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Memory Pharmaceuticals Announces Positive Preliminary Phase 1
Cognitive Data for MEM 3454
MONTVALE, N.J., February 21, 2006 /PRNewswire-FirstCall/ -- Memory Pharmaceuticals Corp. today announced preliminary cognitive data from the multiple ascending dose (MAD) study of the Phase 1 clinical trial program of MEM 3454, the Company's lead drug candidate in its Nicotinic Alpha-7 Agonist program. Cognition data generated in this MAD study, using the Cognitive Drug Research (CDR) battery, demonstrated that a 15 milligram dose of MEM 3454, administered once daily for a period of 13 days showed a statistically significant effect on the Quality of Episodic Secondary Memory (QESM), one of the study's primary efficacy variables.
"The results from the CDR battery are promising, especially in light of the small sample size, and importantly, support our belief that MEM 3454 has potential as a new therapeutic approach to treat important central nervous system (CNS) disorders such as schizophrenia and Alzheimer's disease," stated David A. Lowe, Ph.D., Chief Scientific Officer. "Based on the data we have to date, we are moving forward with a Phase 2a trial that we plan to commence during the first half of this year."
The MAD study was the final segment in a four-segment single-center Phase 1 clinical trial program of MEM 3454 conducted in Toronto, Canada, under Clinical Trial Applications that the Company filed with Health Canada. The MAD study was a randomized, double-blind, placebo-controlled study of three doses of MEM 3454 (15 milligrams, 50 milligrams, and 150 milligrams) and involved 48 healthy young male and female volunteers. The primary purpose of this MAD study was to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of MEM 3454 in healthy volunteers. A secondary objective of the study was to assess the cognitive effects of the doses tested using the CDR battery.
QESM is a composite score derived from memory tests in the CDR battery that measure the efficiency with which study participants are able to remember words and pictures. After oral administration of 15 milligrams of MEM 3454 once per day for 13 days, there was a statistically significant effect on the QESM of the healthy volunteers. This effect at 15 milligrams is supported by the Company's preclinical work with MEM 3454. The other doses administered in the study did not show a similarly statistically significant effect, although there was a trend toward efficacy at the 50 milligram dose. Other domains in the CDR battery measure other cognitive effects such as psychomotor speed and attention, and while trends toward improvement were also seen on these domains at 15 milligrams of MEM 3454, the results were not as substantial as those obtained for the QESM domain.
The Company plans to release further results from the Phase 1 clinical trial program of MEM 3454 during the second quarter of 2006.
The nicotinic alpha-7 receptor is a highly specialized receptor found in the CNS. Compounds acting on this receptor could be beneficial in the treatment of schizophrenia and Alzheimer's disease, as well as other psychiatric and neurological disorders. MEM 3454 is the Company's lead drug candidate from its nicotinic alpha-7 agonist program.
About the MEM 3454 Phase 1 Clinical Trial
The single-center Phase 1 clinical trial program consisted of four segments: a double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of MEM 3454, which involved 56 healthy young male volunteers; a standard single-dose food interaction study, which involved 12 volunteers; a single ascending dose study, which involved 15 elderly volunteers; and the MAD study.
About the Company
Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on developing innovative drugs for the treatment of debilitating CNS disorders such as Alzheimer's disease, schizophrenia, depression, bipolar disorder, vascular dementia, mild cognitive impairment, Parkinson's disease and memory impairments associated with aging. For additional information, please visit our website at http://www.memorypharma.com .
Memory Pharmaceuticals Announces Positive Preliminary Phase 1
Cognitive Data for MEM 3454
MONTVALE, N.J., February 21, 2006 /PRNewswire-FirstCall/ -- Memory Pharmaceuticals Corp. today announced preliminary cognitive data from the multiple ascending dose (MAD) study of the Phase 1 clinical trial program of MEM 3454, the Company's lead drug candidate in its Nicotinic Alpha-7 Agonist program. Cognition data generated in this MAD study, using the Cognitive Drug Research (CDR) battery, demonstrated that a 15 milligram dose of MEM 3454, administered once daily for a period of 13 days showed a statistically significant effect on the Quality of Episodic Secondary Memory (QESM), one of the study's primary efficacy variables.
"The results from the CDR battery are promising, especially in light of the small sample size, and importantly, support our belief that MEM 3454 has potential as a new therapeutic approach to treat important central nervous system (CNS) disorders such as schizophrenia and Alzheimer's disease," stated David A. Lowe, Ph.D., Chief Scientific Officer. "Based on the data we have to date, we are moving forward with a Phase 2a trial that we plan to commence during the first half of this year."
The MAD study was the final segment in a four-segment single-center Phase 1 clinical trial program of MEM 3454 conducted in Toronto, Canada, under Clinical Trial Applications that the Company filed with Health Canada. The MAD study was a randomized, double-blind, placebo-controlled study of three doses of MEM 3454 (15 milligrams, 50 milligrams, and 150 milligrams) and involved 48 healthy young male and female volunteers. The primary purpose of this MAD study was to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of MEM 3454 in healthy volunteers. A secondary objective of the study was to assess the cognitive effects of the doses tested using the CDR battery.
QESM is a composite score derived from memory tests in the CDR battery that measure the efficiency with which study participants are able to remember words and pictures. After oral administration of 15 milligrams of MEM 3454 once per day for 13 days, there was a statistically significant effect on the QESM of the healthy volunteers. This effect at 15 milligrams is supported by the Company's preclinical work with MEM 3454. The other doses administered in the study did not show a similarly statistically significant effect, although there was a trend toward efficacy at the 50 milligram dose. Other domains in the CDR battery measure other cognitive effects such as psychomotor speed and attention, and while trends toward improvement were also seen on these domains at 15 milligrams of MEM 3454, the results were not as substantial as those obtained for the QESM domain.
The Company plans to release further results from the Phase 1 clinical trial program of MEM 3454 during the second quarter of 2006.
The nicotinic alpha-7 receptor is a highly specialized receptor found in the CNS. Compounds acting on this receptor could be beneficial in the treatment of schizophrenia and Alzheimer's disease, as well as other psychiatric and neurological disorders. MEM 3454 is the Company's lead drug candidate from its nicotinic alpha-7 agonist program.
About the MEM 3454 Phase 1 Clinical Trial
The single-center Phase 1 clinical trial program consisted of four segments: a double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of MEM 3454, which involved 56 healthy young male volunteers; a standard single-dose food interaction study, which involved 12 volunteers; a single ascending dose study, which involved 15 elderly volunteers; and the MAD study.
About the Company
Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on developing innovative drugs for the treatment of debilitating CNS disorders such as Alzheimer's disease, schizophrenia, depression, bipolar disorder, vascular dementia, mild cognitive impairment, Parkinson's disease and memory impairments associated with aging. For additional information, please visit our website at http://www.memorypharma.com .
posted by Jones Lang LaSalle NJ News Blog at 4:13 PM
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