is...optimistic for the future of CNS conditions thanks to Anavex Life Sciences.
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Embattled Alzheimer’s Researcher Is Charged With Fraud
Hoau-Yan Wang, a professor at City College, published studies supporting simufilam, now in advanced clinical trials.
https://www.nytimes.com/2024/06/28/health/wang-cassava-alzheimers-fraud.html
https://www.science.org/content/article/u-s-levels-fraud-indictment-cuny-scientist-who-helped-alzheimer-s-drug-developer
https://www.yahoo.com/news/us-professor-charged-manipulating-data-195232162.html
https://www.upi.com/Top_News/US/2024/06/28/DOJ-professor-fraud-Hoau-Yan-Wang/2501719598937/
Hoau-Yan Wang has to face some music.
Maybe the Lithium Niobate Modulator Platform is for some folks, but most of us are invested in AVXL. 😜
https://seekingalpha.com/article/118940-avanex-corp-f2q09-qtr-end-12-31-08-earnings-call-transcript
Looks like if the original owners of AVNX held on to their conversions all the way through to Lumentum from Bookham and Oclara, then they were rewarded! 🤑
Hmmm…
https://clinicaltrials.gov/study/NCT04314934?tab=history&a=5#version-content-panel
Primary Completion
2024-07-31 [Estimated]
Study Completion
2024-07-31 [Estimated]
Looking forward to the time that Blarcamesine is amongst the selected medicines…
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024
2025 could very well be PRIME time! 🤞
Madrid (Spain) October 29 - November 1, 2024
Timing would be just about right.
What’s more is that the actual dosing was then adjusted to correspond with bedtime to minimize the side effect of mild dizziness. And boom…a better night’s rest, PLUS a full night for the small molecules to be distributed through the patient’s bodies.
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), announced today that it will report its second quarter 2024 financial results before the market opens on Wednesday, August 7, 2024. A press release detailing the quarterly results will be issued the same day approximately one hour prior to the webcast.
MannKind will host a webcast beginning at 9:00 a.m. Eastern Time for investors, media, and the general public. Participating in the conference call from MannKind will be Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available in the same location within 24 hours following the call and be accessible for approximately 90 days.
And here I thought my purchasing days were over! 🤷♂️
Game on! 💵💵💵
NEW YORK – July 28, 2024
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today presented comprehensive results from the Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease (AD). The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Scientific Advisory Board at the 2024 Alzheimer's Association International Conference (AAIC).
Blarcamesine significantly slowed clinical progression by 38.5% and 34.6% at 48 weeks in 50 mg and 30 mg groups vs. placebo, respectively, on the prespecified primary cognitive endpoint ADAS-Cog13. As specified in the March 2024 FDA Guidance for Early AD, a sole cognitive measure can serve as the primary endpoint for early Alzheimer’s trials.[1] The protocol was designed with ADAS-Cog13 and ADCS-ADL as co-primary endpoints. The functional co-primary endpoint, ADCS-ADL, was trending positive but did not reach significance at Week 48. A possible explanation is that the ADCS-ADL scale is designed for AD with overt dementia and is less sensitive for early AD.[2] The prespecified key secondary composite endpoint CDR-SB, also recommended as an alternative primary endpoint for early AD in the new FDA guidance, is significant at both 30 mg and 50 mg at Week 48. The findings are supported by biomarkers from the A/T/N spectrum, including plasma Aß42/40-ratio and reduction of brain atrophy. Blarcamesine significantly slowed brain atrophy in key regions of interest, including the whole brain by 37.6%, total grey matter by 63.5%, and lateral ventricles by 25.1%.
“These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” said Dr. Sabbagh. “The advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and good comparative safety profile. The neuroimaging evaluation performed in the Phase IIb/III study demonstrated no neurological tissue damage such as hemorrhage or Amyloid-related imaging abnormalities (ARIA), as documented with other anti-amyloid targeted therapies. We believe the scalable and convenient features of blarcamesine could reduce crucial barriers within the currently complex healthcare ecosystem for Alzheimer's disease and provide broader access to a diverse population with early Alzheimer's disease.”
Blarcamesine, a small molecule administered orally once daily, demonstrated numerically superior clinical efficacy to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine’s safety profile indicates not requiring routine MRI monitoring, and given its differentiated mechanism of action, could represent a novel treatment that could be complementary to the currently approved anti-beta amyloid monoclonal antibody drugs.
Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex commented: “Anavex's precision medicine approach, tailored to improving autophagy, a key clearance mechanism that removes protein aggregates and misfolded proteins across the Alzheimer's disease continuum and uniquely positions the Company to develop innovative solutions for patients and their families.” He continued: “People living with early Alzheimer's disease have the desire to maintain their sense of self for as long as possible. The study results provide the potential for people with more time to engage in meaningful activities. Full regulatory submission of blarcamesine in Europe (EMA) is expected in Q4 2024.”
For the primary endpoint ADAS-Cog13, blarcamesine is significantly better than placebo for both 50 mg (-2.149; P = 0.021) at 48 weeks and for 30 mg blarcamesine dosage groups (-1.934; P = 0.026) at 48 weeks. The key secondary endpoint CDR-SB was significantly improved vs. placebo in both 50 mg (-0.465; P = 0.045) and 30 mg (-0.502; P = 0.020) assigned dose groups. CGI-I was significantly improved in both 50 mg (-0.314; P = 0.008) and 30 mg (-0.248; P = 0.024) groups.
In the respective safety population, common treatment-emergent adverse events included dizziness, which was transient and mostly mild to moderate in severity, and occurred in 120 participants (35.8%) during titration and in 76 participants (25.2%) during maintenance with blarcamesine and 10 (6.0%) during titration and 9 (5.6%) during maintenance with placebo. These events are manageable by adjusting titration schedule to slower titration and nighttime dosing, as has been positively observed in the blarcamesine compassionate use program.
“Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide. The findings from this and previous studies with blarcamesine in Alzheimer’s disease further strengthen our belief in the potential of addressing the complex pathology in Alzheimer’s disease through an upstream precision medicine compensatory process, autophagy through SIGMAR1 activation,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We like to thank all the people involved in the study for their invaluable contributions and we look forward to continuing our journey to address the high unmet need for Alzheimer’s disease patients with a potential new convenient orally available treatment option for Alzheimer’s disease.”
The presentation is available on the Investors section of the Company’s website at www.anavex.com.
Data from the blarcamesine Phase IIb/III ANAVEX®2-73-AD-004 trial to be published in an upcoming peer-reviewed journal.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
Total annual savings for healthcare? Probably looking at tens of billions.
🏁🏁🏁 https://www.anavex.com/sigmaceptor-explained 🏁🏁🏁
Going to be a lot of receptive and responsive patients positively affected after the EMA approval. 🧠💡
Seems like this could also be said of Adam Feuerstain!
Shorty workin’ harrrrrrd before the onset of presentations, earnings, and eventual EMA approval. Can they escape?
AAIC…two weeks… 🤞
Current Issues in Molecular Biology is a peer-reviewed open access scientific journal publishing review articles and minireviews in all areas of molecular biology and molecular microbiology.
Market is open tomorrow. Will shorty be bailing out?
EMA vs. FDA
https://pharmaphorum.com/views-and-analysis/when-measuring-european-regulatory-approval-the-timestamp-matters
https://www.fda.gov/media/156611/download
https://pharmanewsintel.com/features/regulating-and-authorizing-medicines-a-comparison-of-the-fda-and-ema
https://www.mabion.eu/science-hub/articles/similar-but-not-the-same-an-in-depth-look-at-the-differences-between-ema-and-fda/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6983504/
https://premierconsulting.com/wp-content/uploads/2022/10/Premier-Consulting-Guide_Regulatory-Considerations-for-FDA-vs-EMA.pdf
https://ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.1575
IMHO… “when”, not “if”
https://investorshub.advfn.com/boards/profile.aspx?user=837525&page=1
Your alias was born last year and the majority of your posts appear fixated on George?
Got a crush, or just prone to infatuation?
Put some useful information into the mix. Constant bashing is not constructive contribution.
I’ll take an exuberant, cheerleading George over a glowering misanthrope any day.
MannKind to Establish Boston-Area Research & Development Foothold and Expand Portfolio of Dry Powder Inhalation Technology in Transaction With Pulmatrix
05/29/24
Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D space
Non-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind’s Cricket® inhaler
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has agreed to in-license iSPERSE™ technology from Pulmatrix for certain indications in exchange for an out-license of MannKind’s Cricket® inhaler to Pulmatrix for inhaled delivery of dihydroergotamine (DHE) for migraine treatment. The two companies also agreed that Pulmatrix will transfer its Bedford, Mass. R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.
“We are delighted to grow our Boston-area presence as we continue to progress our pipeline efforts, and in particular, our expanding orphan lung programs,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We have formulated two FDA-approved products utilizing our proven Technosphere® dry powder technology, and this agreement affords us access to another option for future development opportunities.”
“Our Technosphere technology, which is a unique carrier-based, dry powder inhalation platform used in tandem with our proprietary inhaler, provides deep and effective penetration of lung tissue that is well suited for many active ingredients,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”
The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases.
MannKind expects to consolidate its Boston presence by transitioning its Marlborough staff into the newly renovated, fully outfitted R&D facility in Bedford. To maintain continuity of iSPERSE platform knowledge, MannKind plans to hire some members of current Pulmatrix R&D staff.
