Valaciclovir

Candel Therapeutics Announces Positive Interim Data from Randomized Phase 2 Clinical Trial of CAN-2409 in Non-Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, April 4, 2024
Toxicity, B cell, Conditional sentence, SOC, Survival, Survival rate, Chemoradiotherapy, Patient, Neoplasm, Tumor microenvironment, Standard of care, Doctor of Philosophy, Lymphocyte, Pancreatic cancer, Therapy, Cytokine, Injection, Pancreatitis, CD8, SITC, Recurrence, Valaciclovir, FDA, Annual general meeting, CADL, Food, Pharmaceutical industry

At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation.

Key Points: 
  • At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation.
  • Survival data were updated with eight months of further follow-up since the first analysis presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting.
  • “We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data shown in this randomized clinical trial.
  • Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off (alive at 50.6 months).

Virios Therapeutics Announces Publication of International Patent for IMC-2 Covering Antiviral Treatment of Long-COVID

Retrieved on: 
Tuesday, March 26, 2024
Fibromyalgia, DSM-IV codes, Epstein–Barr virus, WIPO, COVID-19, Patient, Conditional sentence, Orthostatic intolerance, System, Celecoxib, Anxiety, Medical statistics, EBV, MD, Fatigue, Treatment, Therapy, Patent, Pain, Valaciclovir, FDA, Pharmaceutical industry

ATLANTA, March 26, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced that the World Intellectual Property Organization (WIPO) has published Virios’ global patent application titled “Valacyclovir and Celecoxib for the Treatment of Alzheimer’s and COVID-19”, which covers the use of IMC-2, a proprietary combination of valacyclovir and celecoxib. This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe.

Key Points: 
  • This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe.
  • An open-label, exploratory LC study sponsored by Virios demonstrated that treatment with the combination of valacyclovir and celecoxib resulted in clinical and statistically significant reductions in LC associated fatigue, orthostatic intolerance, pain and anxiety.
  • Previous estimates suggest that up to 10 million children in the US have also experienced LC.
  • There are no treatments approved by the FDA to treat the symptoms associated with LC, further highlighting the need for new treatments.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024
Radiation, Doctor of Philosophy, Immunotherapy, News, FOLFIRINOX, Growth, CADL, PR, CXCR4, Lead, PRS, Multiple myeloma, Poster, Pancreatic cancer, Gemcitabine, Fast Track, Liver, Incidence, Cancer, City, HSC, Chung, TME, Overalls, FACP, Therapy, Sickle cell disease, Columbia University, MAPK, Immune system, SNF, G-CSF, Woman, AIO, SCD, AACR, PD-1, Conference, TILS, Tumor microenvironment, BioLineRx, Clinical trial, Survival, Oncology, Filgrastim, Collection, American Cancer Society, Caregiver, USD, SWI, MD, Blood, FDA, TSX, Biotechnology, Pancreatic Cancer Action Network, Stem cell, RAS, Valaciclovir, PDAC, Patient, Natalizumab, ONC, PEI, Pharmaceutical industry

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

Virios Therapeutics Issues Shareholder Letter Highlighting Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Wednesday, February 28, 2024
Celecoxib, Fibromyalgia, Letter, Famciclovir, FDA, Management, Food, Conditional sentence, Valaciclovir, Therapy, Research, Pharmaceutical industry

ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.

Key Points: 
  • ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.
  • On behalf of the Virios directors and the executive team, we would like to provide a corporate progress report on several key topics as we proceed through the first quarter of 2024.
  • Approval of this proposal does not commit the Company to the execution of a reverse stock split.
  • The Virios team remains committed to delivering on the promise of combination antiviral therapy to address a multitude of serious health issues and illnesses.

Candel Therapeutics Sets Path to Success: Recent Achievements Pave the Way for a Promising 2024 Propelled by Key Value Drivers and Catalysts

Retrieved on: 
Monday, February 5, 2024
Injection, Serology, OS, Tumor microenvironment, Survival, Prostate cancer, Breast cancer, Immunotherapy, Pancreatic cancer, MD, PDAC, SITC, Enlightenment, Food and Drug Administration, Lung cancer, Society, Clinical trial, Therapy, Patient, Brain, Cancer, FDA, Biomarker, Trial of the century, Food, CADL, Fast track (FDA), CSO, Disease, Biology, Pancreatitis, Doctor of Philosophy, Valaciclovir, Conference, Pharmaceutical industry

“Candel is focused on delivering key value drivers to maximize the impact of its assets and to create substantial value to patients and other stakeholders.

Key Points: 
  • “Candel is focused on delivering key value drivers to maximize the impact of its assets and to create substantial value to patients and other stakeholders.
  • In 2023, we received Fast Track Designation from the FDA for CAN-2409, our most advanced product candidate, for both NSCLC and pancreatic cancer.
  • This platform is open for collaborations with external partners.”
    The Company's strategic prioritization of programs highlights Candel Therapeutics' commitment to operational excellence and efficiency.
  • This approach positions the Company for sustained success in the current dynamic market for new cancer therapeutics.

