Navigation Links
Pharmos Announces Clinical Results from Phase 2a Trial of Topical Diclofenac NanoEmulsion Cream

Study did not achieve statistical significance

ISELIN, N.J., Nov. 19/PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS) today announced results from its Phase 2a clinical trial of its topical NanoEmulsion (NE) drug delivery technology formulated with 3% Diclofenac Diethanolamine.

The multi-center, randomized, double-blinded, placebo-controlled study evaluated the safety and efficacy of the Company's 3% Diclofenac Diethanolamine NanoEmulsion cream in 104 patients with chronic pain due to osteoarthritis of the knee. Patients applied the topical cream three times daily for 28 days.

The study did not achieve statistical significance in its primary efficacy endpoint, nor in several secondary endpoints. The effect witnessed did not measure up to other topical NSAID (non-steroidal anti-inflammatory drug) products already approved or currently in development in the US.

This study confirmed the safety of the 3% NanoEmulsion Diclofenac Diethanolamine cream previously demonstrated in the Phase I study. The majority of the reported adverse events (AE's) were defined as mild in severity and most of them were regarded by the investigators as not drug related. No Serious AE's were reported and the effect of the NanoEmulsion cream on the skin was minimal.

Pharmos has decided to discontinue its topical NanoEmulsion drug delivery program. The Company's operations in Israel were closed effective October 31, 2008, and the Company is seeking to license / partner its only remaining program -- the CB2 Selective Agonist program targeting pain and inflammation. No further development work is being conducted on that program.

The Company is focusing all its resources on its Dextofisopam clinical trial for Irritable Bowel Syndrome (IBS) currently enrolling in a 480 patient Phase 2b trial.

About Pharmos Corporation

Pharmos discovers and develops novel therapeutics to treat a range of indications including specific diseases of the nervous system such as disorders of the brain-gut axis (IBS), pain/inflammation, and autoimmune disorders. The Company's lead product in development, dextofisopam, is undergoing Phase 2b testing in IBS patients. Dextofisopam has completed a Phase 2a IBS study in which it demonstrated a statistically significant effect compared to placebo on the primary efficacy endpoint of adequate relief (n=141, p=0.033). The Company also has a proprietary technology platform focusing on discovery and development of synthetic cannabinoid compounds with a focus on CB2 receptor selective agonists. Various CB2-selective compounds from Pharmos' pipeline have completed preclinical studies targeting pain, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease and other disorders. These are available for licensing / partnering.

SafeHarbor Statement

Statements made in this press release related to the business outlook and future financial performance of Pharmos, to the prospective market penetration of its drug products, to the development and commercialization of its pipeline products and to its expectations in connection with any future event, condition, performance or other matter, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos' filings with the Securities and Exchange Commission could affect such results.

SOURCE Pharmos Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Celator(R) Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study with CPX-351
2. Portola Announces Data Showing Its Anti-Platelet Drug Inhibits Platelets in Clopidogrel (Plavix(R)) Non-Responders
3. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
4. Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease
5. Raptor Pharmaceuticals Corp. Announces Positive Phase IIa Clinical Study Results for Convivia(TM) Program
6. Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
7. Diagenic Announces Launch of First Breast Cancer Gene-Expression Blood Test
8. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
9. Celladon Announces Presentation of Clinical Data From First-in-Human MYDICAR(R) Trial for Advanced Heart Failure at American Heart Association Scientific Sessions
10. Portola Announces Data Presentations Relevant to Its Lead Phase II Antithrombotic Compounds at American Heart Association Scientific Sessions 2008
11. Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin
Post Your Comments:
(Date:11/26/2015)... 2015 --> ... combineert immunotherapie met Bremachlorin-photodynamische therapie voor de ... ) --> ... ) Uit een ... (LUMC) blijkt dat ...
(Date:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Therapeutic Drug Monitoring (TDM) Market: Supplier ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare ... participated in the 61st annual Employee Benefits Conference. The Employee Benefits Conference was ... November 8th through Wednesday, November 11th, 2015. The conference was held at the ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... has collaborated with Women’s Web – an online resource for Indian women ... mental and emotional well-being relationship, life balance, stress, professional development, and lifestyle. ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... more aggressive than those found on mammography, according to a study published online ... additional cancers not seen on mammography may necessitate a change in treatment. , ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday season ... and pleasing the palates of attendees is of the utmost importance. Whether you ... seasonal get-together, give these recipes a try this holiday season. , Turkey Croquettes ...
(Date:11/25/2015)... ... November 25, 2015 , ... Medical Solutions, one ... for its stellar workplace culture with the company’s Cincinnati office being named a ... Cincinnati office was named a finalist in Cincinnati Business Courier’s 13th annual Greater ...
Breaking Medicine News(10 mins):