AVXL (biotech scam, buy only for "run up", sell before catalyst events like trial results release)
Anavex Life Sciences Corp., a biopharmaceutical company, is engaged in the discovery and development of drugs for the treatment of Alzheimers disease, central nervous system diseases, and pain and various cancers. Its lead drug candidates include ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept), which is in a Phase IIa clinical trial for the treatment of Alzheimers disease. The companys product candidates also include ANAVEX 3-71, a drug candidate that is effective in very small doses against the major Alzheimers hallmarks in transgenic (3xTg-AD) mice via sigma-1 receptor activation and M1 muscarinic allosteric modulation; ANAVEX 1-41, a sigma-1 agonist for neuroprotective application; and ANAVEX 1037, ANAVEX 1079, and ANAVEX 1519 for the treatment of pain and various cancers. Anavex Life Sciences Corp. was founded in 2006 and is headquartered in New York, New York.
Company looks like usual biotech scam that want to attract naive investors by AD drug. The strategy is simple: buy it for run up and sell before catalyst event like phase
Phase 2a Dose Finding, PK/PD and 6 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease
This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Anavex Life Sciences Corp.
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
First received: August 31, 2014
Last updated: June 27, 2015
Last verified: April 2015
History of Changes
The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship between dosing regimen and pharmacodynamics efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.
Condition Intervention Phase
Drug: ANAVEX2-73 Oral
Drug: ANAVEX2-73 Intravenous
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 6-Month Open Label Follow-Up Period
Further study details as provided by Anavex Life Sciences Corp.:
Primary Outcome Measures:
To determine maximum tolerated dose of Anavex2-73. [ Time Frame: 36 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
PK sampling- blood test results [ Time Frame: First part (PART A), first period (hours): 1, 48, 264; second period (hours): 1, 72, 264; extension period (PART B): Week 1, 12 and 26. ] [ Designated as safety issue: No ]
Mini-mental state examination score (MMSE) [ Time Frame: Baseline, and during the extension period at Week 1, 12 and 26. ] [ Designated as safety issue: No ]
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) [ Time Frame: Baseline, and during the extension period at Week 1, 12 and 26 ] [ Designated as safety issue: No ]
Cogstate Brief Battery (CBB) Score and International Shopping List Task (ISLT) Score [ Time Frame: At baseline, Day 1, 2, 6, 9, 12 of Period 1 and Day 1, 2, 6, 9, 12 of Period 2 and during the extension period at Week 12 and 26. ] [ Designated as safety issue: No ]
Electroencephalographic activity, including event-related potentials (EEG/ERP) [ Time Frame: baseline, Day 1, 5, 11 of Period 1 and Day 1, 5, 11 of Period 2 and, Week 12 and 26 of the extension period ] [ Designated as safety issue: No ]
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline at Period 1 ] [ Designated as safety issue: No ]
Rosen Modified Hachinski Ischemic Score (RM/HIS10) [ Time Frame: Baseline at period 1 ] [ Designated as safety issue: No ]
Estimated Enrollment: 32
Study Start Date: December 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)