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Posted On: 09/09/2020 8:43:05 AM
Post# of 72
An email Chris sent me a while back. I thought some of our newer posters might enjoy. Will post others as I have time.
Christopher Reinhard (CReinhard@Angionetics.com)
To:you + 1 more Details
Hi xxxxxxx
Many thanks for your email. I hope that you and your family are likewise staying safe and healthy. Our business plan remains unchanged from my previous emails. With new access to capital, additional skilled resources and infrastructure support, as a result of our recently completed transaction with Nostrum, we are in the process of bringing our SEC filings up to date, up- listing of our stock, the manufacturing of the Ad5FGF-4 product candidate for planned clinical study, and preparing to start our FDA-cleared Phase 3 clinical study. As you may know, me and a small team here in San Diego over the past 20 years have advanced Ad5FGF-4 from a bench lab at the University of California San Diego, and now into Phase 3 clinical studies, and we look forward to completing the planned Phase 3 clinical study intended to commercially market and sell Ad5FGF-4, first in the U.S., and then worldwide.
I have sent along a few slides to provide a bit more insight into our efforts, and to discuss the many challenges covering developing ‘anti-anginal’ therapies. In the last fifty years, the FDA has approved only one anti-anginal drug with a new mechanism of action -- Ranexa (ranolazine). The FDA approval of anti-anginal medications have few and far between. As outlined in the first chart above, the clinical development for Ranexa began was initiated by Snytex Corp. in 1985, and then it was sold to Roche and years later it was acquired by CV Therapeutics. Over 21 year development, after multiple clinical failures and economic setbacks and challenges, Ranexa was finally approved by the FDA in 2006. a 21 years of development. Following FDA approval, a few years later, CV was acquired by Gilead Sciences for $1.4 billion.
In the second chart, we have developed a proposed treatment algorithm following FDA approval, as a new anti- anginal with a mechanism of action, as a angiogenic gene therapy. Generx is single administration , angiogenic gene therapy which is administered during a basic diagnostic angiogram procedure by a interventional cardiologist for a patients with refractory angina. To be eligible for the Ad5FGF-4, a patient will have failed anti-angina drug therapy, and not be eligible for mechanical revascularization (bypass surgery or stent). As this chart further details, we estimate there is an estimate that are approximately 1.2 million patients in the US with refractory angina. It is an significant unmet, medial need, which was the basis for the Generx product candidate being designated with FDA Fast Track status. It is our focus is to offer patients with chronic myocardial ischemia with a new therapeutic clsdd whice we are poneering called “medical revascularization” ( our angogenic therapy) , in addition only two current treatment options: (1) maximal anti-anginal drugs and (2) mechanical revascularization.
The third chart above, provides our commentary about the Generx clinical development I hope that this summary slide conveys the high level enthusiasm that we have for Generx, our continuing excitement for potential clinical and commercial success , and the potential significant economic opportunity we see ahead.
In closing, many thanks for your investment and your continued interest.
Regards,
Chris
Christopher J. Reinhard, Chairman & Chief Executive Officer | Angionetics/Cardium |
mobile (858) 414-1477 | e-mail creinhard@angionetics.com
Christopher Reinhard (CReinhard@Angionetics.com)
To:you + 1 more Details
Hi xxxxxxx
Many thanks for your email. I hope that you and your family are likewise staying safe and healthy. Our business plan remains unchanged from my previous emails. With new access to capital, additional skilled resources and infrastructure support, as a result of our recently completed transaction with Nostrum, we are in the process of bringing our SEC filings up to date, up- listing of our stock, the manufacturing of the Ad5FGF-4 product candidate for planned clinical study, and preparing to start our FDA-cleared Phase 3 clinical study. As you may know, me and a small team here in San Diego over the past 20 years have advanced Ad5FGF-4 from a bench lab at the University of California San Diego, and now into Phase 3 clinical studies, and we look forward to completing the planned Phase 3 clinical study intended to commercially market and sell Ad5FGF-4, first in the U.S., and then worldwide.
I have sent along a few slides to provide a bit more insight into our efforts, and to discuss the many challenges covering developing ‘anti-anginal’ therapies. In the last fifty years, the FDA has approved only one anti-anginal drug with a new mechanism of action -- Ranexa (ranolazine). The FDA approval of anti-anginal medications have few and far between. As outlined in the first chart above, the clinical development for Ranexa began was initiated by Snytex Corp. in 1985, and then it was sold to Roche and years later it was acquired by CV Therapeutics. Over 21 year development, after multiple clinical failures and economic setbacks and challenges, Ranexa was finally approved by the FDA in 2006. a 21 years of development. Following FDA approval, a few years later, CV was acquired by Gilead Sciences for $1.4 billion.
In the second chart, we have developed a proposed treatment algorithm following FDA approval, as a new anti- anginal with a mechanism of action, as a angiogenic gene therapy. Generx is single administration , angiogenic gene therapy which is administered during a basic diagnostic angiogram procedure by a interventional cardiologist for a patients with refractory angina. To be eligible for the Ad5FGF-4, a patient will have failed anti-angina drug therapy, and not be eligible for mechanical revascularization (bypass surgery or stent). As this chart further details, we estimate there is an estimate that are approximately 1.2 million patients in the US with refractory angina. It is an significant unmet, medial need, which was the basis for the Generx product candidate being designated with FDA Fast Track status. It is our focus is to offer patients with chronic myocardial ischemia with a new therapeutic clsdd whice we are poneering called “medical revascularization” ( our angogenic therapy) , in addition only two current treatment options: (1) maximal anti-anginal drugs and (2) mechanical revascularization.
The third chart above, provides our commentary about the Generx clinical development I hope that this summary slide conveys the high level enthusiasm that we have for Generx, our continuing excitement for potential clinical and commercial success , and the potential significant economic opportunity we see ahead.
In closing, many thanks for your investment and your continued interest.
Regards,
Chris
Christopher J. Reinhard, Chairman & Chief Executive Officer | Angionetics/Cardium |
mobile (858) 414-1477 | e-mail creinhard@angionetics.com
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