Navigation Links
Dipexium Pharmaceuticals Updates Locilex™ Development Activities and Announces 2011 Milestones
Date:4/4/2011

NEW YORK, April 4, 2011 /PRNewswire/ -- Dipexium Pharmaceuticals today provided an update of its development activities and announced its milestones to be achieved during 2011. Management announced that it has completed successfully initial six-months' stability testing on the original formulation of Locilex™ (pexiganan acetate 1% cream) and has moved on with its manufacturers to expand the batch size for clinical and commercial production.  In addition, the Company has received formal and clear clinical guidance from the FDA to support its Phase 3 clinical and regulatory pathway to resubmission of its new drug application (NDA) for Locilex™ in the U.S.

The Company also announced that its critical milestones for 2011 include the following:

  • Manufacturing:  The Company anticipates completing the work required to support its chemistry, manufacturing and controls (CMC) meeting with FDA in May 2011;
  • CMC Meeting:  The Company anticipates convening a CMC meeting with FDA in August 2011 to finalize the Company's manufacturing plans and use of product supply in the upcoming Phase 3 program;
  • Special Protocol Assessment (SPA) Filing:  The Company intends to file for a SPA designation in September 2011 shortly after the tentatively planned scheduled CMC meeting.

"Successfully achieving these value-inflection points should significantly reduce the risk associated with completing the drug development of Locilex™ and position the Company for further financing or other strategic alternatives," stated David P. Luci, Co-Founder & Managing Partner.

About Dipexium:

Dipexium Pharmaceuticals, LLC is an emerging biopharmaceutical company initially formed to complete the development and initiate the commercialization of Locilex™ (pexiganan acetate 1% cream), a novel, small peptide anti-infective agent. Locilex™ is formulated
'/>"/>

