Daval International announces positive Phase II results for AIMSPRO® as a monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)

October 31, 2013

Eastbourne, UK – 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 (dSSc).  The study evaluated the effects of 4.5mg/ml doses of AIMSPRO, administered subcutaneously, twice weekly for 26 weeks compared with placebo and has been recently published in Annals of Rheumatic Diseases (http://ard.bmj.com/search?fulltext=hyperimmune&submit=yes&x=0&y=0).

The primary endpoint of the study was to evaluate the safety and tolerability of AIMSPRO in the treatment of twenty patients with dSSc 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 (mRSS), the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF-36 (Short form 36) and the MRC Sum Score.

A successful double-blind placebo-controlled phase II clinical trial in dSSc involving 20 patients was completed in the UK. Analysis of results from the double-blind phase (DBPC) arm and subsequently of the open label (extension-arm) phase of the trial showed statistical and near statistical significant changes in key clinical outcomes with active treatment, such as a reduction in the mRSS (p=0.041, on post-hoc analysis, paired t-test) with 26 weeks of treatment, and in the DBPC phase; a responder rate of 50% (AIMSPRO) vs. 10% (placebo) [p<0.061] was noted; improved Forced Vital Capacity [FVC] (p=0.029, one tailed paired t-test); Forced Expiratory Volume in 1 second [FEV1] (p=0.079) and in the Neuropathic Visual Analogue Scale (VAS) (p=0.046) were additional efficacy outcomes.

Importantly, in this fragile patient population no treatment-related serious adverse or adverse events were recorded during the entire duration of the trial. There was no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters that were measured. To the positive safety results, there was a distinct improvement in the overall SF-36 scores (changes: +41.6%, p=0.184) for the patients receiving AIMSPRO.

“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 centers, 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 efficacy signals demonstrated. Further investigation is warranted now 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 thereafter collated. Daval is now preparing to publish several follow-up publications on the biomarker findings from the 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. This will be further supported by results from multiple in vivo bleomycin murine models of fibrosis.

About the Study

This double-blind, randomised, placebo-controlled Phase IIa 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.

About AIMSPRO®

AIMSPRO is a new generation treatment that combines the benefits of polypeptide technology. 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 immunized 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, http://www.davalinternational.com/. The company encourages all interested parties to consult these sections for more information on Daval and its business.

 

 

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