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Preclinical Efficacy Data Articles & Analysis

151 news found

Proregulations Launches Comprehensive ANDA Services   

Proregulations Launches Comprehensive ANDA Services  

FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but rather requires the inclusion of ...

ByProregulations


CanaQuest and Neeka Health Sign Agreement to Conduct Clinical Studies with Mentanine

CanaQuest and Neeka Health Sign Agreement to Conduct Clinical Studies with Mentanine

The Neeka team has completed extensive due diligence on our science, preclinical data package, and our proprietary formulations prior to selecting CanaQuest as their cannabinoid partner for clinical studies and we are looking forward to a long-standing relationship and continuing to put science at the forefront of our company,” said Paul Ramsay, President ...

ByCanaQuest Medical Corp.


Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting

Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting

In the New Drugs on the Horizon session at AACR, Bayer will present preclinical data on its novel selective diacylglycerol kinase (DGK) zeta inhibitor BAY 2965501, which is under Phase 1 clinical evaluation. ...

ByBayer AG


First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

Biolojic uses its proprietary AI platform to design antibodies with new capabilities to cure disease, ushering in a new era of smart therapeutics Biolojic Tel Aviv to focus on computational design of antibodies; Boston location will focus on drug development Biolojic Design, a unique technology company pioneering computational design of human antibodies to develop smart therapeutic ...

ByBiolojic Design, Ltd.


Leucine-Enkephalin as a Novel Analgesic: Efficacy and Safety in Pre-Clinical Models

Leucine-Enkephalin as a Novel Analgesic: Efficacy and Safety in Pre-Clinical Models

Endogenous peptides with analgesic potential include endorphins via the mu receptor, dynorphins via the kappa receptor and enkephalins via the delta receptor. Kappa and delta opioid agonists have been shown to provide analgesic benefit while sparing toxic mu agonist toxicity1 . Preclinical data supports analgesia from enkephalin without significant opioid tolerance, or drug liking. Unfortunately, ...

ByVirpax Pharmaceuticals


ViGeneron presents preclinical data on intravitreal gene therapy of Stargardt disease at ESGCT

ViGeneron presents preclinical data on intravitreal gene therapy of Stargardt disease at ESGCT

Efficient transfer of larger gene via ViGeneron’s proprietary technology platforms REVeRT and vgAAV ViGeneron advances its preclinical programs for Stargardt disease and Retinitis Pigmentosa into IND-enabling activities and clinical stage development ViGeneron GmbH, a next-generation gene therapy company, today announced the presentation of ...

ByViGeneron GmbH


Beyond Cancer Announces Sponsored Research Agreement with Stanford and Appointment of Frederick M. Dirbas, MD and Mark D. Pegram, MD to Scientific Advisory Board

Beyond Cancer Announces Sponsored Research Agreement with Stanford and Appointment of Frederick M. Dirbas, MD and Mark D. Pegram, MD to Scientific Advisory Board

Dirbas will serve as Chair of the SAB, which provides guidance for ongoing preclinical studies as well as ongoing and planned future clinical trials in the use of UNO to treat solid tumors. ...

ByBeyond Air Inc


Combines mesenchymal stem-cell-based product, with Kurve’s intranasal drug delivery technology

Combines mesenchymal stem-cell-based product, with Kurve’s intranasal drug delivery technology

(NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and Kurve Therapeutics, a next-generation medtech and drug formulation company, today announced positive preclinical study results for intranasal administration of a cell-based oncolytic virus bearing product. ...

ByKurve Therapeutics, Inc.


LIXTE Biotechnology Announces the Closing of $5.8 Million Registered Direct Offering Priced At-The-Market

LIXTE Biotechnology Announces the Closing of $5.8 Million Registered Direct Offering Priced At-The-Market

LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced that it has closed a registered direct offering with certain institutional and accredited investors for $5.8 million of common stock. The Company issued a total of 2,900,000 shares of common stock at a purchase price of ...

ByLIXTE Biotechnology Holdings, Inc.


