Post by Randy on Nov 15, 2011 0:10:25 GMT -5
Certainly someone else has seen this SD Foundation ELetter post this week. Any comments?
Randy
---------------------------
Daval International announces positive Phase II results for AIMSPRO® as a monotherapy in
Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
Eastbourne, UK – Daval International 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.
About AIMSPRO®
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 neurodegenerative,
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, www.davalinternational.com/. The company encourages all interested parties to
consult these sections for more information on Daval and its business.
Randy
---------------------------
Daval International announces positive Phase II results for AIMSPRO® as a monotherapy in
Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
Eastbourne, UK – Daval International 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.
About AIMSPRO®
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 neurodegenerative,
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, www.davalinternational.com/. The company encourages all interested parties to
consult these sections for more information on Daval and its business.
