients, stroke also places a huge burden on individuals and national health care budgets in terms of the high cost of treating and caring for stroke patients. While aspirin is currently used to prevent stroke, and conventional anticoagulants and thrombolytics are used to treat stroke, pharmaceuticals offer only limited efficacy in preventive and therapeutic application. And although many folk remedies are popular, no Chinese herbal medicines with clear efficacy have reached the market. No Chinese herbal medicines have yet passed the rigorous scientific assessment process used for Western pharmaceuticals. Although BNG-1 is an herbal medicine product, its success in passing pre-clinical animal experiments and phase 2 and 3 clinical trials shows that it may offer true efficacy to stroke patients.

Hemorrhagic stroke is usually treated by surgically removing the blood clot in order to reduce blood pressure, followed by administration of anti-hypertensive drugs to control hypertension. Infarction-type strokes are usually treated by injection of thrombolytics to dissolve the clot, following with the administration of drugs such as aspirin, ticlopidine, dipyridamole, and clopidogrel to inhibit platelet aggregation and avoid further infarction.

Thrombolytic drugs currently on the market include Streptokinase, Urokinase, Activase, Reteplase, and Teneteplase. Among the most commonly used thrombolytics, Streptokinase is derived from microbial cultures, and therefore often induces allergic reactions. And although Urokinase is a human enzyme, it is not a specific hemolytic, and readily induces the side effect of bleeding. Although Activase (a first-generation tissue plasminogen activator-or tPA-an emergency stroke drug treatment) is an excellent thrombolytic, it only has a half-life of 3-4 minutes. It is also very costly-with one injected dose costing US$2,200, and is difficult to use intravenously. Even more importantly, 22% of patients using TPAs experience mild bleeding, while 6% experience severe bleeding (including the 4% who experience intracranial bleeding). The side effect of bleeding may cause death in severe cases.

Although many clinical trials have reported that TPAs open congested blood vessels and reduce the death rate from stroke, the need to use them during a short period after a stroke has occurred, as well as their side effects and high price, ensure that only 10% of acute myocardial infarction patients receive TPA treatment. According to the results of clinical trials conducted under the auspices of the National Institute of Health in the US, acute ischemic stroke patients have a so-called "critical window", a period of 3-6 hours after the stroke occurs during which to receive treatment. Clinical results have shown that patients who are taken to a hospital and receive thrombolytics within 90 minutes fare the best. But if no suitable drugs are available, even viable patients often gradually suffer some degree of nerve function impairment, and a huge amount of medical and social resources must be spent on these patients' treatment and care.

BrainGenesis' BNG-1 is the result of combining the new drug development model used in Europe and the US, together with traditional Chinese medicine (TCM). The first product to be developed using plant materials and newly prepared active components, BNG-1 can prevent and treat infarction-type strokes. BNG-1's clinical design escapes some of the time problems affecting existing stroke drugs. Patients who had suffered a stroke during the previous ten days were included in the Phase II clinical trials, and patients who had had a stroke received BNG-1 treatment for 28 days in Phase II and Phase III trials, with all patients demonstrated significant benefit during such trials. BNG-1 is thus the world's only stroke drug that is not subject to the urgent need to begin therapy during the critical window.

BNG-1 has smoothly completed Phase III clinical trials, and has been found to be safe and free of side effects. The data also shows that it offers amazing efficacy. If in the near future it can obtain an NDA permit from the DOH Bureau of Pharmaceutical Affairs, BNG-1 will provide stroke patients with an innovative, highly effective preventive and therapeutic drug. At the same time, it will also be the first time that a Chinese herbal medicine has been developed as a new drug. The success of BNG-1 will inspire greater confidence among pharmaceutical industry investors, and ignite a surge of development in Taiwan's biotechnology and pharmaceutical industries.