EDMONTON, May 7, 2012 /CNW/ - Medwell Capital Corp. (TSXV: MWC) today advised that Dr. Karen Meerovitch, Senior Director of Drug Discovery at Mimetogen Pharmaceuticals presented the Company's recent Phase II results for MIM-D3 in the treatment of Dry Eye disease in a poster session during the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The poster is entitled "Safety and Efficacy of Topical Ophthalmic MIM-D3, a novel TrkA Receptor Agonist, in a Phase 2 Clinical Trial for the Treatment of Dry Eye." The ARVO conference is one of the most widely attended conferences in the fields of vision and ophthalmology and is being held from May 6-10, 2012 in Fort Lauderdale, Florida.
"The trial demonstrated very strong results, with statistically significant improvements in both signs and symptoms at both the low (1%) and high (5%) doses of MIM-D3, together with excellent safety and tolerability profiles," said Kevin Giese, President and CEO of Medwell Capital Corp. "These results, together with comments received by Mimetogen at its end-of-phase II meeting with the FDA, have given the company confidence to take the technology forward into late stage clinical trials. In this regard, Mimetogen has retained a third party advisor to assist it in exploring its various strategic options, including the potential for partnering activities."
"To put the results into perspective, one potential path to regulatory approval in the U.S. is to demonstrate efficacy on both a sign (such as corneal sequelae as evidenced through various staining methodologies) and a symptom (such as dryness, discomfort etc.)," said Garth Cumberlidge, President of Mimetogen. "This trial was impressive in that it not only demonstrated efficacy on both criteria, but the effects were even more pronounced (p<0.05 in both doses) in those dry eye patients who entered the trial with typical dryness or other symptomatic problems."
As disclosed in its public filings, Medwell Capital owns approximately 12.4% of Mimetogen on a fully diluted basis, and its president Kevin Giese is a member of the board of Mimetogen.
The top line results of the trial were first reported by Mimetogen in June 2011. A summary of the more detailed results presented at the ARVO conference may be found below:
Phase II Study Results
The objective of this study was to assess the safety and efficacy of 1% and 5% MIM-D3 Ophthalmic Solutions compared to placebo for the treatment of the signs and symptoms of dry eye after a four week BID treatment period. The goal was to generate data to inform further Phase II/III trials, including the optimal dose, patient population and endpoints.
Goal of Dry Eye Therapy - Break the Cycle
Tear film instability leads to ocular surface damage, ocular irritation and discomfort, inflammation and sensory impairment. Patients experience episodic symptoms of discomfort and dryness, and impairment of the ocular surface to respond to environmental challenges, eventually leading to a chronic disease. In order to break this cycle, a product with a multifactorial mechanism of action is needed to better address this disease.
TrkA Receptor agonists are a novel pharmacological class for ocular disease. Nerve growth factor (NGF) is a dimeric polypeptide that belongs to the neurotrophin family and is critical for the survival and differentiation of neurons and many other non-neuronal cell types. NGF has multiple activities with potential benefit in dry eye disease including neurotrophic effects, corneal healing and mucin secretion. NGF signaling is mediated via two transmembrane receptors: the TrkA receptor and the p75NTR receptor. The ligand NGF, and its receptor TrkA are expressed throughout the lacrimal functional unit, suggesting they have a physiological role in the homeostasis and regeneration of the corneal stroma and epithelium.
Expression of TrkA in the Lacrimal Functional Unit
TrkA agonists have the potential to: stimulate mucin production (stabilize tear film and protect the ocular surface); stimulate corneal epithelial healing (by reducing ocular surface damage); and support the survival and differentiation of neurons (by improving corneal sensitivity, the functionality of the lacrimal unit and the ocular surface health).
MIM-D3 is a novel treatment for dry eye disease. MIM-D3 is a small, proteolytically stable cyclic peptidomimetic which is a selective TrkA receptor agonist. MIM-D3 demonstrates similar activities to NGF, such as promoting survival and differentiation of neuronal cells. MIM-D3 stimulates mucin secretion from conjunctival cells and improves corneal damage in a scopolamine induced experimental dry eye model in rats.
The trial was a multi-center, randomized, double-masked, placebo-controlled study comprised of a 1-week run-in period and a 28 day dosing period in 150 patients with a history of dry eye and objective evidence of ongoing dry eye disease. This study used a Controlled Adverse Environment chamber (CAE™) and with eligible subjects randomized in a 1:1:1 ratio into one of three treatment groups: MIM-D3 1%, MIM-D3 5%, or placebo.
The primary efficacy endpoints were corneal fluorescein staining post-CAE at day 28 and integrated diary worst symptom over the 28 day treatment period for 1% MIM-D3. A number of secondary endpoints, some of which could serve as approvable primary endpoints in future trials, were also looked at.
Key inclusion criteria for the trial included moderate corneal fluorescein staining; reduced tear film breakup and a moderate score on at least one symptom.
Efficacy Results: Signs
Total corneal staining score post-CAE for 1% MIM-D3 showed improvement relative to placebo, but statistical significance was not reached.
Significant improvement was observed with 1% MIM-D3 in inferior corneal fluorescein staining post-CAE compared to placebo at Day 28 in the ITT population (p=0.0322). Significant improvements were observed at the 1% dose in the ITT population in the change from pre-CAE to post-CAE in multiple regions at Day 28 (p<0.05)
Efficacy Results: Symptoms
Integrated Diary Worst Symptom for 1% MIM-D3 showed improvement relative to placebo, but statistical significance was not reached.
Significant improvement was observed with 5% MIM-D3 for Diary Dryness symptom over the 28 treatment period in the ITT population (p=0.0342).
Treatment-emergent adverse events (TEAEs) reported during the study were distributed fairly evenly among the treatment groups. The majority of the ocular TEAEs were mild to moderate in severity and there were no concerns raised by any of the ophthalmic examinations.
The study achieved significant improvements (p < 0.05) in key approvable sign and symptom endpoints.
On signs, significant improvements (p < 0.05) were observed at a 1% dose in the ITT population for fluorescein staining endpoints. The improvements were robust, and occurred in multiple analyses and multiple scoring regions.
On symptoms, significant improvements (p < 0.05) were observed at 5% dose in the ITT population for ocular dryness. An analysis of a more symptomatic patient subgroup showed that both 1% and 5% MIM-D3 significantly improved symptoms (p < 0.05) compared to placebo.
The drug MIM-D3 appeared safe and was well tolerated.
About Mimetogen Pharmaceuticals
Mimetogen Pharmaceuticals, Inc. is a private company focused on developing the use of peptidomimetics as a novel approach to treating diseases with high unmet medical needs. The underlying technology was developed at McGill University and the Lady Davis Institute for Medical Research in Montréal. The Company is currently developing novel therapeutic approaches for ophthalmic indications including dry eye disease, glaucoma and other degenerative diseases of the retina. Mimetogen also possesses a pipeline of lead compounds for non-ophthalmic indications (such as neurodegenerative disease and pain). Please visit the corporate website at www.mimetogen.com
About Medwell Capital Corp.
Medwell Capital Corp. is a Canadian-based investment and advisory firm. For further information please visit www.medwellcapital.com.
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