• Connect with us
    • Information
      • About Us
      • Contact Us
      • Careers
      • Partnerships
      • Advertise With Us
      • Authors
      • Browse Topics
      • Events
      • Disclaimer
      • Privacy Policy
    • Australia
      North America
      World
    Login
    Investing News NetworkYour trusted source for investing success
    • North America
      Australia
      World
    • My INN
    Videos
    Companies
    Press Releases
    Private Placements
    SUBSCRIBE
    • Reports & Guides
      • Market Outlook Reports
      • Investing Guides
    • Button
    Resource
    • Precious Metals
    • Battery Metals
    • Base Metals
    • Energy
    • Critical Metals
    Tech
    Life Science
    Life Science Market
    Life Science News
    Life Science Stocks
    • Life Science Market
    • Life Science News
    • Life Science Stocks

    Oragenics Receives Supportive FDA Feedback for Initiating a Phase 2 Study Protocol for Oral Mucositis Treatment

    Investing News Network
    Aug. 30, 2016 07:36AM PST
    Life Science Investing News

    TAMPA, Fla.–(BUSINESS WIRE)–Oragenics (NYSE MKT: OGEN.BC), a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis (OM) today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study …

    TAMPA, Fla.–(BUSINESS WIRE)–Oragenics
    (NYSE MKT: OGEN.BC), a leader in the development of novel antibiotics
    against infectious disease and developing effective treatments for oral
    mucositis (OM) today announced that it has received feedback from the
    U.S. Food and Drug Administration (FDA) in response to the Company’s
    request for a Type C meeting, concerning Phase 2 study protocols for the
    Company’s OM therapeutic candidate, AG013. As part of the clinical
    protocol for the study, Oragenics expects to file the Investigational
    New Drug (IND) update in late 2016 and initiate the study with AG013 in
    the United States and Europe during early 2017.
    “We are pleased to have the FDA’s thorough feedback on protocol design
    for our Phase 2 trial and drug product manufacturing requirements for
    evaluating AG013 for the treatment of oral mucositis,” said Alan Joslyn,
    Oragenics’ Chief Executive Officer and President. “This is an important
    milestone in our effort to potentially provide cancer patients with a
    new therapy for treatment of oral mucositis.”
    OM results in a painful inflammation and mucosal ulceration in the
    lining of the oral cavity, throat and esophagus and is one of the most
    commonly reported adverse events associated with cancer chemotherapy
    affecting up to 500,000 patients annually. OM has a negative effect on
    patient well-being and if severe, negatively affects a patient’s cancer
    treatment regimen. At present, no drug is approved to prevent the
    condition broadly and current therapies are primarily palliative in
    nature, only addressing symptom relief but not treating the underlying
    causes of the condition.
    “Oral mucositis remains a major unmet need for cancer patients receiving
    cytotoxic radiation and chemotherapy,” said Stephen T. Sonis, DMD, DMSc,
    Senior Surgeon, Divisions of Oral Medicine, Brigham and Women’s Hospital
    and the Dana-Farber Cancer Institute. Dr. Sonis continued, “As suggested
    by the results of pre-clinical and clinical studies, AG013 may provide a
    unique delivery platform for an effective intervention. I’m excited that
    its development program has completed this important first step in
    moving forward.”
    Through the genetic engineering of a food grade microbe, Lactococcus
    lactis
    (L. lactis), by the Actobiotics Division of
    Intrexon Corporation (NYSE: XON), in situ production and
    secretion of peptide therapeutics has been developed, including AG013,
    an oral rinsing solution designed to deliver human Trefoil Factor 1
    (hTFF1) to protect and regenerate damaged mucosal lining of the oral
    cavity. Under an Exclusive Channel Collaboration Agreement with
    Intrexon, Oragenics has an exclusive worldwide license to develop and
    commercialize AG013 to treat oral mucositis in cancer patients.
    A Phase 1B clinical trial with AG013 in 25 head and neck cancer patients
    at high risk for OM demonstrated that AG013 was safe and well tolerated.
    Data published in the journal Cancer showed a 35% reduction in
    the duration of ulcerative OM in AG013-treated patients vs placebo
    treated patients. Additionally over 30% of patients treated with AG013
    were complete responders, defined as patients who did not develop OM,
    while all patients receiving placebo developed OM. A Phase 1
    pharmacokinetic study in 10 healthy volunteers showed that live AG013 L.
    lactis
    adhered to the entire oral mucosal surface up to 24 hours
    after administration of the rinse.
    AG013 has already been granted Orphan Drug status in the European Union
    and applications for Biologic License Application exclusivity and Fast
    Track designation with the FDA will be filed in the coming months.
    About the Study Design
    The Phase 2 double blind placebo controlled trial has been designed to
    evaluate the efficacy, safety, and tolerability of AG013 in patients
    being treated with standard regimens of concomitant chemoradiation
    therapy for common cancers of the head and neck. Not only is severe
    mucositis among the most common complications of treatment in this
    population, but its impact on patients’ ability to tolerate cancer
    therapy and risk of adverse health and resource use outcomes are
    frequent and devastating. Oragenics expects to announce additional
    information about the study design and timelines for the study once they
    are finalized.
    About Oragenics, Inc.
    We are focused on becoming the world leader in novel antibiotics against
    infectious disease and on developing effective treatments for oral
    mucositis. Oragenics, Inc. has established two exclusive worldwide
    channel collaborations with Intrexon Corporation, a synthetic biology
    company. The collaborations allow Oragenics access to Intrexon’s
    proprietary technologies toward the goal of accelerating the development
    of much needed new antibiotics that can work against resistant strains
    of bacteria and the development of biotherapeutics for oral mucositis
    and other diseases and conditions of the oral cavity, throat, and
    esophagus. For more information about Oragenics, www.oragenics.com.
    Safe Harbor Statement: Under the Private Securities Litigation
    Reform Act of 1995: This release includes forward-looking statements
    that reflect management’s current views with respect to future events
    and performance. These forward-looking statements are based on
    management’s beliefs and assumptions and information currently
    available. The words “believe,” “expect,” “anticipate,” “intend,”
    “estimate,” “project” and similar expressions that do not relate solely
    to historical matters identify forward-looking statements. Investors
    should be cautious in relying on forward-looking statements because they
    are subject to a variety of risks, uncertainties, and other factors that
    could cause actual results to differ materially from those expressed in
    any such forward-looking statements. These factors include, but are not
    limited to: our current need for financing to meet our operational needs
    and to be able to move our product candidates forward through
    pre-clinical and clinical development; our inability to obtain
    sufficient financing to conduct our business; any inability to obtain or
    delays in the FDA’s approval of clinical studies and testing; the future
    success of our studies and testing and any inability to also achieve
    favorable results in human studies; our ability to successfully develop
    and commercialize products; the financial resources available to us to
    continue research and development and the allocation of such resources
    among our product candidates: any inability to regain compliance with
    the NYSE MKT continued listing requirements and those other factors
    described in our filings with the U.S. Securities and Exchange
    Commission. Any responsibility to update forward-looking statements is
    expressly disclaimed.