Beyond Cancer Publishes Pre-Clinical Data in Cancer Cell International Demonstrating Its Tumor Ablation Method Utilizing Ultra-High Concentration Nitric Oxide (UNO) Induced a Systemic Response that Prevents Metastases

Beyond Cancer Publishes Pre-Clinical Data in Cancer Cell International Demonstrating Its Tumor Ablation Method Utilizing Ultra-High Concentration Nitric Oxide (UNO) Induced a Systemic Response that Prevents Metastases

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is focused on developing ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, announced today the publication of pre-clinical data demonstrating that its proprietary tumor ablation technology utilizing UNO results in a potent innate and adaptive immune response that prevents metastases and resulted ...

ByBeyond Air Inc


Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer

Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer

PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, ...

ByContext Therapeutics Inc.


Oligomerix Presents Data from IND-Enabling Studies on Clinical Candidate at Clinical Trials on Alzheimer’s Disease (CTAD) and Neuroscience 2022 Meetings

Oligomerix Presents Data from IND-Enabling Studies on Clinical Candidate at Clinical Trials on Alzheimer’s Disease (CTAD) and Neuroscience 2022 Meetings

Oligomerix, Inc., a privately held company pioneering the development of small molecule therapeutics targeting tau for rare neurodegenerative and Alzheimer’s diseases, today announced the presentation of IND-enabling preclinical data on its lead product candidate OLX-07010 at the annual Clinical Trials on Alzheimer's Disease (CTAD) and Society for ...

ByOligomerix, Inc.


LIXTE Biotechnology Holdings to Present at Planet MicroCap Showcase: VIRTUAL 2022 Investor Conference

LIXTE Biotechnology Holdings to Present at Planet MicroCap Showcase: VIRTUAL 2022 Investor Conference

LIXTE Biotechnology Holdings, Inc. (Nasdaq:LIXT) today announced it will be presenting at the Planet MicroCap Showcase: VIRTUAL 2022 investor conference Wednesday, December 7, 2022 at 3:30 p.m. EST/12:30 p.m. PST. John S. Kovach, M.D., founder and CEO of LIXTE, will host the presentation. Dr. Kovach, with his team, will be answering questions at the conclusion. To access the presentation, ...

ByLIXTE Biotechnology Holdings, Inc.


Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). The Phase 2 trial of INV-202, a first-in-class, peripherally-acting CB1 inverse agonist, is a ...

ByInversago Pharma


Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Moreover, none are currently FDA approved for endometrial cancer, creating an urgent need for improved treatment options for LGEEC patients. Clinical and preclinical data suggest narazaciclib’s differentiated inhibitory profile may allow it to address this unmet need, which is a hypothesis I look forward to evaluating with my colleagues in Onconova’s ...

ByTraws Pharma


Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

Beyond Air, Inc. (NASDAQ: XAIR) a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced ...

ByBeyond Air Inc


ITM Executes Option to In-license Targeted Radionuclide Therapy Candidate LuCaFab (ITM-31) for the Treatment of Malignant Brain Tumors

ITM Executes Option to In-license Targeted Radionuclide Therapy Candidate LuCaFab (ITM-31) for the Treatment of Malignant Brain Tumors

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the execution of an exclusive licensing option for LuCaFab (now ITM-31), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma. ITM-31 is a carbonic anhydrase XII (CA XII)-specific antibody Fab fragment developed by Helmholtz Munich and coupled with ITM's ...

ByITM Isotope Technologies Munich SE


Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

IO-108 is being studied as a monotherapy and in combination with select anti-PD-1 antibodies in multiple expansion cohorts of solid tumors Clinical supply agreement with Regeneron accelerates Immune-Onc’s solid tumor clinical development program Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel ...

ByImmune-Onc Therapeutics, Inc.


PharmAbcine Announces Poster Presentations on Its anti-VISTA Antibody Candidate at SITC 2022

PharmAbcine Announces Poster Presentations on Its anti-VISTA Antibody Candidate at SITC 2022

PharmAbcine Announces Poster Presentations on Its anti-VISTA Antibody Candidate at SITC 2022 DAEJEON, South Korea, October 17, 2022 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, announced today that the Company will present preclinical data of PMC-309, one of the Company’s first immuno-oncology ...

ByPharmAbcine Inc.


Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

Additionally, early signals of clinical activity were observed in multiple tumor types with demonstrated monotherapy efficacy. This supports the clinical development plan to advance IO-108 into select cancers for dose expansion as monotherapy and in combination with anti-PD-(L)1 and/or standard of care therapies. ...

ByImmune-Onc Therapeutics, Inc.

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