Anavex Life Sciences Announces First Patient Dosed in EXCELLENCE Phase 2/3 Clinical Trial of ANAVEX®2-73 (Blarcamesine) in P...
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developingdifferentiated therapeutics for the treatment of neurodegenerativeand neurodevelopmental diseases including Alzheimer’s disease,Parkinson’s disease, Rett syndrome and other central nervous system(CNS) diseases, today announced that the first patient was dosed inthe EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 clinical trial for thetreatment of Rett syndrome with ANAVEX®2-73(blarcamesine).
The Phase 2/3 study will use a convenientonce-daily oral liquid ANAVEX®2-73 (blarcamesine)formulation to treat Rett syndrome. Safety and efficacy will beinvestigated in at least 69 patients over a 12-week treatmentperiod including ANAVEX®2-73-specific precision medicinebiomarkers. All patients who participate in the study will beeligible to receive ANAVEX®2-73 (blarcamesine) under avoluntary open label extension protocol.
This represents the 3rd ongoingclinical study in Anavex’s Rett Syndrome Program: U.S. RTT(ANAVEX®2-73-RS-001)1, AVATAR(ANAVEX®2-73-RS-002)2 and EXCELLENCE(ANAVEX®2-73-RS-003)3.
ANAVEX®2-73 (blarcamesine) had previously received FastTrack designation, Rare Pediatric Disease designation and OrphanDrug designation from the FDA for the treatment of Rettsyndrome.
For parents who wish to learn more aboutthe EXCELLENCE pediatric Phase 2/3 Rett syndrome clinical study,please visit the website,www.rettsyndrometrial.com.
Rett Syndrome Association of Australia (RSAA)will make the necessary bookings and pay for them directly so asnot to burden and leave participants and their families out ofpocket for major expenses whilst directly participating in theEXCELLENCE trial. Please contact Claude Buda, RSAA President,directly by phone or email for any inquiries:
Claude Buda, RSAA President
Phone: +61 (0)411 089 156
Email: claudebuda@rettaustralia.org.au
“We are delighted to expand the ANAVEX®2-73(blarcamesine) treatment program for Rett syndrome toinclude pediatric patients. This is the 3rd ongoingclinical study within the Anavex Rett syndrome program,” saidChristopher U Missling, PhD, President and Chief Executive Officerof Anavex. “In addition to Rett syndrome, Anavex has ongoingclinical development programs for ANAVEX®2-73(blarcamesine) for the treatment of Alzheimer’sdisease4 and Parkinson’s diseasedementia5.”
About Rett Syndrome
Rett syndrome is a rare, non-inherited geneticpostnatal progressive neurodevelopmental disorder that occursalmost exclusively in girls and leads to severe impairments,affecting nearly every aspect of the child’s life: their ability tospeak, walk, eat and even breathe easily. The hallmark of Rettsyndrome is near constant repetitive hand movements while awake. Itis characterized by normal early growth and development (6 to 18months) followed by a slowing of development, loss of purposefuluse of the hands, distinctive hand movements, slowed brain and headgrowth, problems with walking, seizures and intellectualdisability. There is currently no cure for Rett syndrome andtreatment of the disorder is symptomatic. Management of symptoms isdone through a multidisciplinary approach utilizing medication formotor difficulties, breathing irregularities and control ofseizures through anticonvulsant drugs. Rett syndrome is caused bymutations in the MECP2 gene and strikes all racial andethnic groups and occurs worldwide in approximately one in every10,000 to 15,000 live female births.
About ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 (blarcamesine) activatesthe Sigma-1 receptor (S1R) protein, which serves as a molecularchaperone and functional modulator involved in restoringhomeostasis. In a Phase 2a Alzheimer’s disease (AD) study,ANAVEX®2-73 showed dose dependent improvement in exploratoryendpoints of cognition (MMSE) and activities of daily living(ADCS-ADL). The ANAVEX®2-73 Phase 2 Rett syndrome study designincludes genomic biomarkers of response identified in theANAVEX®2-73 Phase 2a AD study. Studies of ANAVEX®2-73(blarcamesine) in a mouse model of Rett syndrome, carryinga heterozygous Mecp2-null mutation and presenting withneurological impairments that mimic the human disorder,demonstrated improvements at both young ages (~6 weeks) andadulthood (7 months). Chronic oral administration of ANAXEX®2-73(blarcamesine) led to significant improvements in multiplemotor, sensory, and autonomic phenotypes of relevance to Rettsyndrome, including motor coordination and balance, acoustic andvisual responses, hindlimb clasping (resembling the characteristichand stereotypies), and episodes of apnea. Notably, these changeswere dose related and also evident in animals at an advanced stageof pathology. These experiments were sponsored byRettsyndrome.org.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is apublicly traded biopharmaceutical company dedicated to thedevelopment of differentiated therapeutics for the treatment ofneurodegenerative and neurodevelopmental disorders includingAlzheimer’s disease, Parkinson’s disease, Rett syndrome and othercentral nervous system (CNS) diseases, pain and various types ofcancer. Anavex’s lead drug candidate, ANAVEX®2-73(blarcamesine), recently completed a successful Phase 2aclinical trial for Alzheimer’s disease. ANAVEX®2-73(blarcamesine) is an orally available drug candidate thatrestores cellular homeostasis by targeting sigma-1 and muscarinicreceptors. Preclinical studies demonstrated its potential to haltand/or reverse the course of Alzheimer’s disease. ANAVEX®2-73(blarcamesine) also exhibited anticonvulsant,anti-amnesic, neuroprotective and anti-depressant properties inanimal models, indicating its potential to treat additional CNSdisorders, including epilepsy. The Michael J. Fox Foundation forParkinson’s Research previously awarded Anavex a research grant,which fully funded a preclinical study to develop ANAVEX®2-73(blarcamesine) for the treatment of Parkinson’s disease.ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is apromising preclinical drug candidate demonstratingdisease-modifying activity against the major hallmarks ofAlzheimer’s disease in transgenic (3xTg-AD) mice, includingcognitive deficits, amyloid and tau pathologies. In preclinicaltrials, ANAVEX®3-71 has shown beneficial effects on mitochondrialdysfunction and neuroinflammation. Further information is availableat www.anavex.com. You can also connect with the companyonTwitter,FacebookandLinkedIn.
