Since we are all kicking around how to best put together a media contact package I wanted to share something I wrote in case it can be helpful. Whether it's used, pulled from, or just utilized for inspiration, (or even ignored) please feel free to add this in any shape or form to whatever you put together.
Hi, I’m writing to you today with an idea for a story related to Covid and our country’s urgent need to find a therapeutic. It’s the story of an American biotechnology company that has, to this point, flown under the radar due to its small size. While small, Cytodyn and its monoclonal antibody are in a position to do very big things and are actually ahead of just about any other therapeutic company in the world.
Leronlimab, its lead product has been in testing for years as an HIV medication, proving itself not just effective but extremely safe. It’s mere months away from approval for HIV. Its impressive safety, as well as the amazing results in over 60 critical Covid patients who had failed products like Remdesivir and Hydroxychloroquine, is why the FDA only required 75 patients for their Phase 2 trial in mild to moderate Covid patients. That trial just concluded and topline extremely positive results were just released this week.
This is huge news because to date nobody has shown any efficacy in mild to moderate Covid-19 patients, let alone any real placebo-controlled efficacy in severe and critical. There’s also a large severe and critical trial ongoing with Leronlimab too, which will soon have an interim analysis. That trial is a Phase 2/3 based on the early and tremendous results in those 60+ emergency (EIND) patients across the country including at Montefiore in NY and UCLA. One patient even came off of life support in 3 days after trying Leronlimab as a last resort. She had been on life support for 30 days and had failed everything. But, I digress.
As you may know, a Phase 2 trial is usually used to determine safety as well as to help determine which of the many primary and secondary endpoints tested should become the focus of the final Phase 3 trials needed for approval. In some cases, like with Remdesivir, the FDA will take a successful endpoint in a Phase 2 or Phase 3 trial and give an emergency approval based on an unmet medical need or because of a pandemic like Covid-19 has caused.
In Cytodyn’s Phase 2 trial they were able to show symptom relief in 3 days, but more importantly they were able to lower the risk that patients would progress to more severe conditions. A global and objective standard called NEWS2 is used to determine if a patient would or could progress to something like a ventilator, and be more susceptible to becoming one of the hundreds of thousands who have died from Covid-19 complications. Leronlimab-treated patients in a double blind, placebo-controlled trial showed an improvement in the NEWS2 score by 150% compared to patients on the standard of care plus placebo.
This can be the story about how a small but feisty American company beats the entire world to a real therapeutic for Covid-19. How people can get back to work, our economy can recover, and how in the face of the largest governments and pharmaceutical companies in the world, it was an American company and American ingenuity that struck the first important blow against Covid-19.
Here are some helpful links that can significantly shorten your research time:
<insert links and short descriptions here>
<insert links and short descriptions here>
Hi, I’m writing to you today with an idea for a story related to Covid and our country’s urgent need to find a therapeutic. It’s the story of an American biotechnology company that has, to this point, flown under the radar due to its small size. While small, Cytodyn and its monoclonal antibody are in a position to do very big things and are actually ahead of just about any other therapeutic company in the world.
Leronlimab, its lead product has been in testing for years as an HIV medication, proving itself not just effective but extremely safe. It’s mere months away from approval for HIV. Its impressive safety, as well as the amazing results in over 60 critical Covid patients who had failed products like Remdesivir and Hydroxychloroquine, is why the FDA only required 75 patients for their Phase 2 trial in mild to moderate Covid patients. That trial just concluded and topline extremely positive results were just released this week.
This is huge news because to date nobody has shown any efficacy in mild to moderate Covid-19 patients, let alone any real placebo-controlled efficacy in severe and critical. There’s also a large severe and critical trial ongoing with Leronlimab too, which will soon have an interim analysis. That trial is a Phase 2/3 based on the early and tremendous results in those 60+ emergency (EIND) patients across the country including at Montefiore in NY and UCLA. One patient even came off of life support in 3 days after trying Leronlimab as a last resort. She had been on life support for 30 days and had failed everything. But, I digress.
As you may know, a Phase 2 trial is usually used to determine safety as well as to help determine which of the many primary and secondary endpoints tested should become the focus of the final Phase 3 trials needed for approval. In some cases, like with Remdesivir, the FDA will take a successful endpoint in a Phase 2 or Phase 3 trial and give an emergency approval based on an unmet medical need or because of a pandemic like Covid-19 has caused.
In Cytodyn’s Phase 2 trial they were able to show symptom relief in 3 days, but more importantly they were able to lower the risk that patients would progress to more severe conditions. A global and objective standard called NEWS2 is used to determine if a patient would or could progress to something like a ventilator, and be more susceptible to becoming one of the hundreds of thousands who have died from Covid-19 complications. Leronlimab-treated patients in a double blind, placebo-controlled trial showed an improvement in the NEWS2 score by 150% compared to patients on the standard of care plus placebo.
This can be the story about how a small but feisty American company beats the entire world to a real therapeutic for Covid-19. How people can get back to work, our economy can recover, and how in the face of the largest governments and pharmaceutical companies in the world, it was an American company and American ingenuity that struck the first important blow against Covid-19.
Here are some helpful links that can significantly shorten your research time:
<insert links and short descriptions here>
<insert links and short descriptions here>
7
