- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Trial completion, Trial completion date, Trial primary completion date: GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Oct 23, 2024
P2, N=78, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Nov 2025 Recruiting --> Completed | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
- |||||||||| Leqembi (lecanemab-irmb) / Biogen, BioArctic, Eisai
P3 data, Journal: Beyond lecanemab: Examining Phase III potential in Alzheimer's therapeutics. (Pubmed Central) - Jun 13, 2024
However, Gantenerumab and Solanezumab, unsuccessful in Phase III, are not covered. While the future approval status remains uncertain, we hope these drugs will offer beneficial therapeutic effects for potential dementia patients.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Trial primary completion date: GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - Apr 14, 2024
P2, N=180, Active, not recruiting,
While the future approval status remains uncertain, we hope these drugs will offer beneficial therapeutic effects for potential dementia patients. Trial primary completion date: Sep 2025 --> Apr 2025
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Enrollment closed, Trial completion date, Trial primary completion date: GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - Mar 12, 2024
P2, N=180, Active, not recruiting,
Trial primary completion date: Sep 2025 --> Apr 2025 Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Mar 2026 | Trial primary completion date: Jul 2023 --> Sep 2025
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Preclinical, Journal: GV1001 reduces neurodegeneration and prolongs lifespan in 3xTg-AD mouse model through anti-aging effects. (Pubmed Central) - Feb 22, 2024
levels, neurodegeneration (i.e., reduced CA1, CA3 and dentate gyrus volume, decreased levels of senescence-associated ?-galactosidase positive cells, and increased telomere length and telomerase activity), and levels of ageing-associated proteins. We suggest that GV1001 exerts anti-ageing effects in 3xTg-AD mice by reducing neurodegeneration and senescence, which contributes to improved survival.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Trial completion date, Trial primary completion date: GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD) (clinicaltrials.gov) - Jan 16, 2024
P3, N=750, Not yet recruiting,
We suggest that GV1001 exerts anti-ageing effects in 3xTg-AD mice by reducing neurodegeneration and senescence, which contributes to improved survival. Trial completion date: Apr 2027 --> Jun 2028 | Trial primary completion date: Oct 2026 --> Dec 2027
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Biomarker, Review, Journal: Exploring the Enigma of 5-ARIs Resistance in Benign Prostatic Hyperplasia: Paving the Path for Personalized Medicine. (Pubmed Central) - Dec 25, 2023
Additionally, on the horizon, GV1001 and mTOR inhibitors have emerged as potential alternative therapeutic modalities for addressing BPH in the future...The imperative for early identification of individuals prone to treatment resistance will drive physicians to proactively stratify risk and adapt treatment tactics in future practice. This personalized medicine approach marks a progression from the current standard treatment model, emerging as the future trajectory in BPH management.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD) (clinicaltrials.gov) - Sep 18, 2023
P3, N=0, Withdrawn,
Not yet recruiting --> Recruiting N=936 --> 0 | Trial completion date: Apr 2026 --> Apr 2027 | Not yet recruiting --> Withdrawn | Trial primary completion date: Oct 2025 --> Oct 2026
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Enrollment open, Trial initiation date: GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - Nov 23, 2022
P2, N=180, Recruiting,
Therefore, DS-2 might be used as a novel therapeutic drug for cancer immunotherapy by targeting hTERT in prostate cancer. Not yet recruiting --> Recruiting | Initiation date: May 2022 --> Oct 2022
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Journal: A novel telomerase-derived peptide GV1001-mediated inhibition of angiogenesis: Regulation of VEGF/VEGFR-2 signaling pathways. (Pubmed Central) - Oct 4, 2022
Furthermore, GV1001 suppresses the proliferation and invasion of non-small cell lung cancer cells, and the release of VEGF from the cells, suggesting the regulatory role of GV1001 in tumor-derived angiogenesis as well as cancer cell growth and progression. Collectively, our study reports the pharmacological potential of GV1001 in the regulation of angiogenesis, and warrants further evaluation and development of GV1001 as a promising therapeutic agent for a variety of angiogenesis-related diseases including cancer.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Trial completion: Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) (clinicaltrials.gov) - Aug 25, 2022
P3, N=423, Completed,
Collectively, our study reports the pharmacological potential of GV1001 in the regulation of angiogenesis, and warrants further evaluation and development of GV1001 as a promising therapeutic agent for a variety of angiogenesis-related diseases including cancer. Active, not recruiting --> Completed
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Enrollment change, Trial withdrawal: GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - Mar 3, 2022
P2a, N=0, Withdrawn,
Although no clear GV1001-specific immune response was observed, the addition of GV1001 vaccination to chemotherapy was tolerable and associated with modest efficacy outcomes. N=90 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Enrollment closed, Trial completion date, Trial primary completion date: Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) (clinicaltrials.gov) - Mar 3, 2022
P3, N=417, Active, not recruiting,
N=90 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Active, not recruiting | Trial completion date: Feb 2021 --> Mar 2022 | Trial primary completion date: Aug 2020 --> Mar 2022
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Journal: The BASHY Platform Enables the Assembly of a Fluorescent Bortezomib-GV1001 Conjugate. (Pubmed Central) - Jan 26, 2022
The accumulation in these hydrophobic organelles limited the hydrolysis of the complex and consequently the drug release, a problem that was circumvented by the conjugation of the BASHY-Btz complex with a cell-penetrating peptide GV1001-C. The conjugate exhibited an improved cytoplasmic availability as confirmed by confocal fluorescence microscopy studies and an improved potency against HT-29 cancer cells (IC = 100 nM) as compared to the nontargeted complex (IC = 450 nM).
