GREENWOOD VILLAGE, Colo., June 11, 2012 /PRNewswire/ --Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.
(Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)
Dr. David Bar-Or, Ampio's Chief Science Officer (CSO), explained "The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT) and reported in microns. The study was double masked and included 32 patients with moderate to severe diabetic macular edema (range 316-707microns) that were treated orally with either placebo or one of three doses of Optina. Central retinal thickness and retinal volumes were measured at baseline and at 4 and 12 weeks of treatment. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina. For higher BMI (BMI=35) patients, higher doses of Optina were more effective and for lower BMI (BMI=26) patients, lower doses were more effective. The improvement of efficacy by adjusting the dose to the BMI is in agreement with both in vitro data as well as with the known strongly lipophilic nature of Optina. At one of the low doses, regardless of BMI, there was a reduction of the subfield central retinal thickness of approximately 20% at 4 and at 12 weeks, which was statistically significant from placebo for the higher BMI group (p = 0.01). The lowest dose of Optina showed a trend towards statistically significant reductions in central retinal thickness in the lowest BMI groups (p = 0.11 and p = 0.13) at 4 and 12 weeks, despite the small number of patients randomized to this dose.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer (CRO) further explained "These results are very important in the planning of our US trial as dose adjustments by body weight/BMI of Optina will be part of the trial design. Ampio has requested and received confirmation of a pre-IND meeting with the FDA on Optina for DME, which will take place in July 2012. That discussion will include complete analysis of the data including secondary end points."
Ampio's CEO, Michael Macaluso, noted "The company is meeting all of its clinical goals, right on schedule. In addition to this confirmed July pre-IND meeting with the FDA for Optina,
Reaching these critical milestones to commercialization for our two most important anti-inflammatory drugs (OptinaTM and AmpionTM) and our lead sexual dysfunction drug (ZertaneTM) in a three month time frame is a tribute not only to the quality of the drugs but to the hard work and competence of our clinical team"
About Diabetic Retinopathy, Diabetic Macular Edema and current treatmentsDiabetic retinopathy is damage to the retina of the eyes caused by complications of diabetes mellitus and often resulting in loss of visual acuity and blindness. Macular edema of the eyes is often an early form of diabetic retinopathy that causes significant vision loss. Almost all Type 1 diabetics and more than 60% of Type 2 diabetics will develop retinopathy. There is no effective daily drug treatment for diabetic retinopathy other than general measures, such as controlling blood sugar, hypertension, blood lipids, etc. Due to the global diabetes epidemic, diabetic retinopathy is recognized as a high, unmet medical need that would benefit from having oral therapeutic options available. The only treatments available for macular edema now are laser therapy, injection or implantation of drugs into or around the eyeball (not approved in the US or Canada). To our knowledge, Optina is the only proposed oral treatment for this condition.
About OptinaOptina is an orally administered ultra low dose of danazol, for the treatment of diabetic macular edema (DME). Ampio's Chief Scientific Officer discovered an unexpected activity in his investigation of the mechanism of action of danazol: very low doses reversed inflammation induced increases in the permeability of blood vessels, thus reducing vascular leakage. Dr. Bar-Or subsequently managed in-vitro studies that suggested this effect may reduce the vasogenic edema produced by various vascular leak syndromes, including diabetic macular edema (DME) which can impair vision and cause blindness The specific Optina dosagesused in the trial are proprietary and Ampio was recently awarded patents for methods of use, formulation and dosages of Optina in the US, Canada and Europe. Additional patents are pending worldwide. Because of the newly allowance of these patents, Optina benefits from a full patent life.
Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema, ITP and fibrocystic disease of the breast.
About AmpioAmpio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, http://www.ampiopharma.com.
See original here:
Ampio Announces Positive Clinical Trial Results for the Treatment of Diabetic Macular Edema with Orally Administered ...
