Navigation Links
Daval International Announces Positive Phase II Results for AIMSPRO® as a Monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)

EASTBOURNE, England, October 10, 2011 /PRNewswire/ --

Daval International today announced positive results from its Double-Blind Placebo-Controlled Phase II Clinical Study evaluating the safety and tolerability of AIMSPRO given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma).  The study evaluated the effects of 4.5mg/ml doses of AIMSPRO, administered subcutaneously, twice weekly for 26 weeks compared with placebo.

The primary endpoint of the study was to evaluate the safety and tolerability of AIMSPRO in the treatment of twenty patients with Systemic Sclerosis (diffuse scleroderma) through a period of 26 weeks of study participation. The secondary outcome measures of the study were to assess the efficacy of AIMSPRO as a therapeutic agent for scleroderma using inter alia the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF-36 (Short form 36) and the MRC Sum Score.

Significantly, at the end of the 26 week period AIMSPRO proved it was a safe and well-tolerated medication when administered to these especially sick patients at such a late-stage of the disease. There was no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters that were measured. In addition to the positive safety result, there were encouraging signals of clinical benefit in the secondary outcome measures. The results for the Modified Rodnan Skin Score, a validated measure of disease severity, recorded a worsening in the patients receiving placebo (changes: -27.07%, p=0.29) whereas stability was noted on the patients on AIMSPRO treatment.  Furthermore, there was a distinct improvement in the overall SF-36 scores (changes: +41.6%, p=0.184) for the patients receiving AIMSPRO.

There were also trends towards benefit for lung function measures. The Forced Expiratory Volume in one second (FEV1) decreased in the placebo group as compared to baseline at 26 weeks (change: -5.6%; p=0.0582) with no such deterioration being observed in the AIMSPRO treated group. Similarly, the Forced Vital Capacity (FVC) was observed to decrease in the placebo group as compared to baseline at 26 weeks (change: -5.6%, p=0.1038), but not in the AIMSPRO treated group, where the FVC showed an increase (change:+1.8%, p=0.3225).

"Although requiring further confirmatory studies, these results are quite exciting, especially when compared to what has been seen in other pilot trials in scleroderma as there is a clear unmet medical need for patients suffering with this life-threatening disease" said Professor Christopher Denton, Professor of Experimental Rheumatology at the Royal Free Hospital in London, United Kingdom, the principal investigator for the trial. "The important value of the safety data from such a well-conducted trial in such a serious disease is clear, apart from the signals of therapeutic benefit."

Daval's Clinical and Scientific Director, Professor Syed Haq commented, "This study, conducted at one of the world's leading scleroderma centres, was an important first step towards understanding whether AIMSPRO could significantly help patients with diffuse scleroderma and potential overlapping connective tissue disorders, for which there is no cure, by arresting the disease even in its latter stages. AIMSPRO has been shown to be well-tolerated and safe and with the several positive therapeutic signals demonstrated, some of which were significant, it certainly warrants further investigation on a larger scale to determine the full efficacy of AIMSPRO in Late Stage Established Diffuse Cutaneous Systemic Sclerosis."

At the completion of the 26 week period of the study, AIMSPRO was offered to the patients on a compassionate use basis and the results from the 52 week visit will be presented as an addendum to the initial study report.

Daval is now assessing the biomarker data collected in this clinical trial and correlating this with the changes observed, so as to shed more light into the mechanism of action of AIMSPRO in the context of Late Stage Established Diffuse Cutaneous Systemic Sclerosis .

About the Study

This double-blind, randomised, placebo-controlled Phase 2a study of AIMSPRO enrolled twenty patients who received either AIMSPRO or placebo, 4.5mg/ml subcutaneously, twice weekly for 26 weeks. Standard outcome measures and novel biomarkers were used to investigate safety, efficacy and response to treatment.


AIMSPRO is a new generation treatment which combines the benefits of polyclonal antibody (PAb) technology with polypeptide components (PP). It is a pharmaceutically derived biological product that is manufactured and processed using a unique specification that is patent protected and which is derived from a caprine hyperimmune serum source that has been immunised with an inactivated HIV IIIB viral lysate.

About Scleroderma

Scleroderma is an autoimmune connective tissue disease affecting blood vessels and collagen production. It is more common in women than men. The cause is still largely unknown and although there is no cure, there are some treatments available that slow down or halt disease progression. There are two kinds of scleroderma: systemic sclerosis which affects the internal organs as well as the skin, and localised scleroderma which affects a specific area of skin but not the organs.

About Daval

DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of novel and distinctive treatments for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improves the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.

Daval routinely posts information and latest news, including press releases, which may be important to shareholders, health care professionals and patients in the News & Resources section of the company's web site, The company encourages all interested parties to consult these sections for more information on Daval and its business.

SOURCE Daval International
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
2. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
3. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
4. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
5. International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
6. Surface Logix Presents Positive Phase 1 Repeat-Dose Trial Data on SLx-4090 at The 16th International Symposium on Drugs Affecting Lipid Metabolism
7. Preclinical Data on Lead MEK Inhibitor, RDEA119, to be Presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
8. Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference
9. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
10. Survival Data for Avicenas Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium on ALS/MND
11. CEL-SCI CEO to Present at the International Society for Pharmaceutical Engineering 2007 Chesapeake BioShowcase
Post Your Comments:
(Date:11/25/2015)... 25, 2015 On Tuesday, November 24, ... trial against Wright Medical Technology, Inc. for product ... metal-on-metal hip implant device, awarded $11 million in ... week trial and three days of deliberations, the ... was defectively designed and unreasonably dangerous, and that ...
(Date:11/25/2015)... 25, 2015  Henry Schein, Inc., the world,s largest ... dental, medical and animal health practitioners, will unveil at ... Henry Schein ConnectDental® Pavilion , which brings together for ... solutions designed to help any practice or laboratory enter ... for a schedule of experts appearing at the Pavilion. ...
(Date:11/25/2015)... plc (NYSE: AGN ) today announced that it has ... Attorney General,s Office to end the litigation under ... the Attorney General over the decision of Forest Laboratories, Inc., ... now generic version of memantine immediate release tablets.  Under the ... counterclaims against New York , and has ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 27, 2015 , ... The rapid speed at which Americans ... more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming ... The forgotten part of this equation: 80 percent of medical care occurs in ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When I was traveling, I ... Hillside, N.J. "Many people catch diseases simply from sitting on such dirty toilet ... protected from germs." , He developed the patent-pending QUDRATECS to eliminate the need ...
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion is ... Pro X. With ProSidebar: Fasion, video editors can easily add an informative sidebar ... minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and text ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec Solutions announced today that ... (MSDSLUG). Recognized as Microsoft’s official group for end users of Dynamics SL ERP ... partners, industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ongoing commitment ...
(Date:11/27/2015)... ... 27, 2015 , ... Keeping in mind challenges faced by ... wellness consultation, has collaborated with a leading web-based marketplace for extra-curricular activities for ... parents and bring advice from parenting experts within their reach. As a part ...
Breaking Medicine News(10 mins):