A Phase 2, Parallel Group, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared with Placebo in Patients with Early Alzheimer’s Disease - 219867

Start Date07 May 2024

Sponsor / Collaborator

GlaxoSmithKline Research & Development Ltd.

NCT06079190 / RecruitingPhase 2

A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Start Date20 Oct 2023

Sponsor / Collaborator

GSK Plc

[+1]

NCT04111666 / CompletedPhase 1

A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101

A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

Start Date14 Dec 2019

Sponsor / Collaborator

Alector, Inc.

100 Clinical Results associated with Nivisnebart

100 Translational Medicine associated with Nivisnebart

100 Patents (Medical) associated with Nivisnebart

Literatures (Medical) associated with Nivisnebart

01 Jul 2022·Contact DermatitisQ2 · MEDICINE

Gene profiling reveals a contact allergy signature in most positive Amerchol L‐101 patch test reactions

Q2 · MEDICINE

Article

Author: Nourikyan, Julien ; De Bernard, Simon ; Bruze, Magnus ; Ljungberg Silic, Linda ; Nosbaum, Audrey ; Lefevre, Marine‐Alexia ; Nicolas, Jean‐François ; Bergendorff, Ola ; Svedman, Cecilia ; Buffat, Laurent ; Vocanson, Marc

AbstractBackgroundDiagnosis of contact allergy (CA) to Amerchol L‐101 (AL‐101), a marker for lanolin allergy, is problematic. Positive patch test reactions are frequently doubtful or weakly positive and difficult to associate with clinical relevance.ObjectiveTo gain further insight on the allergic or irritant nature of skin reactions induced by AL‐101 patch test.MethodsWe re‐tested in a dose–response fashion, 10 subjects with AL‐101 CA and performed comprehensive transcriptomic analysis (gene arrays, quantitative real‐time polymerase chain reaction [qRT‐PCR]) of samples of their skin reactions.ResultsEight of the 10 CA subjects reacted positively upon re‐test, whereas two did not react. Most of AL‐101 positive patch tests expressed an allergy signature with strong activation of gene modules associated with adaptive immunity and downregulation of cornification pathway genes. In addition, the breadth of gene modulation correlated with the magnitude of patch test reactions and the concentration of AL‐101 applied. However, we observed that some of the positive patch test reactions to AL‐101 expressed no/few allergy biomarkers, suggesting the induction of an irritant skin inflammation in these samples.ConclusionsThis study confirms that AL‐101 is an allergen that can cause both contact allergy and contact irritation. Our results also highlight that molecular profiling might help to strengthen clinical diagnosis.

01 Sep 2018·Photodiagnosis and Photodynamic Therapy

Antimicrobial photodynamic therapy assessment of three indocyanine green-loaded metal-organic frameworks against Enterococcus faecalis

Article

Author: Pourhajibagher, Maryam ; Khoobi, Mehdi ; Bahramian, Bahram ; Barikani, Hamid Reza ; Bahador, Abbas ; Golmohamadpour, Azadeh

BACKGROUNDAntimicrobial photodynamic therapy (aPDT) has emerged as one of the promising non-invasive adjuvant treatments of endodontic infections. The key part of this technique is application of an optimized nontoxic photosensitizer (PS), like indocyanine green (ICG) which when activated by light can destroy bacterial contaminants. Notwithstanding all featured properties of ICG, this PS mainly suffers from the lack of stability and concentration-dependent aggregation. A variety of nanomaterials (NMs) has been widely exploited to improve the stability and efficiency of ICG. The objective of this study was to evaluate and compare the efficiency of three high capacious metal organic frameworks (MOFs) to produce MOF-ICG as novel PSs improving ICG loading, stability and antimicrobial activity. This is first report on ICG-loaded MOFs for aPDT against endodontic infections.MATERIALS AND METHODSThree different nano-MOFs were synthesized (denoted as Fe-101, Al-101 and Fe-88), and employed for ICG loading (MOF-ICG). The stability of immobilized ICG, antimicrobial and anti-biofilm properties of MOF-ICG against Enterococcus faecalis (E. faecalis) as one of the main factors of endodontic infections as well as expression ratio of the esp gene in E. faecalis were evaluated.RESULTSFe-101 and Al-101 showed acceptable ICG loading (ICG loading capacity of 16.93 ± 0.32 and 18.17 ± 0.31, respectively) as well as considerable enhanced aqueous stability (percent of degradation were only 14% and 17%, respectively) in comparison to free ICG (percent of degradation was 95%) after 10 days. ICG-free MOFs could surprisingly suppress the viability of E. faecalis after laser irradiation up to 18.1%, 28.8%, and 38.3% for Al-101, Fe-88 and Fe-101, respectively. ICG loaded MOFs mediated aPDT could significantly reduce the count of E. faecalis to 60.72%, 45.12%, and 62.67%, respectively (p < 0.05). The Fe-88-ICG-PDT, Fe-101-ICG-PDT and Al-101-ICG-PDT considerably dropped the biofilm formation of E. faecalis by 37.54%, 47.01% and 53.68% (p < 0.05). The expression of esp gene was also remarkably declined to 4.4-, 6.0- and 6.2-fold after aPDT in the presence of Fe-88-ICG, Al-101-ICG and Fe-101-ICG, respectively (P < 0.05).CONCLUSIONOwing to the significant features of the Fe-101 including acceptable ICG loading and stability, as well as reasonable antimicrobial effect after ICG loading in comparison to free ICG, it could be considered as a promising nano-PSs in aPDT to remove E. faecalis.

01 Dec 2011·Malaria JournalQ3 · MEDICINE

Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children

Q3 · MEDICINE

ArticleOA

Author: David Ubben ; Mike Chaponda ; Sebastian Hachizovu ; Michael Nambozi ; Jean-Pierre Van Geertruyden ; Modest Mulenga ; Umberto D'Alessandro ; Doreen Mukwamataba

BACKGROUNDMalaria in Zambia remains a public health and developmental challenge, affecting mostly children under five and pregnant women. In 2002, the first-line treatment for uncomplicated malaria was changed to artemether-lumefantrine (AL) that has proved to be highly efficacious against multidrug resistant Plasmodium falciparum.OBJECTIVEThe study objective was to determine whether dihydroartemisinin-piperaquine (DHA/PQP) had similar efficacy, safety and tolerability as AL for the treatment of children with uncomplicated P. falciparum malaria in Ndola, Zambia.METHODSBetween 2005 and 2006, 304 children (6-59 months old) with uncomplicated P. falciparum were enrolled, randomized to AL (101) or DHA/PQP (203) and followed up for 42 days. Outcome of treatment was defined according to the standard WHO classification, i.e. early treatment failure (ETF), late clinical failure (LCF, late parasitological failure (LPF) and adequate clinical and parasitological response (ACPR). Recurrent infections were genotyped to distinguish between recrudescence and new infection.RESULTSNo ETF was observed. At day 28, PCR-uncorrected ACPR was 92% in the DHA/PQP and 74% in the AL arm (OR: 4.05; 95%CI: 1.89-8.74; p < 0.001). Most failure were new infections and PCR-corrected ACPR was similar in the two study arms (OR: 0.69; 95%CI: 0.22-2.26; p = 0.33). Similar results were observed for day 42, i.e. higher PCR-uncorrected ACPR for DHA/PQP, mainly due to the difference observed up to day 28, while the PCR-corrected ACPR was similar: DHA/PQP: 93% (179/192), AL: 93% (84/90), (OR: 0.92; 95%CI: 0.30-2.64; p = 0.85). Except for cough, more frequent in the DHA/PQP arm (p = 0.04), there were no differences between treatment arms in the occurrence of adverse events. Two serious adverse events were probably associated to AL treatment.CONCLUSIONDHA/PQP was as efficacious, safe and well tolerated in treatment of uncomplicated malaria as AL, though in the latter group more new infections during the follow up were observed. DHA/PQP seems a potential candidate to be used as an alternative first-line or rescue treatment in Zambia.TRIAL REGISTRATIONISRCTN16263443, at http://www.controlled-trials.com/isrctn.

