Navigation Links
Accentia Biopharmaceuticals Announces Favorable Interim Blinded,Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial,for Chronic Sinusitis

TAMPA, Fla.--(BUSINESS WIRE)--Jun 28, 2007 - Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) announced on Wednesday, June 27 at the Jefferies Healthcare Conference that its interim analysis of the blinded data on the first fifty patients in the Fast-Tracked Phase 3 clinical study of SinuNase(TM), at 8 weeks post-randomization, has demonstrated substantial improvement in resolution of one or both of the cardinal symptoms of chronic sinusitis, and substantial improvement in intranasal polyposis. Resolution of both cardinal symptoms at the end of 16 weeks is the primary endpoint of the ongoing Phase 3 study. Based on this interim blinded data, approximately 42% of patients randomized reported resolution of one or both cardinal symptoms. In addition, approximately 47% of patients were evaluated as having improved endoscopy scores. It should be noted, prior to randomization, potential trial participants were required to irrigate with saline twice daily for two weeks and only those who showed no placebo effect were randomized. The randomization between SinuNase and placebo control is 1:1, meaning that 50% of the patients in the blinded interim analysis should be on SinuNase, and 50% on placebo control.

"The data reported is very encouraging," said Dr. Frank E. O'Donnell Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "While we cannot determine which patients are receiving SinuNase and which are receiving placebo control until the study is completed and unblinded, the fact that there are resolution of symptoms and improvement in endoscopy in a substantial percentage of patients suggests to me that we are on track to reach our anticipated outcome for SinuNase in the Phase 3 study. It seems unlikely to me that patients receiving placebo would have a substantial improvement in polyps. In fact, in patients who experienced no resolution of symptoms, the endoscopy scores improved by just 2%. In pa
'"/>




Page: 1 2 3 4

Related medicine technology :

