MANF Continues to Deliver Heading into 2H-14
Posted on Monday, June 30th, 2014 at 2:30 pm
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Looking back on the last two years, it is amazing to see how the MANF story has unfolded in conjunction with the other corporate initiatives the Company has undertaken including the addition of LymPro and Eltoprazine to our pipeline. The effort to diversify our pipeline was largely initiated to allow the Company’s scientific team to uncover MANF’s true value by identifying market opportunities with the highest net present value, which in biotechnology generally means fastest path to market in an orphan indication. That strategy bore fruit in the middle of 2013, when the Company identified in scientific literature a reference to MANF’s utility in Retinitis Pigmentosa (RP) from the University of Miami’s Bascom Palmer Eye Institute and later secured the intellectual property surrounding that finding. With an exclusive option agreement in hand, the Company has the necessary footing to make further investments in prosecuting MANF’s full potential in RP. Now midway through 2014, the Company is in the process of executing a methodical plan to deliver on the potential for MANF in RP, as well as continuing to expand with data the underlying scientific principles supporting MANF into new areas of research creating valuable intellectual property and know-how. Some of the key steps completed thus far include:
The Company has received interim data and is awaiting final results for functional assessments for MANF from a leading contract research lab with specialty in RP rodent models;
The Company has received interim data and is awaiting final results for toxicology safety assessments for MANF from a leading contract lab with specialty in rabbit ophthalmological models;
Researchers at the University of Miami have completed running additional experiments for MANF in functional models of RP, and expect their findings to be published in peer-reviewed journals in the near future;
The Company has received the final report from a leading contract research lab evaluating MANF’s activity in a tau hyperphosphorylation model of Alzheimer’s disease (AD). This study was conducted to confirm work previously published in a Chinese journal;
The Company has identified a number of significant independent peer-reviewed research papers published in Chinese journals confirming previously published Western data, as well as identifying new uses for MANF;
The Company has sourced contract manufacturing organizations capable of commercially manufacturing MANF, completed our due diligence and we expect to select a manufacturer in the third quarter.
All of the interim results we have seen to date in ophthalmology have been positive, which gives us a great deal of confidence heading into the second half of the year that RP will be the first of several INDs for MANF. All of the data being produced will be supportive of additional ophthalmological indications, including Wolfram’s-induced blindness which we are pursuing with Dr. Urano from the Washington University School of Medicine. Beyond these updates, the Company is establishing additional research collaborations with leading institutions in new and potentially groundbreaking areas, as well generating new IP surrounding the use of MANF in these various indications in the third quarter. We will be delivering the confirmatory AD results to the market very shortly, which in turn raises interesting prospects vis-a-vis our LymPro blood test for Alzheimer’s disease. When we first in-licensed LymPro, we had no idea that MANF could have an impact on aspects of the underlying pathophysiology of AD. However, with recently published data linking tau mis-folding to cell cycle dysregulation and amyloid aggregation, the prospect of MANF becoming the basis for new treatments in AD has become extremely interesting. Reproducibility is the hallmark of good science, and to date MANF has reproducibly demonstrated activity consistent with a breakthrough treatment across a highly valuable spectrum of indications. In addition, we are nearing the completion of the sourcing process necessary to retain our regulatory consulting group with expertise with a specialty in the area of ophthalmology to assist us in the filing of orphan drug designation with the FDA and EMA for MANF in RP. Based on the timelines and estimates we have received, we expect to submit to the FDA and receive a reply regarding our submission in the second half of this year, within the same time frame that we will be looking to up-list our common stock to a national exchange.
Last week we attended a successful BIO convention where we ended up participating in over 60 partnering meetings, and were extremely pleased with the reception we received from the community at large. It is clear that we have become highly visible to larger pharmaceutical companies, as well as promising early-stage companies seeking to partner their assets. The general theme was that each of our assets has tremendous promise within their own right, and most importantly that there is a strong scientific and business case to be made for each becoming a blockbuster asset. Taken together, the synergies created from a business perspective are able to insulate the Company from significant enterprise risk, and our ability to demonstrate progress with any of these assets will lend credibility to the rest of the portfolio. In light of these comments, we are now especially looking forward to the month of July which includes AAIC and our #C4CT Summit, as well as the rest of 2014. We believe the Company is growing stronger by the day and we are excited to share our enthusiasm with our fellow shareholders.
I thank you for taking the time to read this blog and look forward to updating you on additional progress for the Company as we achieve our true potential.
