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  • Ampio Pharmaceuticals, Inc. (AMPE) Secures Key US/Canadian Patents For Diabetes-Related Vision Loss Drug Optina™

    Today, Ampio Pharmaceuticals, the dynamic biopharma developer which has assembled an impressive portfolio of proprietary drugs for treating eye (diabetic macular edema - Optina™), kidney, and metabolic disease, as well as chronic inflammation (Ampion™), male sexual dysfunction (Zertane™), and central nervous system disease, reported reception of a notice of allowance for a patent from the United States Patent and Trademark Office covering Optina, also receiving a similar allowance from the Canadian Intellectual Property Office.

    Diabetic macular edema (DME - fluid leaking into the area of the retina that provides sharp vision directly in front of you) and the diabetic retinopathy (the actual breaking down of tissues in the retina due to Type 1/2 diabetes that leads to) which causes it, are a serious problem resulting in vision loss and eventually blindness. There is no effective daily drug treatment and retinopathy occurs in almost all Type 1 cases (over 60% in Type 2) other than to regulate the conditional parameters (controlling blood sugar, blood lipid levels, hypertension, and the like), which exacerbate the fundamental problem.

    Diabetic retinopathy is a massively underserved market that has exploded alongside the global diabetes epidemic, with the only options being unavailable in US/Canada and piecemeal at best (laser therapy and injection/implantation of drugs to/around the tissues).

    So here is Optina, an ultra-low dose oral capsule form of danazol (the biphasic effect of which has been shown in endothelial cell permeability and f-actin cytoskeleton dynamics - Biochemical Biophysical Research Communications, Apr 2012), which basically tightens up the tissues that otherwise degrade. This biphasic effect of danazol (increasing or decreasing permeability at lower or higher concentrations) detailed in the BBRC publication (the first of what is to be a series), allows for modulated permeability. The mode of action then in Optina is essentially a modulation of the F-actin endoskeleton of the endothelial cells (which line the inside of blood vessels in the retina), resulting in better overall cohesion to the peripheral, or cortical actin, meaning the cell junctions are tight and leakage is reduced or eliminated.

    AMPE has secured its footprint for Optina in North America with this move and has the requisite global patent ball rolling as well, with multiple additional patents pending worldwide. Since danazol (a derivative of the synthetic steroid ethisterone) was approved by the FDA back in the 1970s (for endometriosis, and more recently for chronic indications like fibrocystic disease of the breast, hereditary angioedema, and ITP), there is a very solid grounding for acceptance of the associated vascular dynamics.

    CEO of AMPE, Michael Macaluso, emphasized the uncontested position of the drug, with no other oral drug being commercially available, or even known to exist for treatment of this condition. Macaluso cited the "unusually long" patent life spans granted (doesn't expire until 2030), contrasting them with most other drugs at the same position on the timeline, just before a pivotal clinical trial, and staring at the very end of their patent life rapidly approaching like a freight train. Macaluso commented on ongoing discussions with potential partners to co-develop Optina, clearly excited about the DME potential and huge, underserved/unnerved market full of people who are at risk of going blind without such innovative products.

    Chief Regulatory Officer at AMPE, Dr. Vaughan Clift, underscored the significance of the double masked, placebo controlled clinical study of Optina at Saint Michael Hospital in Toronto, which validated the in vitro findings regarding the extremely valuable function of a low dosage, as well as the inverse effect from a high dosage. The CRO is completely vetting the data from the Optina trial and AMPE intends to publish results via the proper venues after meeting with FDA to do a pre-IND run down of pivotal trials in the U.S. under 505(b)2 registration.

    For more information on today's patent announcement, or to stay up to date with the latest results out of this constantly innovating biopharma, please visit the Ampio Pharmaceuticals, Inc. website at: www.AmpioPharma.com

    Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html

    Tags: AMPE
    Apr 27 6:09 PM | Link | Comment!
  • Simulations Plus, Inc. (SLP) Releases Version 8.0 Of Its Best-in-Class GastroPlus Simulation Software

    Simulations Plus today announced it has released Version 8.0 of GastroPlus, its flagship simulation software. GastroPlus 8.0 features significantly enhanced functionality and user convenience, representing a substantial upgrade of the company's industry-leading drug absorption, pharmacokinetics, and pharmacodynamics simulation software.

    Among the features of GastroPlus 8.0 is the ability to simulate both inhibition and induction of transporters and enzymes in any tissue, as well as the ability to specify dissolution rates as function of pH, including fitting "Z Factor" from multiple in vitro dissolution experiments at different pH. GastroPlus 8.0 also enables enhanced modeling of drug absorption and distribution for ocular and pulmonary delivery, and the system features the addition of a paracellular permeability model that specifically accounts for drug movement between the epithelial cells lining the intestinal wall and transport into and through cells. The software comes equipped with an enhanced PDPlus module for building pharmacodynamics models and predicting pharmacodynamics effects for new doses and dosage forms, and it also features an expanded library of animal physiologies and expanded outputs for the Population Simulator. An increased execution speed and a number of user-convenience features and "sanity checks" round out the enhanced GastroPlus 8.0 software.

    GastroPlus 7.0 was released in August 2010. The updated 8.0 version represents a combination of features requested by industry scientists as well as Simulations Plus' own design. GastroPlus is utilized by the world's top 20 pharmaceutical companies as well as many small and medium-sized companies across the globe.

    Headquartered in California, Simulations Plus is a leading developer of pioneering drug discovery and development simulation and modeling software, which is licensed and used for conducting drug research by major pharmaceutical, biotechnology, chemical, and food processing companies around the world. For more information, visit www.simulations-plus.com

    Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html

    Tags: SLP
    Apr 27 6:08 PM | Link | Comment!
  • American Apparel, Inc. (APP) Launches Online Store In Hong Kong

    On Thursday, Los Angeles-based clothing manufacturer American Apparel announced that it has launched a new online store that will service Hong Kong. The regional web store will be the company's first direct e-commerce portal for its customers in Hong Kong. The new website is located at store.americanapparel.com.hk. Prior to the launch of this new site, customers shopped through the company's international e-commerce store. Over time, Hong Kong had become the highest-performing international region without its own dedicated site.

    In creating the new web store, the company will enhance its ability to serve consumers in the region in a number of new ways. To begin with, the site will accept orders placed in Hong Kong dollars. It will also allow for localization based on Hong Kong's seasonal patterns and its schedule of holidays. While orders will still be fulfilled from the company's Los Angeles-based factory, the move to the new store will decrease shipping costs for Hong Kong shoppers by $10 USD and will provide even better and timelier customer service.

    Dov Charney, American Apparel founder and CEO, remarked, "Hong Kong is one of the most exciting regions in the world to run a business and we're proud to expand our presence in the area. The parallels between American Apparel and Hong Kong itself-both founded on a bedrock of capitalism and free trade-are obvious and I think they'll only help us in our exploration of this vibrant market."

    "We're thrilled to offer our fans in Hong Kong their own local web store. We saw a fantastic opportunity to better serve our current clientele and hone our message to the region's potential new customers," added Christina Naetscher, web director for American Apparel.

    To learn more about the company, visit www.americanapparel.net

    Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html

    Tags: APP
    Apr 27 1:43 PM | Link | Comment!
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