1. Accentia Biopharmaceuticals Scientific Presentations Demonstrate Increasing Acceptance of Fungal Etiology of Chronic Sinusitis at the Annual Meeting of the American Academy of Allergy, Asthma, and Immunology
2. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
3. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
4. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Mechanism of Action and Clinical Activity of Sulonex(TM) (sulodexide oral gelcap) at the Upcoming American Diabetes Association 67th Scientific Sessions in Chicago, Illinois
5. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
6. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
10. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
11. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
Post Your Comments:
(Date:2/27/2015)... , Feb. 27, 2015  Two mass ... in applications as their effectiveness is established, ... Information.  Kalorama Information says that while mass ... most powerful tool in proteomic biomarker discovery ... through its traditional techniques has struggled to ...
(Date:2/26/2015)... 26, 2015  Today the National Safety Council ... and physical side effects of pain medications ... as Vicodin and Oxycontin, are safer options than over-the-counter ... prescription painkillers than on heroin and cocaine combined," said ... NSC. "Yet, these medications are marketed as the Cadillac ...
(Date:2/26/2015)... 2015 Every year many millions of donations ... disease.  Nevertheless, year after year doctors and the medical ... first test to determine the status of heart health ... not, even though that technology is over 100 years ... doctors know, (while most patients do not know) that ...
Breaking Medicine Technology:Report: "Softer" Mass Spec Techniques Gaining Popularity in Biomarker Discovery 2Report: "Softer" Mass Spec Techniques Gaining Popularity in Biomarker Discovery 3National Safety Council: Opioid prescription painkillers have hidden, deadly side effects 2National Heart Health Month In February 2
... Oct. 26, 2011 nContact, Inc., the leading innovator ... its new corporate websites, www.ncontactinc.eu and ... reflects the evolution of nContact,s technology and the market ... worldwide. "The new websites are excellent educational ...
... DIEGO, Oct. 26, 2011 ADVENTRX Pharmaceuticals, Inc. (NYSE ... met with the U.S. Food and Drug Administration (FDA) ... of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation ... non-inferiority study (Study 514-02) with a primary objective of ...
Cached Medicine Technology:nContact, Inc. Launches New Corporate Websites 2ADVENTRX and FDA Reach Agreement on Pivotal Study for ANX-514 2ADVENTRX and FDA Reach Agreement on Pivotal Study for ANX-514 3ADVENTRX and FDA Reach Agreement on Pivotal Study for ANX-514 4
(Date:3/1/2015)... Atlanta, GA (PRWEB) March 01, 2015 ... of Evelyn King and Carolyn Roddy to the professional ... Director of Compliance, graduated from The Ohio State University-Mortiz ... over 15 years of experience working with several Fortune ... specifically in the area of corporate benefits. Her experiences ...
(Date:2/28/2015)... February 28, 2015 In recent years Medical ... of practicing physicians as a way for them to expand ... regarding Cannabis as medicine. Since the FDA still lists Cannabis ... resources available to licensed physicians that can help guide ... Dr. Deborah Malka in Santa Cruz, CA is a ...
(Date:2/28/2015)... The Heart Fit Clinic started doing ... the machine. The Heart Fit Clinic is also selling ... franchise model. The goal is to scale the business ... To buy External Counterpulsation machines can be ... through this process and achieve the desired results. ...
(Date:2/28/2015)... 2015 Indosoft Inc , developers ... Asterisk, are pleased to announce the development of Q-Suite ... 5.8 versions of Q-Suite, this new version will include ... of new features to the leading edge call center ... 5.9 will add features to enhance security and protection. ...
(Date:2/28/2015)... February 28, 2015 National ... outsourced sales, marketing and supply chain management for ... Botanicals, is bringing its award winning solutions for ... Botanicals’ products are specifically created to combat thinning-damaged ... BIOTA is committed to marrying science with nature ...
Breaking Medicine News(10 mins):Health News:ERISAPros Recruits Evelyn King, J.D. and Carolyn Roddy, J.D. to its Professional Staff 2Health News:Reputable Cannabis Doctor In Santa Cruz and Monterey Joins the Medical Cannabis Network 2Health News:Clinicians Can Now Purchase External Counterpulsation with Heart Fit Clinic 2Health News:Indosoft Proudly Announces Q-Suite 5.9 Call Center Software for Asterisk 2Health News:BIOTA Botanicals Brings Thinning-Damaged Hair Solutions to the Hair Care Aisle at Walgreens 2Health News:BIOTA Botanicals Brings Thinning-Damaged Hair Solutions to the Hair Care Aisle at Walgreens 3
... said that suicide rates in Sri Lanka has increased in multifold ... oleander plants even for the most trivial reasons. ,This ... over the island. It has yellow trumpet-like flowers and a fruit ... and one of these seeds is enough to kill you, the ...
... Ashok Bhatt has confirmed the absence of bird-flu cases in ... yielded negative results. ,Kadar Murghiwala, a poultry dealer ... died. Suspecting a possible bird-flu infection following complaints of fever, ... an isolation ward. The symptoms of bird-flu as listed by ...
... diabetes. New South Wales (NSW) has recorded a 300% increase ... 10 years. Experts have asked the health system and the ... it continues it is expected that about 2 million will ... increase is that of the diet and lifestyle factors. About ...
... revamp the drug system. Health Minister George Smitherman said ... drug program//. He also said that he would introduce ... and sustainable. They will also speed up the slow ... The taxpayers have not received fair value for their ...
... infant and maternal mortality rates in the state, Madhya Pradesh ... a study conducted by a voluntary group//. ,The state, ... mortality rate of 83 per 1,000 childbirths while the maternal ... ,"Despite Madhya Pradesh having the second highest rate of ...
... chemical in the United States. It is obtained primarily ... yellow liquid at room temperature//. It has a sweet ... both natural processes and human activities. Benzene is also ... It is of exceptional importance commercially on account of ...
Cached Medicine News:Health News:Its High Time the Australian Government Takes Steps against Diabetes 2Health News:The Multi-Faceted Chemical Benzene 2Health News:The Multi-Faceted Chemical Benzene 3Health News:The Multi-Faceted Chemical Benzene 4Health News:The Multi-Faceted Chemical Benzene 5Health News:The Multi-Faceted Chemical Benzene 6
... Used for stone manipulation and removal in the ... basket to retain its shape following extreme torsion. ... capture by allowing the basket to open at ... stone. The tipless design reduces the likelihood of ...
... Used to establish and maintain nephrostomy ... segment promotes patency and allows the ... Supplied sterile in peel-open packages. Intended ... is advised; stent must not remain ...
... Used to provide drainage following open ... are employed to provide enhanced drainage ... provides maximum softness for enhanced patient ... to latex catheters. Supplied sterile in ...
... Used for percutaneous placement ... in the renal pelvis ... sterile in peel-open packages. ... CAUTION: Periodic evaluation is ...
Medicine Products: