Navigation Links
Cerimon Pharmaceuticals Initiates Phase I Clinical Study of Topical Diclofenac Sodium Patch
Date:10/2/2007

Diclofenac Patch is Second Cerimon Product Candidate to Enter Clinical

Studies in 2007

SOUTH SAN FRANCISCO, Oct. 2 /PRNewswire/ -- Cerimon Pharmaceuticals, Inc., announced today it has initiated a Phase I clinical study of a novel diclofenac sodium patch, the Company's lead pain asset. The study will evaluate safety, tolerability, and systemic pharmacokinetics of a topical patch formulation of diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID), in 16 healthy volunteers. The Phase I study is expected to be completed in the fourth quarter of 2007. Following the completion of this study, Cerimon plans to rapidly initiate late-stage efficacy and safety studies of its diclofenac sodium patch in patients with acute musculoskeletal pain.

"Topical diclofenac is the second therapeutic product Cerimon has advanced into clinical studies this year, following the initiation of Phase IIb testing for Simulect(R) (basiliximab) in the first quarter," stated Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "We are proud of this progress and believe the diclofenac patch will address the market need for safe and effective topical pain therapies. Currently, topical NSAIDs are marketed in Europe, Japan, and other parts of the world, but not in the U.S. Their advantage in treating musculoskeletal pain is the ability to deliver drug directly to the affected area with minimal systemic exposure. Given the systemic side effects of traditional non-topical NSAIDs, as well as the withdrawal of some COX-2 inhibitors, we believe developing a new treatment option is an important goal for the medical community."

Pain Market

Musculoskeletal pain is pain that affects the muscles, ligaments, and tendons. Acute musculoskeletal injuries are common and can occur during sports activities, exercise, or other physical activities. They often result in pain due to soft tissue injuries, such as sprains, strains, and minor contusions. While usually not serious, these injuries are often painful and result in temporary disability. Acute musculoskeletal injuries generally require rapid treatment. Primary treatment with cold compresses is often supported by administration of anti-inflammatory drugs. Optimal topical treatment should relieve acute pain and reduce swelling in the injured area to restore normal movement. In addition, it should be safe and easy to administer.

Pain represents a large and dynamic market in the U.S. Oral formulations of NSAIDs currently are marketed worldwide for the treatment of inflammation and pain, including pain due to musculoskeletal injuries, signs and symptoms of osteoarthritis and rheumatoid arthritis, menstrual cramps, headache and other minor aches and pains. While traditional oral NSAIDs are effective, they can cause serious gastrointestinal and other adverse events. Further, the withdrawal of some COX-2 inhibitors has removed a major therapeutic option for patients with multiple moderate and severe forms of pain, resulting in a significant market opportunity. These developments have created a significant need for a localized pain product with a strong safety profile.

About Cerimon Pharmaceuticals

Cerimon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to developing and commercializing therapeutic products for autoimmune diseases, inflammation and pain. Cerimon believes these new treatment options will enable physicians specialized in treating these conditions to further improve the lives of their patients.

Cerimon currently has two drugs in development. Simulect(R) (basiliximab) entered a Phase IIb study for moderate-to-severe steroid-refractory ulcerative colitis in the first quarter of 2007, and the Company now has initiated a Phase I study of a topical patch formulation of diclofenac sodium. This study will rapidly be followed by late-stage efficacy and safety studies in patients with acute musculoskeletal pain.

Cerimon is well financed, having closed a $70 million Series A financing in late 2005 with the premier investors MPM, Nomura Phase4 Ventures, and OrbiMed Advisors.

For more information on Cerimon, please visit the Company's website at http://www.cerimon.com.


'/>"/>
SOURCE Cerimon Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. 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
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
6. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
7. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
8. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
Breaking Medicine News(10 mins):