PR86785

SEOUL, Nov. 20, 2020, /PRNewswire=KYODO JBN/--

GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide

drug based on telomerase modification has released further positive data at the

Korean Dementia Association's Fall Conference from a Phase II trial in

Alzheimer's disease of lead candidate GV1001. Previously the company announced

GV1001 was well tolerated and safe and the primary endpoint was achieved with

notable improvements in Severe Impairment Battery (SIB) scores. The newly

released data also shows a statistically significant improvement in the

Neuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer's

Disease Cooperative Study-Activities of Daily living (ADCS-ADL). Based on these

results, the company is now planning to submit a Phase III IND application.

GemVax's GV1001 Phase II clinical trial evaluated the safety and efficacy of

subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients

with moderate-to-severe Alzheimer's disease already receiving donepezil for

more than three months, at 12 medical institutions. PI Professor Seong-Ho Koh,

at Hanyang University Guri Hospital  said, "The Severe Impairment Battery

(SIB), the primary endpoint of this clinical study, showed an statistically

significant greater improvement in the group treated with GV1001 1.12 mg

compared with the control group treated with donepezil alone, which showed 7.11

difference in the overall SIB score. Among the secondary outcome results, the

group treated with GV1001 1,12mg had a significant greater improvement in the

Neuropsychiatry Inventory (NPI) scores compared to the control group.

Furthermore, although found to be statistically not significant, the other

secondary outcome, the Alzheimer's disease cooperative study, Activities of

Daily living (ADCS-ADL) score showed an apparent trend in improvement similar

to the SIB results."

Kim Sang-Jae, chairman of GemVax "Combined with the notable improvement in SIB

scores in patients with moderate-to-severe Alzheimer's disease, these

significant results in NPI and ADCS-ADL scores are extremely encouraging. We

have decided to submit a Phase III in Korea to see if it is possible to

demonstrate improvement in a larger group of  moderate-to-severe patients."

Professor Koh, agrees, "If efficacy and safety results of GV1001 in the phase

III clinical trial are the same as or superior to the Phase II clinical trial,

it will be able to establish itself as a game-changer in Alzheimer's disease

treatment".

For more information visit: www.gemvax.com

Media Contact

Richard Hayhurst

T: +44-7711-821-527

E: Richard@rhapr.eu  

SOURCE: GemVax & KAEL