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Abstract: |
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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<3 (determining ease of patient movement)
3. Barthel Index = 60 (degree of ease in performing common daily activities)
Subjects were classified into two subgroups: older (age=65 years old) and younger (age<65 years old). For the younger subgroup, patients who were administered a combination of BNG-1 and aspirin had a significantly more favorable response, according to the criteria above, than patients treated with aspirin alone (BNG-1 group: 53.6%, Aspirin group: 14.3%) (53.6% compared to 14.3% in ITT, p-value=0.0307, and 66.7% compared to 9.1% in PP, p-value=0.0280) (P<0.05%).
Additional clinical studies may be required for registration in other countries. |
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Patent information: |
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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 |
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Type of business
relationship sought: |
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All can be considered; licensing, co-development, etc. |
