| Abstract: | |
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. |
| Patent information: | |
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 |
|
Type of business
relationship sought: | |
All can be considered; licensing, co-development, etc. |
