Good news is coming for patients suffering from Cystic Fibrosis. After highly successful Phase I trials of the AeroVanc inhaled version of vancomycin hydrochloride, the first patient has begun the Phase 2 testing by Texas pharmaceutical company Savara Pharmaceuticals.
The intent of these trials is to determine the ability of vancomycin hydrochloride in an inhaled form to fight infection by methicillin-resistant Staphylococcus aureus (MRSA) in those that suffer from cystic fibrosis (CF).
Lung infections from MRSA affects nearly one-third of those that have cystic fibrosis, and has been linked with overall decreased lung function, greater number and duration of hospitalizations, and significantly abbreviated life-expectancy. It has proven very difficult to treat under existing conditions due to the chronic nature of CF. Typical medical intervention involves the use of intravenous vancomycin hydrochloride, which traditionally can have poor penetration into the lungs and increase systemic toxicity, adding numerous side-effects while delivering limited results.
The AeroVanc Advantage
By using the AeroVanc inhaled treatment, the vancomycin can be delivered directly into the lung,s which maximizes its saturation levels at the areas where it is most needed while simultaneously preventing the drug from being circulated throughout the entire system thereby inhibiting side-effects in the already overtaxed bodies of CF patients.
AeroVanc is administered through a very simple capsule system that can be used by patients independently. It does not require complicated apparatus, injection, or intervention by a medical professional to be taken correctly.
The goal of Savara is that AeroVanc will do for those that contract MRSA what the TOBI inhaler did for the treatment of Pseudomonas aeruginosa in those with cystic fibrosis.
“We hope to provide similar benefits to MRSA infected patients that tobramycin provides for the treatment of Pseudomonas,” said Rob Neville, CEO of Savara Pharmaceuticals. “The response from the cystic fibrosis community has been very encouraging, so much so that physicians like to refer to AeroVanc as the ‘TOBI for MRSA’.”
“We are further encouraged by the strong interest and support of key opinion leaders, and the feedback that AeroVanc is exactly what the CF care community has been waiting for,” Neville added.
The Phase 2 Trial Process
Following standard clinical procedure, the Phase 2 trials will be double-blind and completely randomized. Patients will be given doses of 32mg or 64mg using the AeroVanc system, or will be treated with a placebo twice a day for 28 days.
The primary intent is to prove that AeroVanc reduces the colonization of methicillin-resistant Staphylococcus aureus.
The secondary intent is to see whether or not the treatment improves function of the lungs and respiratory system, limits symptoms in the patients, and reduces the need for additional antibiotic intercession.
Results are expected to be released early in 2014, at which time discussion with the FDA would focus on Phase 3 requirements.
The exact specifications of the Phase 2 AeroVanc trial can be found at the governments clinical trials website.
More on CF
Cystic fibrosis is a genetic illness wherein the lungs consistently produce extremely viscous mucus which creates an ideal breeding ground for lung infections such as MRSA and Pseudomonas aeruginosa. Median survival rate for those with CF is the mid-30’s.
The nature of the disease makes treatment of any infection difficult and physicians have been seeking new methods for eradicating bacterial infections that invade the pulmonary system. The FDA-approved TOBI Podhaler for Pseudomonas was the first dry powder inhaler approved for Pseudomonas. The hope is that AeroVanc will be equally – if not more – successful.
Savara has their headquarters in Austin, Texas. AeroVanc is their flagship product. They specialize in drugs that help those with chronic, serious, and life-threatening pulmonary illnesses. They receive funding from the National Heart, Lung and Blood Institute of the National Institutes of Health, and in March secured $11.5 million in funding from angel investors for their Phase II clinical trials of AeroVanc. More information can be found about the company by visiting the Savara Pharmaceuticals profile page on BioNews Texas, and on the Savara Pharmaceuticals website.
Read more about Cystic Fibrosis