Nasal administration

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

Tuesday, February 23, 2021 - 1:11pm

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

Monday, February 22, 2021 - 9:30pm

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

Wednesday, February 17, 2021 - 12:02pm

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

Tuesday, February 16, 2021 - 2:15pm

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)

Thursday, February 11, 2021 - 12:00pm

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

Friday, January 29, 2021 - 11:55am

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

Tuesday, January 19, 2021 - 1:30pm

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).

Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial

Wednesday, December 23, 2020 - 9:01pm

The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data.

Key Points: 
  • The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data.
  • We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID.
  • AdCOVID is a single-dose intranasal COVID-19 vaccine candidate developed by Altimmune based on the Companys significant experience in the development of intranasal vaccines for respiratory pathogens.
  • Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.

Tonix Pharmaceuticals Acquires Exclusive License to University of Geneva Technology for Oxytocin-Based Treatments for Treating Insulin Resistance, Diabetes and Obesity, Expanding Proprietary Uses for TNX-1900 (Intranasal Potentiated Oxytocin)

Tuesday, December 22, 2020 - 12:00pm

This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity.

Key Points: 
  • This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity.
  • Our lead indication for TNX-1900 is for the treatment of migraine, said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.
  • Subsequent to the University of Geneva inventions, a number of studies have shown that intranasal oxytocin has effects on insulin resistance and weight2-4, continued Dr. Lederman.
  • In June 2020, Tonix acquired its potentiated oxytocin technology and development program from Trigemina, Inc., and assumed licenses for certain related technologies from Stanford University.

Inhaled and Intranasal Products Contract Service Providers Market, 2030

Monday, December 7, 2020 - 1:45pm

DUBLIN, Dec. 7, 2020 /PRNewswire/ -- The "Inhaled and Intranasal Products Contract Service Providers Market, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 7, 2020 /PRNewswire/ -- The "Inhaled and Intranasal Products Contract Service Providers Market, 2020-2030" report has been added to ResearchAndMarkets.com's offering.
  • The 'Inhaled and Intranasal Products: Contract Service Providers Market (Focus on Drugs and Drug Delivery Systems), 2020 - 2030' report features an extensive study of the current market landscape and future opportunities for the contract service providers focused on drugs and drug delivery systems.
  • An insightful discussion on the impact of COVID-19 outbreak on the inhaled and intranasal service providers.
  • Who are the leading contract service providers offering inhalable and intranasal products related services, across the world?