The plus side of cutting edge (or should that be patching/CRISPRing/ointment edge) medical treatment technology?
First micro-needle patches that feel like Velcro and have very few transportation and storage issues:
“An Atlanta-based biotech company last week said it successfully concluded the first-ever clinical trial testing of a microarray injection-free vaccine on children as young as 9 months old. Micron Biomedical tested microneedle-based delivery of the measles-rubella (MR) vaccine on children in Gambia with backing from the Bill & Melinda Gates Foundation and the Centers for Disease Control and Prevention (CDC).”
“Forty-five adults, 120 toddlers (15-18 months old) and 120 infants (9-10 months old) were enrolled in the clinical trial and randomized to receive the MR vaccine either via Micron’s microarray or through subcutaneous injection, meaning beneath the skin.”
“The study reported similar seroprotection rates of approximately 90% or more after 42 days for the groups that received the microarray and subcutaneous injections.” Just press releases of results so far, nothing published.
I wonder whatever happened to “mumps”? No surprises that the BMGF supports human experimentation on children in Africa – looks like standard operating procedure as revealed in RFK jr.’s book “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health”. The CDC? Well, not that distant from Fauci’s old haunt, NIAID and it is active in monitoring diseases south of the US border. Micron Biomedical probably does not develop the contents of the patches, just the “patch” delivery mechanism?
Lots of money involved.
“The Gates Foundation, the CDC, Unicef, PATH — another heavily Gates-funded organization — and the Georgia Research Alliance provided Micron with $40 million in funding to develop its microneedle patch technology.”
I wonder how much money the CDC handed over and how much competition for the money was involved – probably not much other than, maybe, an Australian company, Vazzas.
“n 2017, the Gates Foundation gave Micron a $2.2 million grant to develop the microneedle patch for the MR vaccine and another $900 million in 2022. Gates had previously awarded Micron $2.5 million to develop a microneedle patch for polio as part of the foundation’s effort to eradicate polio.”
Nine hundred million from the BMGF in 2022, wow! Money moving at the speed of science!
Series A of around 17 million bucks include venture capital funders Global Health Investment Corporation, LTS Lohman and J2 Ventures,
Moving onto CRISPR developments, we have this from here a few months ago:
Forget designer babies. Here’s how CRISPR is really changing lives | MIT Technology Review
“The gene-editing tool is being tested in people, and the first treatment could be approved this year.”
“.. there are now more than 50 experimental studies underway that use gene editing in human volunteers to treat everything from cancer to HIV and blood diseases, according to a tally shared with MIT Technology Review by David Liu, a gene-editing specialist at Harvard University. “
Most of these studies—about 40 of them—involve CRISPR, the most versatile of the gene-editing methods, which was developed only 10 years ago."
“Vertex Pharmaceuticals, says it’s treated more than 75 people in its studies of sickle cell, and a related disease, beta-thalassemia, and that the therapy could be approved for sale in the US within a year. It is widely expected to be the first treatment using CRISPR to go on sale.” It requires a bone marrow transplant as part fo the protocol and has a market size of around 32,000 in the EU + US.
“Along with Vertex, a wave of biotech companies, like Intellia, Beam Therapeutics, and Editas Medicine, are hoping they can use this technology to develop successful treatments.”
75 people in Gambia. I guess that’s equivalent to half a dozen American lab rats used for trials of the BA4/BA5 bivalent mRNA injection?
And lastly, ointments.
From here on 19 May 2023:
Publicized by the company, Krystal Biotech, here:
With a h/t to Expose-news.com here:
FDA approves first gene therapy ointment – The Expose (expose-news.com)
From the FDA:
“Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.”
From the company.
· Dystrophic Epidermolysis Bullosa (DEB) is a serious rare genetic disease that affects the skin and mucosal tissues and is caused by one or more mutations in the COL7A1 gene, resulting in lack of production of functional type VII collagen (COL7) protein
· VYJUVEK is a topical gel that addresses the genetic cause of DEB by restoring functional copies of the COL7A1 gene to patients and is the only medicine available for patients in the US
· VYJUVEK is approved for the treatment of patients six months of age or older with either recessive or dominant DEB
· VYJUVEK is approved to be administered by a healthcare professional either in a healthcare professional setting (e.g., clinic) or a home setting
· Data from the pivotal Phase 3 (GEM-3) trial, published in the New England Journal of Medicine, demonstrated that the trial met its primary endpoint of complete wound healing at six months and its key secondary endpoint of complete wound healing at three months
And from Expose-news.com
“Since 2017, the FDA has approved five gene therapies for rare inherited diseases – Krystal’s will make it six – and several others for treating blood cancer. But those earlier treatments are all delivered by injection or by altering immune cells outside the body. By formulating gene therapy into an ointment that’s rubbed on, Krystal has achieved what its CEO, Krish Krishnan, has called “a simple, convenient, patient-friendly way to provide the missing gene to these patients.”
Onwards!
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