    cancer treatmentclinical studieseuropean unioneuropefood and drug administrationgenetic engineering
    The Conversation (0)

    Go Deeper

    AI Powered
    Senior woman doing exercises alongside closeup of DNA.

    5 US Longevity and Anti-aging Stocks to Watch in 2025

    AMGEN TO PRESENT DATA AT ACR 2023 ACROSS EXPANDED RHEUMATOLOGY PIPELINE AND PORTFOLIO

    Latest News

    Outlook Reports

    Resource
    • Precious Metals
      • Gold
      • Silver
    • Battery Metals
      • Lithium
      • Cobalt
      • Graphite
    • Energy
      • Uranium
      • Oil and Gas
    • Base Metals
      • Copper
      • Nickel
      • Zinc
    • Critical Metals
      • Rare Earths
    • Industrial Metals
    • Agriculture
    Tech
      • Artificial Intelligence
      • Cybersecurity
      • Gaming
      • Cleantech
      • Emerging Tech
    Life Science
      • Biotech
      • Cannabis
      • Psychedelics
      • Pharmaceuticals

    Featured Stocks

    More featured stocks

    Browse Companies

    Resource
    • Precious Metals
    • Battery Metals
    • Energy
    • Base Metals
    • Critical Metals
    Tech
    Life Science
    MARKETS
    COMMODITIES
    CURRENCIES
    ×