Nasal administration

AdCOVID™, Altimmune’s Single Dose, Intranasal COVID-19 Vaccine Candidate, Prevents SARS-CoV-2-induced Disease and Blocks Viral Replication in Preclinical Studies of SARS-CoV-2 Infection

Retrieved on: 
Monday, March 15, 2021
Health sciences, Medicine, Clinical medicine, Medical research, Virology, COVID-19 vaccine, Vaccine, Nasal administration

GAITHERSBURG, Md., March 15, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced additional preclinical data for its single dose intranasal COVID-19 vaccine candidate, AdCOVID.

Key Points: 
  • GAITHERSBURG, Md., March 15, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced additional preclinical data for its single dose intranasal COVID-19 vaccine candidate, AdCOVID.
  • The preclinical studies were conducted at Altimmunes collaborating institutions, the University of Alabama at Birmingham (UAB) and Saint Louis University (SLU).
  • The data, which were obtained in the K18-hACE2 transgenic mouse model, showed that a single intranasal dose of AdCOVID provided 100% protection against a lethal challenge from the SARS-CoV-2 virus.
  • Based on data from Altimmunes other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine.

Oragenics Enters into Material Transfer Agreement with Biodextris for Mucosal Adjuvant for Intranasal COVID-19 Vaccine

Retrieved on: 
Tuesday, March 9, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Medicine, Health sciences, Clinical medicine, Clinical trials, COVID-19 vaccines, Vaccination, Vaccine, Virology, Nasal administration, Terra CoV-2, Biodextris Inc., Oragenics, Inc.

Oragenics, Inc. (NYSE American: OGEN) (Oragenics or the Company) announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Companys Terra CoV-2 vaccine against COVID-19.

Key Points: 
  • Oragenics, Inc. (NYSE American: OGEN) (Oragenics or the Company) announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Companys Terra CoV-2 vaccine against COVID-19.
  • The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.
  • This material transfer agreement both expands and advances the development of our Terra CoV-2 vaccine with a novel delivery option, said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics.
  • Joseph Zimmerman, President of Biodextris, added, We are delighted to partner with Oragenics on exploring the potential of their Terra CoV-2 vaccine.

Journal of Allergy and Infectious Disease Review Confirms Nasal Hygiene Options Are Effective Tools as Part of Multilayered Defense Against COVID-19

Retrieved on: 
Thursday, February 25, 2021
Research, Infectious diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Health sciences, Medicine, Health, Dosage forms, Occupational safety and health, Nose, Nasal spray, Nasal administration, Nasopharyngeal swab, Coronavirus disease, COVID-19 pandemic

A new review published in the highly regarded Journal of Allergy and Infectious Disease finds that nasal hygiene options (such as nasal sprays) are effective tools in combating COVID-19 pandemicas part of a multilayered defense against the virus.

Key Points: 
  • A new review published in the highly regarded Journal of Allergy and Infectious Disease finds that nasal hygiene options (such as nasal sprays) are effective tools in combating COVID-19 pandemicas part of a multilayered defense against the virus.
  • We propose that intranasal administration of virucidal and antiviral therapies may be a novel strategy to provide an added clinical benefit by decreasing the viral activity in the nasal pathway, thus preventing disease transmission, managing the disease severity and limiting complications.
  • Furthermore, on day 7, patients tested negative on repeat RT-PCR nasopharyngeal swab instead of the average 14-day period of negativization of COVID-19.
  • The nasal spray administered in that study was Xlearwhich is available at almost all pharmacies, grocery stores, and natural retailers in the USA and is also available worldwide.

DGAP-News: Virpax(R) Pharmaceuticals Inc.: Virpax Begins IND Enabling Studies of Envelta(TM)

Retrieved on: 
Tuesday, February 23, 2021
Health sciences, Health, Euphoriants, Morphinans, Dosage forms, Drug discovery, Drug delivery, Medical equipment, Nasal administration, Enkephalin, Clinical trial, Heroin

Anthony P. Mack, Chairman and CEO of Virpax stated, "The commencement of these critical pre-clinical studies takes us one step closer to the clinic.

Key Points: 
  • Anthony P. Mack, Chairman and CEO of Virpax stated, "The commencement of these critical pre-clinical studies takes us one step closer to the clinic.
  • Dr. Jeffrey Gudin, principal investigator and co-founder of Virpax, has been working in partnership with the NCATS since we announced the CRADA in August 2020.
  • Envelta(TM) is an intranasal enkephalin drug product candidate formulation based on nanotechnology which enables the delivery of the drug product to the brain.
  • Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery.

