A novel mixture of traditional Chinese medicines with anti-platelet aggregation and anti-thrombotic activity for both prevention and treatment of cerebral stroke.

PBNG-1, a drug candidate being derived from a novel mixture of traditional Chinese medicines, has shown the following preclinical pharmacologic activity:

1. BNG-1 at 300 g/ml inhibited arachidonic acid-induced platelet aggregation in vitro.
2. BNG-1 (1000 mg/kg x 8) prolonged 60.4% of bleeding time in mice in vivo.
3. BNG-1 [(1 g/kg orally for 10 consecutive days beginning 7 days before and 3 days after middle cerebral artery occlusion (MCAO), (1 g/kg beginning 7 days after MCAO) exhibited 44% and 55.8% acute neuroprotection effect on rats with middle cerebral artery occlusion (MCAO), respectively.
4. BNG-1 inhibited phosphodiesterase (PDE) isoforms with potency order of the following rank: PDE1>PDE3>PDE6>PDE2>PDE4>PDE5.
5. Through an extensive safety pharmacology assessment of high doses of BNG-1, no threat to the normal vital functions of the cardiovascular, renal, respiratory or central nervous system in the animals was discovered.

Phase II clinical trials (under the regulations for new drugs from Taiwan's Department of Health (DOH), Bureau of Pharmaceutical Affairs), confirmed the safety and feasibility of BNG-1 consumed together with aspirin in patients with acute ischemic stroke, with no adverse effects in humans shown.

In Taiwan DOH Phase III trials, a combination of BNG-1 and aspirin in treating acute ischemia stroke showed a more favorable response than aspirin alone at the end of week 12 of the study, according to the following criteria:

1. Survival of the patient
2. Modified Rankin Scale

Phase III

(Taiwan DOH Phase III)

1. Taiwan: Patent No. I 275396
2. China: Patent No. ZL 01 1 36770.9
3. Singapore: Patent No. 111058
4. Malaysia: Patent No. MY-128772-A
5. Japan: Patent No. 3930365
6. Korea: Patent No. 0502947
7. U. Patent: No. US 6,936.282 B2
8. US: Patent No. US 6,872.409 B2
9. Australia: Patent No. 783302
10. Europe: Patent No. 1358887

All can be considered; licensing, co-development, etc.