Virios Therapeutics Announces Plans to Advance Development of IMC-2 as Treatment for Symptoms Associated with Long-COVID

Retrieved on: 
Monday, January 22, 2024
Conditional sentence, Fibromyalgia, Patient, Therapy, Orthostatic intolerance, Partnership, Fatigue, Chronic fatigue syndrome, Celecoxib, Valaciclovir, FDA, Pharmaceutical industry

ATLANTA, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced plans for advancing IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC, also known as post-acute sequelae of SARS-CoV-2 infection (“PASC”). The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.

Key Points: 
  • The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.
  • “We believe the profound unmet medical need associated with LC symptoms provides a unique and timely opportunity for Virios to advance our combination therapy, IMC-2,” said Greg Duncan, Chairman and CEO of Virios Therapeutics.
  • “There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms.
  • In addition, we have received input from the FDA on development requirements and key endpoints associated with advancing IMC-2 into Phase 2 development as a treatment for LC symptoms.

Candel Therapeutics Receives FDA Fast Track Designation for CAN-2409 in Pancreatic Cancer

Retrieved on: 
Tuesday, December 12, 2023
Food, Survival, Immunotherapy, Caregiver, Radiation, FDA, Chemoradiotherapy, Injection, MD, Doctor of Philosophy, CADL, Therapy, Cancer, Clinical trial, Standard of care, Society, Annual general meeting, Pancreatic cancer, PDAC, SOC, Overalls, Patient, Valaciclovir, SITC, Pharmaceutical industry

NEEDHAM, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.

Key Points: 
  • NEEDHAM, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.
  • “We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel.
  • Candel remains on track to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024.
  • In parallel, the immunological changes observed in the resected pancreatic tissue after CAN-2409 administration suggested that this investigational treatment can activate an effective immunologic antitumoral response in this otherwise “cold” tumor.

Candel Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, November 9, 2023
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“We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG.

Key Points: 
  • “We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG.
  • Research and Development Expenses: Research and development expenses were $5.8 million for the third quarter of 2023 compared to $5.4 million for the third quarter of 2022.
  • Research and development expenses included non-cash stock compensation expense of $0.3 million for both the third quarter of 2023 and the third quarter of 2022.
  • General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the third quarter of 2023 and the third quarter of 2022.

Virios Therapeutics Announces Termination of At-The-Market Sales Agreement

Retrieved on: 
Monday, September 18, 2023
Drug discovery, Celecoxib, Polaris Sales Agreement, Disorder, Long COVID, Patent, Capital, Fibromyalgia, Conditional sentence, Therapy, Valaciclovir, Food, Fatigue, Pharmaceutical industry

ATLANTA, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia and Long-COVID, today announced that it provided notice of termination of the Capital on Demand™ Sales Agreement entered into between the Company and JonesTrading Institutional Services LLC on July 14, 2023 (the “Sales Agreement”).

Key Points: 
  • ATLANTA, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia and Long-COVID, today announced that it provided notice of termination of the Capital on Demand™ Sales Agreement entered into between the Company and JonesTrading Institutional Services LLC on July 14, 2023 (the “Sales Agreement”).
  • The Company has initiated the 10-day termination process under the Sales Agreement, with the official termination taking effect on September 28, 2023.
  • The Company will make no sales under the Sales Agreement during this period.
  • Prosecuting a patent application covering the treatment of Long-COVID and Alzheimer’s disease with combination antiviral formulations.

Virios Therapeutics Announces Halt to At-The-Market Offering Sales

Retrieved on: 
Monday, August 14, 2023
FM, Drug discovery, Food, Celecoxib, Capital, Fibromyalgia, Conditional sentence, Therapy, Valaciclovir, Pharmaceutical industry

ATLANTA, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia (“FM”) and Long-COVID, today announced that it has advised its sales agent, JonesTrading Institutional Services LLC (“JonesTrading”), to cease sales under the Capital on Demandtm Sales Agreement entered into between the Company and JonesTrading on July 14, 2023.

Key Points: 
  • ATLANTA, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia (“FM”) and Long-COVID, today announced that it has advised its sales agent, JonesTrading Institutional Services LLC (“JonesTrading”), to cease sales under the Capital on Demandtm Sales Agreement entered into between the Company and JonesTrading on July 14, 2023.
  • “Based on current market conditions and investor sentiment, we believe it is in the best interest of the Company and its stockholders to halt such sales,” noted Greg Duncan, Chairman and Chief Executive Officer of the Company.
  • Preparing for a Pre-Investigational New Drug meeting with the Food & Drug Administration.
  • Exploration of Potential Partnerships for both the FM and LC Programs.