- Last Longer In Bed With Subliminal Hypnosis - Cure Premature Ejaculation - Video - April 8th, 2012 [April 8th, 2012]
- PREMATURE EJACULATION - Video - April 8th, 2012 [April 8th, 2012]
- Cure premature ejaculation -Learn how to control premature ejaculation - Video - April 8th, 2012 [April 8th, 2012]
- Premature ejaculation: an office problem - Video - April 8th, 2012 [April 8th, 2012]
- How to Control Your Premature Ejaculation - PROMESCENT speaks with Felice Dunas - Video - April 8th, 2012 [April 8th, 2012]
- How Do I Know If I Have Premature Ejaculation? - Video - April 8th, 2012 [April 8th, 2012]
- Zoloft For Premature Ejaculation - Does It Work? - Video - April 8th, 2012 [April 8th, 2012]
- Does Hypnosis For Premature Ejaculation Work? - Video - April 8th, 2012 [April 8th, 2012]
- Can Viagra Treat Premature Ejaculation? - Video - April 8th, 2012 [April 8th, 2012]
- Supplements For Premature Ejaculation - Do They Work? - Video - April 8th, 2012 [April 8th, 2012]
- Talk to DaveyJCole #11 : Older Girls, Premature Ejaculation, Weight Loss, Numbers - April 8th, 2012 [April 8th, 2012]
- In the Bedroom with Dr. Laura Berman - Premature Ejaculation - Oprah Winfrey Network - Video - April 8th, 2012 [April 8th, 2012]
- Pelvic Floor Exercise For Your Premature Ejaculation Problem - Video - April 8th, 2012 [April 8th, 2012]
- Classic Col Elliott On Premature Ejaculation - Video - April 8th, 2012 [April 8th, 2012]
- Premature Ejaculation Cure Using Pelvic Floor Exercises - Video - April 8th, 2012 [April 8th, 2012]
- Premature Ejaculation Cures + Jodie Foster + Late Show with David Letterman - Video - April 8th, 2012 [April 8th, 2012]
- How To Avoid Premature Ejaculation - 4 Practical Delaying Tips - Video - April 8th, 2012 [April 8th, 2012]
- Premature Ejaculation Cures + Blake Lively + Late Show with David Letterman - Video - April 8th, 2012 [April 8th, 2012]
- Premature Ejaculation Cures + Lisa Kelly + Late Show with David Letterman - Video - April 8th, 2012 [April 8th, 2012]
- Premature Ejaculation Cures + Seth Meyers + SNL + Late Show with David Letterman - Video - April 8th, 2012 [April 8th, 2012]
- Stendra (Avanafil) For Erectile Dysfunction Approved By FDA - April 29th, 2012 [April 29th, 2012]
- Research and Markets: Case Studies in Abnormal Psychology, 9th Edition Includes a Number of Transcripts of Therapy ... - May 4th, 2012 [May 4th, 2012]
- Furiex Pharmaceuticals Announces Agreement to Transfer Priligy® Product Rights - May 15th, 2012 [May 15th, 2012]
- Furiex Pharmaceuticals and Menarini Announce License Agreement for Priligy® - May 15th, 2012 [May 15th, 2012]
- Furiex Enters Agreement For Priligy Product Rights - May 15th, 2012 [May 15th, 2012]
- Hideous suit, rictus grin, silver strands... has former French first lady Carla Bruni-Sarkozy come to this? - May 18th, 2012 [May 18th, 2012]
- Making a connection - May 27th, 2012 [May 27th, 2012]
- The 7 Greatest Viral Andy Samberg Videos - June 6th, 2012 [June 6th, 2012]
- Newton: 'Sliced Bread' getting a little stale? - June 8th, 2012 [June 8th, 2012]
- Plethora Solutions - PSD502 Regulatory Submission Update - June 11th, 2012 [June 11th, 2012]
- MARKET REPORT: Bears battered by euro rescue - June 12th, 2012 [June 12th, 2012]
- Plethora Solutions - Subscription of Shares - June 14th, 2012 [June 14th, 2012]
- Why is masturbation such a taboo topic? - June 15th, 2012 [June 15th, 2012]
- Plethora Solutions - Issue of Equity - Directors' Interest - June 15th, 2012 [June 15th, 2012]
- From an inventor of Viagra, a spray to help love last beyond a moment - June 16th, 2012 [June 16th, 2012]
- Ampio Reports Successful Type B Pre-IND Meeting with the FDA for its Drug Zertane™ to treat Premature Ejaculation (PE) - June 22nd, 2012 [June 22nd, 2012]
- Ampio Reports Successful Type B Pre-IND Meeting With FDA For Zertane To Treat PE - June 22nd, 2012 [June 22nd, 2012]