News (Medical) associated with Nivisnebart

12 Nov 2024

·endpts.com

GSK snags Parkinson's drug from Flagship startup Vesalius

GSK has licensed a small molecule for Parkinson’s and is teaming up on additional targets for the disease and another undisclosed neurodegenerative condition with Flagship-founded Vesalius Therapeutics. The UK pharma will make an $80 million cash and equity investment, and could pay as much as $570 million more in milestones or other payments, the companies said Tuesday morning. Tiered royalties could also come Vesalius’ way for the Parkinson’s small molecule, which is in the preclinical stages and could be tested in additional areas down the road. GSK’s pipeline includes a few CNS projects, including latozinemab in Phase 3 for certain forms of frontotemporal dementia, and GSK4527226 in Phase 2 for Alzheimer’s disease. Last quarter, it postponed development of latozinemab for ALS and a different type of frontotemporal dementia. Kaivan Khavandi, GSK’s global lead on respiratory and immunology R&D, said in a statement that Vesalius’ platform will help the company hone in on the “root causes of disease.” Like many biotech startups, Vesalius uses artificial intelligence to help determine which targets to go after. It employs large-scale human genetics, genomics, patient data and induced pluripotent stem cell models to figure out which patient populations are “most likely to respond within a common disease,” Vesalius interim CEO John Mendlein told Endpoints News. The company was founded in 2019 and announced a $75 million Series A in March 2022, with an ambitious mission to revolutionize the treatment of common diseases that drive 90% of human illnesses. About six months after its financing, Vesalius laid off about 40% of its workforce. The company has “just shy of 30 people” today, Mendlein said. Vesalius recently raised additional money, Mendlein said, declining to share more details. “Common diseases are often lumped together. How many different forms of diabetes could there be, or obesity?” Mendlein said. Studies of new treatments for common diseases can also be “quite expensive to run,” Mendlein said. By taking a precision medicine approach, it believes it can increase its chances of success. Neuro, immunology and metabolic diseases are some of Vesalius’ areas of interest, he said. “Using this type of methodology, where you have more certainty around the causation associated with the therapeutic intervention point and a particular disease manifestation, perhaps we can bubble up our probability of success, maybe 15%,” Mendlein said, “which would be a vast improvement compared to where we are today.” Mendlein, who is also an executive partner at Flagship Pioneering and has been involved in many of the incubator’s offshoots , will likely hand off the CEO role soon, as the company is searching for a permanent leader. “I love the company and the science behind the company, and what we’ve been able to do so far. And the best is yet to come,” Mendlein said. “But I like parallel entrepreneurship.”

Phase 2Phase 3

06 Nov 2024

·www.globenewswire.com

ONCOTELIC CLINICAL PRESENTATIONS AT SITC 2024

AGOURA HILLS, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its presentation at SITC 2024. Dr. Cynthia Lee, VP of R&D will be presenting Sapu Bio pipeline of TGFB2 therapeutics. For additional information please go to: https://www.sitcancer.org/home. Dr. Lee has been leading our R&D programs for the past several years including the buildout of our GMP facility in San Diego. The presentations are: Abstract Number 198: TGFB2 mRNA levels prognostically interact with Interferon-alpha receptor activation of IRF9 and IFI27, and makers for tumor-associated macrophages impacting overall survival in PDAC. Authors Sanjive Qazi, Cynthia Lee, Vuong Trieu Abstract Number 218: Evaluating the prognostic impact of Transforming growth factor beta 2 mRNA levels, in conjunction with Interferon-gamma receptor activation of IRF5 and expression of CD276/B7-H3 in low-grade gliomas. Authors Sanjive Qazi, Anthony Maida, Vuong Trieu Abstract Number 1444: Meta-analysis comparing the incidence of serious adverse events, overall survival, and progression-free survival in PDAC patients harboring unresectable tumors treated with mFOLFIRINOX or FOLFIRINOX. Authors Vuong Trieu, Sanjive Qazi, Seymour Fein, Anthony Maida, Tenshang Joh About Oncotelic Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (through OXi 4503). Oncotelic acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. Oncotelic’s first in class TGFB2 therapeutic to treat pancreatic cancer and glioblastoma is being developed through its JV – Sapu Bio. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the development of the Company’s AI suite including but not limited to AI Chatbots, the public access to the Company’s AI suite, the success of the development of the AI suite or any other AI technologies and whether if any or portion thereof the Company’s AI suite or technologies will be commercialized and launched for sale. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's Annual Report on Form 10-K/A filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