The agreement is anticipated to close in July 2024.
06/05/24
17-week endpoint results comparing Afrezza® head-to-head with multiple daily injections (MDI) and insulin pumps
INHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced that the 17-week endpoint results from the INHALE-3 study will be presented during a 90-minute symposium and livestream on Saturday, June 22, at the American Diabetes Association’s (ADA) 84th Scientific Sessions. The presentation will be delivered by INHALE-3 Study Protocol Chair Dr. Irl B. Hirsh and the investigational team and will be moderated by Jaeb Center founder Dr. Roy W. Beck.
“We are excited for the first read-out of results from the largest post-market clinical trial MannKind has conducted with Afrezza in the last 10 years,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “The results will speak to the common question about Afrezza: ‘How does inhaled insulin fare when compared head-to-head with usual care?’ The full 30-week results of INHALE-3 will be available later this year.”
Title:
The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Injections in Adults with Type 1 Diabetes
Date: Saturday, June 22, 2024
Times: 8:00-9:30 AM (ET) with topics/presenters to include:
Inhaled Insulin’s History and Study Rationale – Dr. Halis Akturk
Study Methods & Participant Baseline Characteristics – Dr. Yogish Kudva
Study Results I: Comparison of Inhaled Insulin vs. Rapid Acting Analogue Insulin in Users of AID or
MDI During Standardized In-Clinic Meal Challenge –Dr. Ruth S. Weinstock
Study Results II: Primary Efficacy, Safety, and Quality of Life Outcomes – Dr. Carol J. Levy
Study Results III: Effect of Inhaled Insulin-Degludec Compared with AID and in Subgroups According
to Participant Characteristics – Dr. Grazia Aleppo
Critique of Study Design and Results – by Dr. Irl B. Hirsch
Use of Afrezza in Clinical Practice – by Dr. Thomas Blevins
Question and Answer Session – Moderated by Dr. Roy W. Beck
Location: W320 Chapin Theatre at the Orange County Convention Center (+livestream)
Livestream:
Please refer to https://professional.diabetes.org/scientific-sessions for access details
MannKind will host booth# 1307 in the Exhibit Hall throughout the Scientific Sessions as well. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.
“Congress has passed the first-ever federal bill dedicated to ending Parkinson’s! This historic legislation now heads to President Biden’s desk thanks to the tireless efforts of tens of thousands of policy advocates, champions in Congress, partner organizations and many others. We stand ready to work together to bring the promise of the National Plan to fruition on behalf of everyone touched by Parkinson’s and atypical parkinsonisms.” https://www.michaeljfox.org/
April 30, 2024 8:00 AM EDT
Lineage Receives Grant From California Institute for Regenerative Medicine (CIRM)
Award Will Support 2nd Annual Spinal Cord Injury Investor Symposium To Be Held June 26 and 27, 2024
CARLSBAD, Calif.--(BUSINESS WIRE)--Apr. 30, 2024-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the Company has received an Education Conference II Grant from the California Institute for Regenerative Medicine (CIRM), to support the 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS builds upon a successful inaugural event held in 2023 and will connect a diverse set of stakeholders in the field of spinal cord injury (SCI). This year’s event aims to accelerate development in SCI research and treatments by bringing together companies working in the development of treatments for SCI, with regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations and the investment community, in order to discuss perspectives on current and future treatment alternatives, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and broaden awareness of and investment of capital into SCI.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240430502008/en/
https://www.yahoo.com/lifestyle/signs-of-multiple-sclerosis-can-be-detected-in-blood-5-years-before-symptoms-appear-new-study-finds-heres-why-this-breakthrough-is-important-090015569.html
Early detection + early treatment = positive and prolonged life experiences.
https://www.yahoo.com/gma/paralyzed-man-walk-again-shows-195027431.html
I think LINEAGE is on the correct path to success.
https://www.physiciansweekly.com/biomarkers-of-alzheimers-disease-detected-as-early-as-18-years-prior-to-diagnosis/
Early detection + early treatment = positive outcomes.
“ANAVEX 2-73 (blarcamesine) and pipeline targets novel mechanism of action further "upstream" of the Alzheimer's disease pathology by targeting Sigma-1 receptor and muscarinic receptors, which is believed to increase cellular plasticity and reduce oxidative stress, inflammation, abeta generation and tau hyperphosphorylation. All these effects are believed to be relevant to reduce Alzheimer's disease pathology.”
Awaiting the EMA announcement. 🏆
Additionally…
https://www.yahoo.com/finance/news/orchard-follows-buyout-fda-approval-111600290.html
Anavex has a potent potential pipeline that would be economically accessible, rather than being celestially priced.