- Ampio signs deal with Biocon unit on sexual dysfunction drug - July 2nd, 2012 [July 2nd, 2012]
- Ampio Contracts with Syngene to Manufacture Zertane-ED™, its Recently Patented Combination Drug to Treat both ... - July 2nd, 2012 [July 2nd, 2012]
- Ampio Contracts with Syngene to Manufacture Zertane-ED(TM), its Recently Patented Combination Drug to Treat both ... - July 2nd, 2012 [July 2nd, 2012]
- Equity Briefing : Ampio Pharmaceuticals, Amylin Pharmaceuticals and Cytori Therapeutics moving higher - July 2nd, 2012 [July 2nd, 2012]
- Promescent® Featured in World Meeting on Sexual Medicine 2012 - August 3rd, 2012 [August 3rd, 2012]
- Revolutionary Device for Premature Ejaculation Treatment - September 6th, 2012 [September 6th, 2012]
- “No, honey, it really is OK” - September 19th, 2012 [September 19th, 2012]
- Research and Markets: Premature Ejaculation - Pipeline Review, H2 2012 - September 30th, 2012 [September 30th, 2012]
- Liu Xiang furious after being featured in premature ejaculation ad - September 30th, 2012 [September 30th, 2012]
- Chinese sports ads are the best sports ads - September 30th, 2012 [September 30th, 2012]
- Gross and Embarrassing - October 5th, 2012 [October 5th, 2012]
- Dan Savage: “It was going to be a joke” - October 7th, 2012 [October 7th, 2012]
- CAPScall of the Week: Ampio Pharmaceuticals - October 10th, 2012 [October 10th, 2012]
- Rizer XL Rated #1 Male Enhancement Pill by Total Penis Health - October 13th, 2012 [October 13th, 2012]
- Ejaculation Trainer | How To Prevent Premature Ejaculation Permanently – Health Review Center - October 16th, 2012 [October 16th, 2012]
- Tackling the Unspoken Taboo – Hypnotherapy Directory Reveals the Secret to Banishing Sexual Issues from the Bedroom - October 16th, 2012 [October 16th, 2012]
- Plethora's PSD502 drug has mass market potential - October 17th, 2012 [October 17th, 2012]
- Priligy premature ejaculation - November 1st, 2012 [November 1st, 2012]
- Last Longer In Bed - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 14 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 12 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 10 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 8 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 7 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 6 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 4 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 3 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 2 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 17 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 11 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 5 - Video - November 1st, 2012 [November 1st, 2012]
- Girls of Prague - clip 1 - Video - November 1st, 2012 [November 1st, 2012]
- Cure Hemorrhoids Fast - Video - November 1st, 2012 [November 1st, 2012]
- How To Get Premature Ejaculation Help - Video - November 1st, 2012 [November 1st, 2012]
- Advanced Male Medical Center Raises Awareness for Atherosclerosis - November 3rd, 2012 [November 3rd, 2012]
- Shilajit Capsule / premature ejaculation nocturnal Shilajit Capsule For Men Sexual Health Wellbegin - Video - November 3rd, 2012 [November 3rd, 2012]
- Trance for premature ejaculation - Video - November 3rd, 2012 [November 3rd, 2012]
- Killpocalypse! - Video - November 3rd, 2012 [November 3rd, 2012]
- Prevent Premature Ejaculation -Tips For Learning How to Prevent Premature Ejaculation - Video - November 3rd, 2012 [November 3rd, 2012]
- how to stop premature ejaculating - learn more here - Video - November 3rd, 2012 [November 3rd, 2012]
- premature ejaculation - learn more here - Video - November 3rd, 2012 [November 3rd, 2012]
- What exactly is premature ejaculation? Special Presentation Ejaculation By Command - Video - November 3rd, 2012 [November 3rd, 2012]
- How I Cured My Premature Ejaculation Using Ejaculation Ejaculation by Command - Video - November 3rd, 2012 [November 3rd, 2012]