Warmest Regards,
Gerald E. Commissiong
President & CEO
- See more at: http://www.thechairmansblog.com/amarantus-bio...mfQqj.dpuf
Posted on Monday, June 30th, 2014 at 2:30 pm
0 0 0 Google +0
Looking back on the last two years, it is amazing to see how the MANF story has unfolded in conjunction with the other corporate initiatives the Company has undertaken including the addition of LymPro and Eltoprazine to our pipeline. The effort to diversify our pipeline was largely initiated to allow the Company’s scientific team to uncover MANF’s true value by identifying market opportunities with the highest net present value, which in biotechnology generally means fastest path to market in an orphan indication. That strategy bore fruit in the middle of 2013, when the Company identified in scientific literature a reference to MANF’s utility in Retinitis Pigmentosa (RP) from the University of Miami’s Bascom Palmer Eye Institute and later secured the intellectual property surrounding that finding. With an exclusive option agreement in hand, the Company has the necessary footing to make further investments in prosecuting MANF’s full potential in RP. Now midway through 2014, the Company is in the process of executing a methodical plan to deliver on the potential for MANF in RP, as well as continuing to expand with data the underlying scientific principles supporting MANF into new areas of research creating valuable intellectual property and know-how. Some of the key steps completed thus far include:
The Company has received interim data and is awaiting final results for functional assessments for MANF from a leading contract research lab with specialty in RP rodent models;
The Company has received interim data and is awaiting final results for toxicology safety assessments for MANF from a leading contract lab with specialty in rabbit ophthalmological models;
Researchers at the University of Miami have completed running additional experiments for MANF in functional models of RP, and expect their findings to be published in peer-reviewed journals in the near future;
The Company has received the final report from a leading contract research lab evaluating MANF’s activity in a tau hyperphosphorylation model of Alzheimer’s disease (AD). This study was conducted to confirm work previously published in a Chinese journal;
The Company has identified a number of significant independent peer-reviewed research papers published in Chinese journals confirming previously published Western data, as well as identifying new uses for MANF;
The Company has sourced contract manufacturing organizations capable of commercially manufacturing MANF, completed our due diligence and we expect to select a manufacturer in the third quarter.
All of the interim results we have seen to date in ophthalmology have been positive, which gives us a great deal of confidence heading into the second half of the year that RP will be the first of several INDs for MANF. All of the data being produced will be supportive of additional ophthalmological indications, including Wolfram’s-induced blindness which we are pursuing with Dr. Urano from the Washington University School of Medicine. Beyond these updates, the Company is establishing additional research collaborations with leading institutions in new and potentially groundbreaking areas, as well generating new IP surrounding the use of MANF in these various indications in the third quarter. We will be delivering the confirmatory AD results to the market very shortly, which in turn raises interesting prospects vis-a-vis our LymPro blood test for Alzheimer’s disease. When we first in-licensed LymPro, we had no idea that MANF could have an impact on aspects of the underlying pathophysiology of AD. However, with recently published data linking tau mis-folding to cell cycle dysregulation and amyloid aggregation, the prospect of MANF becoming the basis for new treatments in AD has become extremely interesting. Reproducibility is the hallmark of good science, and to date MANF has reproducibly demonstrated activity consistent with a breakthrough treatment across a highly valuable spectrum of indications. In addition, we are nearing the completion of the sourcing process necessary to retain our regulatory consulting group with expertise with a specialty in the area of ophthalmology to assist us in the filing of orphan drug designation with the FDA and EMA for MANF in RP. Based on the timelines and estimates we have received, we expect to submit to the FDA and receive a reply regarding our submission in the second half of this year, within the same time frame that we will be looking to up-list our common stock to a national exchange.
Last week we attended a successful BIO convention where we ended up participating in over 60 partnering meetings, and were extremely pleased with the reception we received from the community at large. It is clear that we have become highly visible to larger pharmaceutical companies, as well as promising early-stage companies seeking to partner their assets. The general theme was that each of our assets has tremendous promise within their own right, and most importantly that there is a strong scientific and business case to be made for each becoming a blockbuster asset. Taken together, the synergies created from a business perspective are able to insulate the Company from significant enterprise risk, and our ability to demonstrate progress with any of these assets will lend credibility to the rest of the portfolio. In light of these comments, we are now especially looking forward to the month of July which includes AAIC and our #C4CT Summit, as well as the rest of 2014. We believe the Company is growing stronger by the day and we are excited to share our enthusiasm with our fellow shareholders.
I thank you for taking the time to read this blog and look forward to updating you on additional progress for the Company as we achieve our true potential.
Warmest Regards,
Gerald E. Commissiong
President & CEO
- See more at: http://www.thechairmansblog.com/amarantus-bio...mfQqj.dpuf
