Patients with marked bladder dysfunction as a result of secondary progressive multiple sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in this double-blind crossover study.

Start Date01 May 2009

Sponsor / Collaborator

Daval International Ltd.

NCT00769028

/ Unknown statusPhase 2

A Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.

Start Date01 Dec 2008

Sponsor / Collaborator

Daval International Ltd.

EUCTR2007-003122-24-GB

/ Not yet recruitingPhase 2

A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis

Start Date09 Apr 2008

Sponsor / Collaborator

Daval International Ltd.

100 Clinical Results associated with Daval International Ltd.

0 Patents (Medical) associated with Daval International Ltd.

Literatures (Medical) associated with Daval International Ltd.

01 Jun 2014·Annals of the Rheumatic Diseases

AB0213 A Stabilised-Release Neuropeptide Functions as A Novel Cutaneous Anti-Fibrotic Agent

Author: M. Haq ; J. Vernes ; K. Etzel ; S. Haq ; J. Woloszynek ; H. Lopez ; D. McIntosh ; C. Moore

Background Stabilized-release caprine corticotrophin releasing hormone-1 (SR-CCRH-1) is held in a multi-protein complex and derived from hyperimmune caprine sera (HICS). SR-CCRH-1 may have an efficacy trait and accordingly warranted investigation. Objectives The objective of the study was to determine whether a novel stabilized-release caprine corticotrophin releasing hormone-1 (SR-CCRH-1) neuropeptide could elicit measurable efficacy as an anti-fibrotic agent in the murine bleomycin (BLM)-induced skin fibrosis model (an in vivo study model used to demonstrate the therapeutic effects of test articles on cutaneous fibrosis and inflammation). Methods For this study, age-sex-matched C57BL/6 male and female mice, n=8-12 per treatment group (saline control, naive serum control, bleomycin/saline, bleomycin/naive and bleomycin/SR-CCRH-1), were injected daily with (100 μg s.c.) of SR-CCRH-1 or naive serum in the respective group using a double-blind experimental protocol for 50 days. Study mice were administered with 0.09 units of BLM in 50 μl volume by s.c. injection on alternate days for 50 days. Results The results showed that on examination of immunohistochemical staining of skin biopsies [taken from sections from each group (n=6)] using H&E, Masson9s Trichrome, a-skeletal muscle actin and thrombin, that SR-CCRH-1 significantly inhibited cutaneous fibrosis (p A significant increase in a-melanocyte-stimulating hormone (p=0.003), a cleavage product of pro-opiomelanocortin was also noted. The mechanism of action appeared to revolve around a CRH-1- (p=0.0027) and not CRH-2-mediated response. Skin homogenates showed that MC-4R a target of a-MSH (but not MC-1R) appeared to be significantly involved as a downstream target (p=0.017). MMP-9 (p=0.019), MMP-1 (p=0.058), MMP-13 (p=0.038) and PIIINP (p Conclusions The study taken together provides a novel targeted approach that focused on the CRH-1 receptor expressed in the skin and hypothalamo-pituitary-adrenal axis that led to a cascade of changes highlighted by abrogation of inflammation and cutaneous fibrosis. SR-CCRH-1 may serve as a potential therapeutic in the treatment of cutaneous fibrotic disease. To that end, in a recently completed phase II double blind placebo controlled trial in established late-stage diffuse systemic sclerosis using SR-CCRH-1 pointed to an efficacy signal with reduced a Modified Rodnan Skin Score, and a favourable safety/tolerability profile. Disclosure of Interest J. Woloszynek: None declared, K. Etzel: None declared, J. Vernes Employee of: employee, D. McIntosh Shareholder of: Shareholder, Consultant for: Consultant, C. Moore Shareholder of: Shareholder, M. Haq Shareholder of: Shareholder, H. Lopez: None declared, S. Haq Shareholder of: Director DOI 10.1136/annrheumdis-2014-eular.5868

01 Jun 2014·Annals of the Rheumatic Diseases

AB0214 A Stabilized Neuropeptide Immunotherapy Abrogates Bleomycin-Induced Pulmonary Fibrosis

Author: M. Haq ; J. Vernes ; K. Etzel ; S. Haq ; J. Woloszynek ; H. Lopez ; D. McIntosh ; C. Moore

Background Stabilised caprine corticotrophin releasing hormone is long acting neuropeptide that targets its cognate receptor in the skin and hypothalamus. Objectives The aim of this study was to examine the role of stabilized-release caprine corticotrophin releasing hormone-1 (SR-CCRH-1) an extract from hyperimmune caprine sera (HICS) could act as an anti-fibrotic agent in the murine bleomycin (BLM)-induced pulmonary fibrosis model. Methods Two parallel studies were used; one functional and the other pathology-based, using age-matched C57BL/6 male and female mice, n=8-12 per treatment group (saline control, naive serum control, bleomycin/saline, bleomycin/naive and bleomycin/SR-CCRH-1), were injected daily with (100 μg s.c.) of SR-CCRH-1 or naive serum in the respective group using a double-blind experimental protocol from day 7 post-BLM gavage until day 28. Study mice were administered with 0.09 units of BLM in 50 μl volume by gavage at the start of the study on day 1. Results The results showed on immunohistochemical staining of lung biopsies [multiple sections taken per group (n=6)] using H&E, Masson9s Trichrome indicated that SR-CCRH-1 significantly inhibited pulmonary fibrosis (p=0.019) and significantly reduced the inflammatory cellular infiltrate and alveolar macrophage infiltrate in the BLM/SR-CCRH-1 group relative to all control groups. ELISA studies from pulmonary homogenates further confirmed and showed that SR-CCRH-1 significantly reduced PIIINP levels (p=0.0437) in the lung of animals treated with BLM. ELISA studies on serum taken from the study groups further confirmed significant inhibition of IL-12p70 (p=0.046), MMP-9 (p=0.047), but not of MMP-13 (p=0.658). Bronchoalveolar lavage showed significant inhibition of the monocyte chemo-attractant protein-1 (MCP-1) in the SR-CCRH-1 versus BLM/vehicle controls (p=0.039). A separate body plethsmography study using the BUXCO system was used to determine the pulmonary lung function of animals at day 10 and 28 days during the study. Animals were exposed to either air or a 5% CO2 stress-challenge. Significant maintenance of lung function in the BLM/SR-CCRH-1 group compared to the BLM/naive serum group but importantly, comparable to the naive serum control group was noted, as measured by changes in the minute volume (p=0.003), tidal volume (p=0.008) but not frequency when animals were exposed to a 5% CO2 challenge at 28 days. The results indicate that SR-CCRH-1 blocked significantly the functional and pathological deterioration associated with BLM-induced pulmonary fibrosis. The study taken together provide a novel targeted approach that focused on the CRH-1 receptor in the lung parenchyma and hypothalamo-pituitary-adrenal axis that lead to augmentation of pulmonary fibrosis. Conclusions To that end, in a recently completed phase II double blind placebo controlled trial in established late-stage diffuse systemic sclerosis using SR-CCRH-1 pointed to an efficacy signal with improved pulmonary FVC in the active treatment arm, and a favourable safety/tolerability profile. Disclosure of Interest J. Woloszynek: None declared, K. Etzel: None declared, J. Vernes Employee of: employee, D. McIntosh Shareholder of: Shareholder, Consultant for: Consultant, C. Moore Shareholder of: Shareholder, M. Haq Shareholder of: Shareholder, H. Lopez: None declared, S. Haq: None declared DOI 10.1136/annrheumdis-2014-eular.5969

100 Deals associated with Daval International Ltd.

100 Translational Medicine associated with Daval International Ltd.

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