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Journal: Anti-metastatic effect of GV1001 on prostate cancer cells; roles of GnRHR-mediated Gαs-cAMP pathway and AR-YAP1 axis. (Pubmed Central) - Nov 10, 2021
The conjugate exhibited an improved cytoplasmic availability as confirmed by confocal fluorescence microscopy studies and an improved potency against HT-29 cancer cells (IC = 100 nM) as compared to the nontargeted complex (IC = 450 nM). Overall, this study reveals an essential role of AR-YAP1 in the regulation of PCa cell migration, and provides evidence that GV1001 could be a novel GnRHR ligand to inhibit metastasis of PCa via the Gαs/cAMP pathway.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Journal: Telomerase Biology Associations offer Keys to Cancer and Aging Therapeutics. (Pubmed Central) - Aug 19, 2021
GV1001, a 16 amino acid peptide of TERT that associates with Heat Shock Proteins (HSP's), bypasses the cell membrane with remarkable anti disease potential...The evolution of "smart drugs" offers the unprecedent ability to target of chemotherapy to only cancer cells. The review overall, argues for appropriate development of therapeutic intervention of telomerase in age related diseases especially in neurology and cardiology.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL, Samsung
Journal: GV1001 interacts with androgen receptor to inhibit prostate cell proliferation in benign prostatic hyperplasia by regulating expression of molecules related to epithelial-mesenchymal transition. (Pubmed Central) - Jul 21, 2021
In addition, GV1001 prevented fibrosis of the prostate by downregulating expression of prostatic epithelial-mesenchymal transition (EMT)-related proteins such as transforming growth factor (TGF)-β, Snail, Slug, N-cadherin, and Vimentin, and by up-regulating E-cadherin. Taken together, these results suggest that GV1001, which suppresses TGF-β-mediated EMT by outcompeting testosterone for binding to AR, is a potential therapeutic drug for BPH accompanied by prostatic fibrosis.
- |||||||||| lamivudine HBV / Generic mfg.
Journal: A Telomerase-Derived Peptide Exerts an Anti-Hepatitis B Virus Effect via Mitochondrial DNA Stress-Dependent Type I Interferon Production. (Pubmed Central) - Apr 2, 2021
GV1001 inhibited HBV replication and hepatitis B surface antigen (HBsAg) secretion in a dose-dependent manner, showing synergistic antiviral effects with nucleos(t)ide analogs (NAs) including entecavir and lamivudine...We demonstrated that the cell-penetrating and cytosolic localization capacity of GV1001 results in antiviral effects on HBV infections via mtDNA stress-mediated IFN-I production. Thus, GV1001, a peptide proven to be safe for human use, may be an anti-HBV drug that can be synergistically used with nucleot(s)ide analog.
- |||||||||| Clinical, Review, Journal, IO biomarker: Telomerase-based cancer therapeutics: a review on their clinical trials. (Pubmed Central) - Jan 1, 2021
Many of these therapeutic tools are under different stages of clinical trials and have shown promising outcomes. In this review, we highlight the current status of telomerase-based cancer therapeutics and the outcome of these investigations.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Preclinical, Journal: A telomerase-derived peptide vaccine inhibits laser-induced choroidal neovascularization in a rat model. (Pubmed Central) - Oct 2, 2020
The present study demonstrates that GV1001 treatment led to significant suppression of laser-induced CNV, alongside inhibition of inflammatory processes including NF-κB activation and subsequent upregulation of proinflammatory cytokines. Therefore, this provides molecular evidence of potential validity of GV1001 treatment as a therapeutic strategy for neovascular age-related macular degeneration.
- |||||||||| LucaVax (tertomotide) / GemVax & KAEL
Trial completion, Trial completion date, Trial primary completion date: Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients (clinicaltrials.gov) - Jul 9, 2020
P2, N=96, Completed,
Therefore, this provides molecular evidence of potential validity of GV1001 treatment as a therapeutic strategy for neovascular age-related macular degeneration. Recruiting --> Completed | Trial completion date: Jun 2019 --> Sep 2019 | Trial primary completion date: Jun 2019 --> Sep 2019
- |||||||||| LucaVax (tertomotide) - KAEL / GemVax
A retrospective observational study of telomerase peptide immunotherapy in heavily treated solid cancer patients (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2591;
The riavex(GV1001) which is 16 amino acid sequences from the telomere combines with HLA classI to induce an immune response through activates the CD4 T cell... , Riavex as a anti-cancer vaccine is relatively safe to heavily treated solid cancer patient and is assessed to improve quality of life, although the treatment response is not promising.
- |||||||||| LucaVax (tertomotide) - KAEL / GemVax
Journal: Anti-cancer effect of GV1001 for prostate cancer; function as a ligand of GnRHR. (Pubmed Central) - May 7, 2020
Moreover, GV1001 significantly inhibited the proliferation and migration of PCa cells and induced apoptosis in a concentration-dependent manner. Our findings suggest that GV1001 functions as a biased GnRHR ligand to selectively stimulate the Gαs/cAMP pathway, with anti-proliferative and anti-migratory effects on human PCa.
- |||||||||| rasagiline / Generic mfg.
[VIRTUAL] ALZHEIMER’S DRUG DEVELOPMENT PIPELINE: NOVEL TARGETS AND INNOVATIVE APPROACHES (Hall E) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_54;
One novel combination approach consists of losartan, amlodipine, atorvastatin and exercise and rasagiline is an example of molecule with pleiotropic effects on dopamine and disease-biology pathways...Novel designs being integrated into AD drug development include basket trials, randomized withdrawal trials, serial parallel comparison designs, and platform trials. Conclusions Progress in development of agents with novel targets and novel approaches will accelerate drug development for AD, clarify the disease-biology, and contribute to the development of treatments and treatment combinations for different phases of AD.
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