For project 1, Dermetel’s clinical trial for the archaebacteria supplements opens on February 1st, 2019. We are finalizing paperwork with Indian authorities to run phase I of the clinical trial in India. Once we are in phase II and phase III, the trial(s) will be held in either Korea or Europe. Recruitment information will be listed on this page, so please check back frequently. We are hoping to recruit ten (10) participants for phase I. Though New Delhi is a long flight from the US, it is only a 6 hour flight from England. We will need around 1-2 months commitment from people for testing, and a longer electronic commitment for monitoring just to ensure we have the dosage right. We can provide letters for employers and/or disability authorities explaining the clinical trial situation if needed.
The trial will start on March 1st, 2019 and we have 3 participants committed thus far from the US, England, and Germany. Our main inclusion criteria is a formal diagnosis for type 1 from a board-certified medical geneticist doing a blood-based, whole exome gene sequencing exam. Over the years, we have found that the urinary tests are unreliable and thus exclusionary for the trial. Further, anyone with a formal diagnosis for type 2 is also excluded from the trial as the supplement is geared toward those with a genetic disability from birth, not those with a gut microflora imbalance from taking too many antibiotics. If you or your child meets these requirements, please write to us and we will send you further information in a packet. A referring physician letter is not necessary, only the genetic tests are needed as we have a team of physicians on board volunteering for the cause. All participants will receive a comprehensive thyroid examination at the start of the trial and will be tracked for variations in their progesterone and estrogen levels throughout the trial. The study design has received IRB approval via our external agency partner.
For project 2, Dermetel has found a venture capitalist who has generously agreed to fund the ERT surgical treatment. The trials for phases I to III will be held in either Korea or Europe via an agreement with the startup in question. An IPO will occur immediately after phase II and prior to the start of phase III, to raise awareness about the disease in popular culture as well as to ensure we are providing shareholder value and secure resources needed for future trials. Dermetel has a minority equity interest in the for-profit startup as we are running phases 1-3 of the clinical trial free of charge. The good news about this approach is that patients receive 100% free treatment for the entire duration of the trial—this is millions of dollars in savings because the treatment itself is very expensive. Further information will be announced in April.
In a stroke of amazing luck, a new hire with extensive pharmaceutical work experience will be taking the reins as the President of the organization. He has turned down much higher paying job opportunities to help us help others and we are very honored and lucky to have someone at his level and renown joining us. He will be managing the external partners and the internal volunteers to ensure tasks for projects 1 and 2 are run effectively, efficiently, and under budget. He begins January 14. There may be opportunities for the families of patients or people who care about democratizing dermatology to become staff members of Dermetel in the future thanks to our new incoming leader who has a fresh perspective and a bold vision. Thanks to him, we will soon have the opportunity to be much bigger than just a student group.
Our goal with both projects is to obtain approval in another country and then apply for FDA approval. Doing so saves about 2-5 years, getting both on the market sooner and more efficiently. Lysogene has set a good example for what motivated people in pharmaceuticals can do to inspire change and we feel confident following our new leader who has taken 18 drugs to market in his tenure at Pfizer.
Please do not hesitate to email email@example.com if you have any questions or would like to get involved. We are keen to bring in new medical and law student volunteers as many of us are graduating this year.
— Christine, Jon, Zivit, Ida, Shawn, and Misha