Forward-Looking Statements
Statements in this press release that are notstrictly historical in nature are forward-looking statements. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties.Actual events or results may differ materially from those projectedin any of such statements due to various factors, including therisks set forth in the Company’s most recent Annual Report on Form10-K filed with the SEC. Readers are cautioned not to place unduereliance on these forward-looking statements, which speak only asof the date hereof. All forward-looking statements are qualified intheir entirety by this cautionary statement and Anavex LifeSciences Corp. undertakes no obligation to revise or update thispress release to reflect events or circ*mstances after the datehereof.
___________________________
1 ClinicalTrials.gov Identifier: NCT03758924
2 ClinicalTrials.gov Identifier: NCT03941444
3 ClinicalTrials.gov Identifier: NCT04304482
4 ClinicalTrials.gov Identifier: NCT03790709
5 ClinicalTrials.gov Identifier: NCT03774459
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors &Media:
Email: ir@anavex.com
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(\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93844480\/anavex-life-sciences-to-present-at-the-h-c-wainwr","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1715686200,"date":"Tue May 14, 2024 ","time":"7:30 AM (4 weeks ago)","full_date":"May 14, 2024 7:30 AM","post_time":"May 14 2024","article_id":93844480,"source_id":"globe","media_url":null,"press_release":true},{"headline":"Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More","short_text":" Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More\nPR Newswire\nNEW YORK, May 10, 2024 NEW YORK, May 10...","one_line_short_text":" Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More\nPR...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93822893\/shareholders-that-lost-money-on-anavex-life-scienc","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1715334300,"date":"Fri May 10, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 10, 2024 5:45 AM","post_time":"May 10 2024","article_id":93822893,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Form 10-Q - Quarterly report [Sections 13 or 15(d)]","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93818920\/form-10-q-quarterly-report-sections-13-or-15d","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715286955,"date":"Thu May 09, 2024 ","time":"4:35 PM (1 month ago)","full_date":"May 9, 2024 4:35 PM","post_time":"May 09 2024","article_id":93818920,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Form 8-K - Current report","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93814389\/form-8-k-current-report","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715256030,"date":"Thu May 09, 2024 ","time":"8:00 AM (1 month ago)","full_date":"May 9, 2024 8:00 AM","post_time":"May 09 2024","article_id":93814389,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences Reports\u00a0Fiscal 2024 Second Quarter Financial Results and Provides Business Update","short_text":"Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","one_line_short_text":"Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93813665\/anavex-life-sciences-reports-fiscal-2024-second-qu","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1715254200,"date":"Thu May 09, 2024 ","time":"7:30 AM (1 month ago)","full_date":"May 9, 2024 7:30 AM","post_time":"May 09 2024","article_id":93813665,"source_id":"globe","media_url":null,"press_release":true},{"headline":"The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders","short_text":" The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders\nPR Newswire\nNEW YORK, May 7, 2024 NEW YORK, May 7, 2024...","one_line_short_text":" The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders\nPR...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93789431\/the-gross-law-firm-announces-the-filing-of-a-secur","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1715075100,"date":"Tue May 07, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 7, 2024 5:45 AM","post_time":"May 07 2024","article_id":93789431,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93781112\/form-defa14a-additional-definitive-proxy-solicit","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1714989813,"date":"Mon May 06, 2024 ","time":"6:03 AM (1 month ago)","full_date":"May 6, 2024 6:03 AM","post_time":"May 06 2024","article_id":93781112,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL","short_text":" Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL\nPR Newswire\nNEW YORK, May 3, 2024 NEW YORK, May...","one_line_short_text":" Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93774016\/anavex-life-sciences-corporation-sued-for-securiti","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1714729500,"date":"Fri May 03, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 3, 2024 5:45 AM","post_time":"May 03 2024","article_id":93774016,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results\u00a0on Thursday, May 9th, 2024","short_text":"NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated...","one_line_short_text":"NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93766233\/anavex-life-sciences-to-announce-fiscal-2024-secon","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1714649400,"date":"Thu May 02, 2024 ","time":"7:30 AM (1 month ago)","full_date":"May 2, 2024 7:30 AM","post_time":"May 02 2024","article_id":93766233,"source_id":"globe","media_url":null,"press_release":true},{"headline":"May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL","short_text":" May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL\nPR Newswire\nNEW YORK, April 26, 2024 NEW YORK, April 26, 2024 \/PRNewswire\/ -- The Gross Law Firm issues...","one_line_short_text":" May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL\nPR Newswire\nNEW YORK, April 26, 2024 NEW YORK, April 26...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93721517\/may-13-2024-deadline-contact-the-gross-law-firm","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1714124700,"date":"Fri Apr 26, 2024 ","time":"5:45 AM (2 months ago)","full_date":"April 26, 2024 5:45 AM","post_time":"April 26 2024","article_id":93721517,"source_id":"prnus","media_url":null,"press_release":true}],"Preferred Contributors": ""}},created: function () {this.loaded = true;Vue.nextTick(function(){});}});});
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