Is this treatment safe?
Any new procedure always carries risk, but the gene therapy delivery vehicle that LGT uses has been extensively used in clinical studies with no significant adverse events other than immune sensitivity. LGT pre-screens for immune sensitivity prior to inclusion in any of our studies. (See inclusion/exclusion criteria).
Why are we going outside the US?
65% of all clinical studies are now performed outside the US. It is quicker, cheaper, and an easier process with less overall regulatory risk.
What kind of physicians are providing care?
We have US physicians from one of the top hospitals in the country providing care, as well as affiliate physician staff in Colombia. We also have an advisory counsel of leading physicians.
Does Telomerase cause cancer?
It is unfortunate that this is controversial. In our view it should not be. We believe there is strong evidence to support that usage of telomerase does in no way cause cancer.
Does Libella have regulatory approval?
Many countries do not specifically regulate gene therapy. In such cases, an ethics committee approval is required. We work as closely as possible with Ministry of Health regulators to ensure we are providing care with their full knowledge, and where available, their approval.
Why isn't Big Pharma doing a clinical study like this?
They don’t have Dr. Bill Andrews. In the last 3 months, 2 gene therapies have received US regulatory approval. Big Pharma is moving quickly into the gene therapy world, but it would be difficult for them to provide this particular therapy without the in-depth knowledge and technology that Dr. Andrews has developed over the last 30 years.
Why is the cost so high?
The technology, lab capacity, scientific and medical professionals, and approvals, are extraordinarily costly. The gene therapy particles alone could not have been produced in enough quantity to offer this therapy until recently, but even given all the advances in the last couple years, the lab and technical costs are extreme.
How long before I will know if it worked?
We can’t say for sure, and it may not work at all. Based on animal and human tissue data that is available, we believe there is a better than average chance we (and you) will know within 3 months.
Why aren't other gene therapy companies offering this therapy?
Others are trying. The concept over delivering hTERT into cells is widely understood. However, the intricacies involved with actually making it work, are extremely difficult. Libella is the only company that is exclusively licensed with Scierra Sciences and Dr. Bill Andrews. If others had his technology, we would not be alone in offering this care.
How is the gene therapy administered?
LGT delivers the gene therapy particles via IV and intrathecal injection. The whole process takes 30 min to 1 hour, and is not painful. You will be followed closely for the next 2-3 days to insure the procedure went smoothly.