Mimetogen Phase II Data For MIM-D3 Presented at Leading Ophthamology Conference

    




 EDMONTON, May 7, 2012 /CNW/ - Medwell Capital Corp.  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 (p0.05 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 

 Objective 

 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. 

 Trial Design  

 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 (p0.05) 

 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). 

 Safety Results 

 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. 

 Conclusions 

 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. 

 Neither TSX Venture Exchange nor its Regulation Services Provider (as  that term is defined in the policies of the TSX Venture Exchange)  accepts responsibility for the adequacy or accuracy of this release.   This press release may contain forward-looking statements, which  reflect the Company's current expectation regarding future events.  These forward-looking  statements involve risks and uncertainties that may cause actual  results, events or developments to be materially different from any  future results, events or developments expressed or implied by such  forward-looking statements.  Such factors include, but are not limited  to, changing market conditions, the successful and timely completion of  clinical studies, the establishment of corporate alliances, the impact  of competitive products and pricing, new product development,  uncertainties related to the regulatory approval process and other  risks detailed from time to time in the Corporation's ongoing quarterly and annual reporting.  We undertake no obligation to  publicly update or revise any forward-looking statements, whether as a  result of new information, future events or otherwise. 

Medwell Capital Corp.


CONTACT:  Tony HesbyMedwell Capital Corp.780-413-7152780-408-3040 FaxE-mail: [e-mail]: http://www.medwellcapital.comRoss MarshallInvestor Relations416-815-0700 ext. 238416-815-0080 FaxE-mail:[e-mail] 


    

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