Altimmune To Announce Year End 2020 Financial Results on February 25, 2021

Retrieved on: 
Monday, February 22, 2021
Health sciences, Life sciences, Health, Vaccines, Medical research, Pharmaceutical industry, Vaccination, Vaccine, Virology, Live attenuated influenza vaccine, Nasal administration, Biopharmaceutical

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.

Key Points: 
  • Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.
  • Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID), anthrax (NasoShield) and influenza (NasoVAX); an intranasal immune modulating therapeutic for COVID-19 (T-COVID); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell).
  • For more information on Altimmune, please visit www.altimmune.com .

Altimmune Announces FDA Clearance of AdCOVID™ IND Application

Retrieved on: 
Wednesday, February 17, 2021
Health sciences, Life sciences, Health, Pharmaceutical industry, Vaccines, Biotechnology, Immunology, Nasal administration, Immunity, Clinical trial, Biopharmaceutical

Altimmune expects to commence patient enrollment in the Phase 1 clinical trial in the coming week.

Key Points: 
  • Altimmune expects to commence patient enrollment in the Phase 1 clinical trial in the coming week.
  • We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic, said Vipin K. Garg, President and Chief Executive Officer of Altimmune.
  • FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration.
  • Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.

AIM ImmunoTech Announces Ethics Committee Approval to Commence Phase 1 Clinical Study of Ampligen as an Intranasal Therapy

Retrieved on: 
Tuesday, February 16, 2021
Clinical medicine, Medicine, Health sciences, Rintatolimod, Ethics committee, Nasal administration

Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

Key Points: 
  • Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.
  • This will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally.
  • The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each.
  • We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial, said AIM CEO Thomas K. Equels.

Tonix Pharmaceuticals Licenses Technology for Treating Prader-Willi Syndrome, a Rare Genetic Eating Disorder, from the French National Institute of Health and Medical Research (Inserm)

Retrieved on: 
Thursday, February 11, 2021
Branches of biology, Drugs, Clinical medicine, Antidiuretics, Neuropeptides, Neurotransmitters, Orgasm, Oxytocin, Prader, Breastfeeding, Nasal administration

The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication.

Key Points: 
  • The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication.
  • The new program at Tonix has the designation TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome.
  • Intranasal oxytocin improves suckling in newborn animals but also suppresses feeding behaviors in adult animal models.
  • As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products.

AIM ImmunoTech Enters into Agreement for Proposed Intranasal Safety Study of Ampligen

Retrieved on: 
Friday, January 29, 2021
Clinical research, Health sciences, Health, Medicine, Design of experiments, Rintatolimod, AIM ImmunoTech, Placebo-controlled study, Clinical trial, Nasal administration, Placebo, Treatment and control groups

OCALA, Fla., Jan. 29, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIMs drug Ampligen as an intranasal therapy, a critical step in the companys ongoing efforts to develop Ampligen as a COVID-19 treatment.

Key Points: 
  • OCALA, Fla., Jan. 29, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIMs drug Ampligen as an intranasal therapy, a critical step in the companys ongoing efforts to develop Ampligen as a COVID-19 treatment.
  • CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.
  • Current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group, for a total of 40 healthy subjects.
  • They will receive intranasal dosing every other day for 13 days, for a total of seven doses each.

Vallon Pharmaceuticals Announces Presentation of ADAIR Pharmacokinetics and Pharmacodynamic Data at the Virtual 2021 APSARD Annual Meeting

Retrieved on: 
Tuesday, January 19, 2021
Drugs, Branches of biology, Clinical medicine, Amphetamine, Stimulants, Nootropics, Anorectics, Substituted amphetamines, Attention deficit hyperactivity disorder, Nasal administration, Medroxyprogesterone acetate, Magnesium in biology

There remains a clear unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse.

Key Points: 
  • There remains a clear unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse.
  • The first study enrolled 24 subjects and was designed to compare the PK of d-AMPH from ADAIR 10 mg to IR d-AMPH 10 mg administered orally.
  • The primary PD endpoint demonstrated manipulated intranasal ADAIR had significant reduction in drug liking (p
  • All other PD endpoints reflected abuse-deterrent properties for intranasal ADAIR relative to intranasal d-AMPH (e.g., Take Drug Again, High, Subjective Drug Value).