AcquisitionmRNA

28 Oct 2024

·www.globenewswire.com

ONCOTELIC PUBLISHED ITS FOURTH PUBLICATION ON TGFB2 THERAPEUTICS

AGOURA HILLS, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its fourth publication of its TGFB2 series. Clinical data demonstrated that pancreatic cancer patients with high expression levels of either TGFB2, IRF9, or IFI27 showed improvement of median overall survival from 16-20 months to 72 months for patients with low levels of expression for both TGFB2 and either IRF9 or IFI27 validating that knockdown of IRF9 and IFI27 as therapeutic targets for TGFB2 therapeutics. https://www.mdpi.com/3003472 The publications of this series are available at Pubmed as follow: 1) TGFB2 mRNA Levels Prognostically Interact with Interferon-Alpha Receptor Activation of IRF9 and IFI27, and an Immune Checkpoint LGALS9 to Impact Overall Survival in Pancreatic Ductal Adenocarcinoma. Qazi S, Trieu V. Int J Mol Sci. 2024 Oct 18;25(20):11221. doi: 10.3390/ijms252011221. PMID: 39457004 2) Transforming Growth Factor Beta 2 (TGFB2) mRNA Levels, in Conjunction with Interferon-Gamma Receptor Activation of Interferon Regulatory Factor 5 (IRF5) and Expression of CD276/B7-H3, Are Therapeutically Targetable Negative Prognostic Markers in Low-Grade Gliomas. Trieu V, Maida AE, Qazi S. Cancers (Basel). 2024 Mar 19;16(6):1202. doi: 10.3390/cancers16061202. PMID: 38539537 Free PMC article. 3) Transforming Growth Factor Beta 2 (TGFB2) and Interferon Gamma Receptor 2 (IFNGR2) mRNA Levels in the Brainstem Tumor Microenvironment (TME) Significantly Impact Overall Survival in Pediatric DMG Patients. Qazi S, Talebi Z, Trieu V. Biomedicines. 2024 Jan 15;12(1):191. doi: 10.3390/biomedicines12010191. PMID: 38255296 Free PMC article. 4) High Intra-Tumor Transforming Growth Factor Beta 2 Level as a Predictor of Poor Treatment Outcomes in Pediatric Diffuse Intrinsic Pontine Glioma. Uckun FM, Qazi S, Trieu V. Cancers (Basel). 2023 Mar 9;15(6):1676. doi: 10.3390/cancers15061676. PMID: 36980562 Free PMC article. Additional information on our current phase 3 can be found at: https://www.youtube.com/watch?v=5KqdbySDRKE About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (through OXi 4503). Oncotelic acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our Annual Report on Form 10-K/A filed with the SEC on April 19, 2023. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the development of the Company’s AI suite including but not limited to AI Chatbots, the public access to the Company’s AI suite, the success of the development of the AI suite or any other AI technologies and whether if any or portion thereof the Company’s AI suite or technologies will be commercialized and launched for sale. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's Annual Report on Form 10-K/A filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

AcquisitionPhase 3

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	DE	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	TR	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	US	GSK Plc	20 Oct 2023
Alzheimer Disease	Phase 2	NO	GSK Plc	20 Oct 2023
Alzheimer Disease	Phase 2	NL	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	KR	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	GB	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	AU	GSK Plc	20 Oct 2023
Alzheimer Disease	Phase 2	FR	Alector, Inc.	20 Oct 2023
Alzheimer Disease	Phase 2	US	Alector, Inc.	20 Oct 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACCURACY (ESMO2023)	Phase 2	-	-	AL101 4 mg	(smhoxahyzo) = eauyxeaudp hiqwowhpnz (clnfqxtmtf )	-	22 Oct 2023
				AL101 6 mg	(smhoxahyzo) = aevakutbrd hiqwowhpnz (clnfqxtmtf )

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