SOURCE Dipexium Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. OncoSec Medical Closes Purchase and License Agreement for Tumor Therapy Technology with Inovio Pharmaceuticals
2. Optimer Pharmaceuticals Announces Presentation at SHEA of Data Highlighting the Burden of Clostridium difficile Infection (CDI) in Hospital Patients
3. Ampio Pharmaceuticals, Inc. Announces Appointment of New Chief Financial Officer to be Effective April 4, 2011
4. Conatus Pharmaceuticals Presents Results From a Phase 2 Clinical Trial of CTS-1027 in HCV Genotype 1 Null-Responders
5. Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis
6. Reportlinker Adds Top 500 Pharmaceuticals Industry Report (Global)
7. Reportlinker Adds Top 200 Biopharmaceuticals Industry Report (Global)
8. Syndax Pharmaceuticals Announces Entinostat Data at 102nd Annual American Association for Cancer Research Meeting
9. Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression
10. Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results
11. Merz Pharmaceuticals Announces New Centers for Medicare and Medicaid Billing Q-Code for Xeomin® (incobotulinumtoxinA)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... 25, 2014 Leading events organizer UBM ... for the seventh year to São Paulo, Brazil ... August 2014. The event will co-locate with Food Ingredients South ... comprehensive meeting point for the pharmaceutical industry.      ... for pharmaceutical sales are now exploring the South ...
(Date:7/25/2014)... BOHEMIA, N.Y. , July 25, 2014 /PRNewswire-iReach/ -- Dr. ... Pediatrics clinic, GPM Pediatrics, reacts to a recent study, ... adulthood. Photo - http://photos.prnewswire.com/prnh/20140723/129709 ... mothers exposed to severe stress are more likely than others ... occurred months before pregnancy." There were two specific ...
(Date:7/24/2014)... , July 24, 2014  PTC Therapeutics, Inc. ... Company will host a webcast conference call to report ... update on the company,s business and outlook on Thursday, ... opening of the market. The call ... (973) 935-8152 (international) five minutes prior to the start ...
Breaking Medicine Technology:CPhI South America 2014 Launches with Generics Showing Huge Growth 2CPhI South America 2014 Launches with Generics Showing Huge Growth 3CPhI South America 2014 Launches with Generics Showing Huge Growth 4Dr. Michael Gabriel of GPM Pediatrics, a Noted Staten Island Pediatrics Clinic, Comments on Study, Which Names Grief as a Cause of Obesity in Children 2
... 24, 2011 Reportlinker.com announces that a new market ... Therapeutics for Immune System Disorders ... the global market for drugs for the treatment of ... The market size is forecast to grow at a ...
... March 24, 2011 Tarsa Therapeutics today announced that ... salmon calcitonin in the treatment of postmenopausal osteoporosis was ...  The results will be used to support a New ... Administration (FDA) targeted for the fourth quarter of 2011, ...
Cached Medicine Technology:Reportlinker Adds Therapeutics for Immune System Disorders 2Reportlinker Adds Therapeutics for Immune System Disorders 3Reportlinker Adds Therapeutics for Immune System Disorders 4Reportlinker Adds Therapeutics for Immune System Disorders 5Reportlinker Adds Therapeutics for Immune System Disorders 6Reportlinker Adds Therapeutics for Immune System Disorders 7Reportlinker Adds Therapeutics for Immune System Disorders 8Reportlinker Adds Therapeutics for Immune System Disorders 9Reportlinker Adds Therapeutics for Immune System Disorders 10Reportlinker Adds Therapeutics for Immune System Disorders 11Reportlinker Adds Therapeutics for Immune System Disorders 12Reportlinker Adds Therapeutics for Immune System Disorders 13Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 2Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 3Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 4
(Date:7/25/2014)... that controls when genes are switched on or off ... brain to regulate metabolism, UT Southwestern Medical Center researchers ... therapies to treat obesity and diabetes, since the transcription ... appears to influence the body,s sensitivity to insulin ... to the body,s regulation of food intake and sugar ...
(Date:7/25/2014)... The American Brain Tumor Association (ABTA) today unveiled branding ... annual patient and family conference in Chicago. , “This ... as we – the first and now only national ... brain tumor research – extend our reach by engaging ... getting our materials and services into the hands of ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 Progress in ... in a new era of promising brain tumor treatments, ... Medical School, director of the Center for Neuro-Oncology, Dana-Farber ... (ABTA) annual Patient and Family Conference in Chicago, July ... science and new technology are impacting the development of ...
(Date:7/25/2014)... Splashtop, Inc. announced that it has ... Business and Splashtop Enterprise will now be featured in ... MaaS360 WorkPlace SDK to enable enterprise-grade security controls for ... Enterprise offer secure remote access, support, and colloaboration for ... ease of use, collaborative features, and support for both ...
(Date:7/25/2014)... Garth Brooks Chicago tickets go on sale Friday, July ... Garth Brooks was one of the leaders on the country music ... Since "Much Too Young (To Feel This Damn Old)" was released, ... native and in the years that he has been away from ... and in the recording studio. Between 2001 and 2009, fans heard ...
Breaking Medicine News(10 mins):Health News:Manipulating key protein in the brain holds potential against obesity and diabetes 2Health News:American Brain Tumor Association Unveils Brand Identity for Newly Launched Volunteer Network 2Health News:American Brain Tumor Association Unveils Brand Identity for Newly Launched Volunteer Network 3Health News:Immunotherapy, Targeted Molecular Therapies Among Promising New Treatments for Brain Tumors 2Health News:Immunotherapy, Targeted Molecular Therapies Among Promising New Treatments for Brain Tumors 3Health News:Immunotherapy, Targeted Molecular Therapies Among Promising New Treatments for Brain Tumors 4Health News:Splashtop Joins the MaaS360 WorkPlace Partner Program 2Health News:Splashtop Joins the MaaS360 WorkPlace Partner Program 3Health News:Splashtop Joins the MaaS360 WorkPlace Partner Program 4Health News:Garth Brooks Chicago Tickets for Performance at Allstate Arena in Rosemont Go On Sale July 25th 2Health News:Garth Brooks Chicago Tickets for Performance at Allstate Arena in Rosemont Go On Sale July 25th 3
... Robotic Urology Symposium+2011 will take place Jan. 13-16, 2011 ... numerous 3D and 2D surgeries (each morning), observing differences ... United States and abroad. , Lectures and plenary sessions ... as well as alternatives therapies to treat patients with ...
... receiving the appropriate training and support they need to help ... and inadequate levels of care. Those are the key ... specialists from the University of Nottingham, UK, and published in ... Mental Health Nursing. Staff nurse Jo McHale and ...
... About ten years ago, the discovery of microRNAs ― ... unlocked a world of scientific possibilities, including a deeper ... "deep sequencing," which gives scientists the ability to discover ... Now, Tel Aviv University researchers have developed the cutting-edge ...
... whose partners have breast cancer are at increased risk of ... hospitalization. Published early online in Cancer , a peer-reviewed ... clinicians should address the mental health of cancer patients, loved ... not only affected patients but of their closest relatives as ...
... By Steven Reinberg HealthDay Reporter , ... United States are not drinking as much water as ... a new study suggests. "Even mild dehydration can ... and dry mouth," said Samantha Heller, clinical nutrition coordinator ...
... Dennis Thompson HealthDay Reporter , FRIDAY, Sept. 24 ... diseases on the planet, and the second leading cause of ... slowly conquering cancer, according to an assessment of cancer trends ... the U.S. Centers for Disease Control and Prevention, the American ...
Cached Medicine News:Health News:Medical profession needs special training to handle self-harm, says international review 2Health News:Medical profession needs special training to handle self-harm, says international review 3Health News:Diving deeper into the gene pool 2Health News:Partners of breast cancer patients are at risk of developing mood disorders 2Health News:U.S. Kids Drink Too Little Water: Study 2Health News:U.S. Kids Drink Too Little Water: Study 3Health News:As Science Unlocks Secrets, Cancer Rates Fall 2Health News:As Science Unlocks Secrets, Cancer Rates Fall 3Health News:As Science Unlocks Secrets, Cancer Rates Fall 4
... range of automatic systems for performing erythrocyte ... of blood. With the introduction of the ... diagnostic market a truly revolutionary testing system ... associated with the traditional ESR techique.,By means ...
... of automatic systems for performing erythrocyte sedimentation ... blood. With the introduction of the Ves-matic ... market a truly revolutionary testing system which ... with the traditional ESR techique.,By means of ...
... VACUETTE® erythrocyte sedimentation rate analysers, ... The new generation unites the well-established ... whole range of additional innovations which ... erythrocyte sedimentation rate. Cost effectiveness is ...
Blood sedimentation rate analysis...
Medicine Products: