NEW SINUSITIS DRUG FAST-TRACKED ... a ray of HOPE maybe?

Discussion in 'Fibromyalgia Main Forum' started by victoria, Jun 8, 2006.

  1. victoria

    victoria New Member

    Well I was wondering if it was the world's best kept secret that something had EVER come out of that Landmark study that the Mayo Clinic did - so I got busy and did some researching!

    I found that YES! ! ! there is a new drug that has been undergoing trials already and is being fast-tracked by the FDA--

    -- and there is already a diagnostic test available by this company... I am enthused as it has been a long time that I've had any hope!

    For details and ph # on where your doctor can order the test, read the following article:

    FDA Grants Accentia Biopharmaceuticals
    Fast Track Status for SinuNaseTM
    A Drug To Help Chronic Sinusitis

    Article Date: 15 Apr 2006
    (excerpted etc to make it more readable (I hope))

    Accentia Biopharmaceuticals, Inc. (Nasdaq:ABPI) has been notified that the U.S. Food and Drug Administration (FDA) granted Fast Track status to SinuNaseTM, the Company's intranasal Amphotericin B formulation.

    To the best of the Company's knowledge, SinuNase is the first and only drug candidate for chronic sinusitis (CS) to receive Fast Track status from the FDA.

    Chronic sinusitis (CS), also known as chronic rhinosinusitis (CRS), is one of the most common diseases suffered by Americans today, affecting an estimated 31 million patients in the U.S. CS is a chronic inflammatory disease of the nasal and sinus mucosa that persists for greater than three months.

    Accentia is commercializing a diagnostic as well as developing a treatment for CS, based on published technology developed at the Mayo Clinic.

    Investigators there reported that a ubiquitous, normally innocuous mold, Alternaria, colonizes the mucus of the nose and sinus of virtually everybody, but in patients with CS this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eosinophilic major basic protein (MBP) in the mucus.

    The release of protein then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS.

    Based on these insights, investigators at Mayo developed a unique diagnostic for CS -- one that tests mucus from the nose for MBP (eosinophilic major basic protein ).

    In patients with CS, investigators at Mayo reported that the MBP of mucus from the nose is elevated. In patients who have only seasonal or perennial allergic rhinitis, it is routinely undetectable.

    This diagnostic is available commercially as CRSFungal Profile from Accentia, intended as an adjunct to the clinical and radiological diagnosis of CS. (More information on the diagnostic is available by calling the Company's laboratory partner, IMMCO, at 800-537-8378. )

    Also based on these insights, investigators at Mayo and elsewhere have published small clinical studies on the efficacy and safety of a low-dose antifungal, applied intranasally.

    In particular, they have reported on the use of a lavage of 0.01% Amphotericin B for the treatment of the symptoms and signs of CS. Because of the inciting role that the fungal antigen plays in the chronic inflammatory response of the mucosa, it appears that a muco-administered antifungal takes a few weeks to maximize response.

    In one published study from Geneva University, for example, intranasal amphotericin B 0.01% was applied for four weeks and, among patients with partial nasal obstruction from polyposis, about 50% had complete resolution of their polyps.

    The diagnosis and treatment of CS, based on the history, nasal endoscopy and CT scan of the sinuses, remains challenging. There are, for example, no prescription pharmaceuticals, including any antibiotics, approved for this condition.

    In addition, the FDA has instructed manufacturers of over-the-counter (OTC) decongestant products claiming to treat sinus disease to remove the claims by April 2007. A major obstacle to the rational design of a laboratory diagnostic or prescription pharmaceutical has been the lack of a plausible theory of causation.

    Under the FDA Modernization Act of 1997, a new drug may be designated "Fast Track" provided the agency feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions.

    With Fast Track status for SinuNase, Accentia is now eligible to submit a new drug license application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its NDA.

    Accentia is preparing to commence its Phase 3 placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month double-blinded comparison of symptomatic relief in patients randomized for treatment with either SinuNase or a placebo control.

    Background on Chronic Sinusitis and SinuNase

    Accentia is now developing, under an IND (Investigational New Drug), a very-low-dose intranasal lavage formulation of Amphotericin B (SinuNase) for the treatment of the signs and symptoms of CS. The initial study population is comprised of refractory patients who have undergone sinus surgery for CS but are now struggling with recurrent CS.

    These four-month randomized, double-blind, placebo-controlled clinical trials are designed to test the efficacy and safety of this particular intranasal antifungal for this indication.

    One of the many reasons Accentia chose Amphotericin B is that it has very low absorption across mucus membranes, and in this rather unique situation the Company does not need absorption of the drug into the sinus mucosa or the rest of the body. According to this disease model, the drug's desired site of action is confined to the mucus layer.

    About Accentia Biopharmaceuticals, Inc.

    Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

    Two of these products are SinuNase(TM) and BiovaxID. The Company's SinuNase(TM) product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research.

    --------------

    Glad I did some researching - I am going to see if i can get their test done at least for now...

    I truly hope this helps us all. Altho so far I've not had polyps myself, the fact that this new RX has been shown to get rid of them is pretty amazing.

    all the best,
    Victoria



    [This Message was Edited on 06/08/2006]
  2. victoria

    victoria New Member



    with all the chronic sinusitis here... anybody participating in trials?

  3. victoria

    victoria New Member