Over half a million Americans continue to struggle for years on end with the pervasive complications of late stage Lyme disease. The disease, which is generally straightforward to treat if caught early, has the potential to become a debilitating long-term illness with symptoms including arthritis, central nervous problems, memory and muscle control issues, and even serious heart conditions. Meanwhile wide variations in symptoms and disease progression and debate about long-term antibiotic use complicate treatment options.

At Bay Area Lyme Foundation, we are excited to support a promising new therapy being developed by Stanford University’s BioMaterials and Advanced Drug Delivery (BioADD) Laboratory, now ready for clinical trial. See our blog post for more information about this discovery.

Update as of January 2017

Three years ago, Bay Area Lyme Foundation funded breakthrough research with Stanford University’s BioMaterials and Advanced Drug Delivery (BioADD) laboratory that held potential promise for many suffering from Lyme disease. Studying the impact of loratadine (brand name Claritin®) on Lyme patients remains a high priority for the Bay Area Lyme Foundation. Much has changed in the field of since the initial research at Stanford was completed, resulting in our review of the original protocol developed for the clinical trial.

We recognize that there is disagreement amongst experts on the best treatment for late Lyme disease symptoms and some research efforts are criticized and results questioned.  Although this is a recognized part of the clinical research process our goal is to learn from previous efforts and develop and execute a robust, well-designed protocol that will withstand scientific scrutiny and be published in a leading medical journal.  Should we have a positive response our study subjects will have the dual reward of their own improvement and the knowledge that their efforts have contributed towards the advancement of clinical knowledge to help others.  This spring we plan to bring thought leading physicians and scientists together to come to consensus on the optimal study design.

Our trial will be as broadly inclusive as we can make it. We will keep your information on file and hope to have news of future progress in this area to you soon.

How Does the Treatment Work?

This combination therapy leverages an antibiotic in conjunction with the “re-purposing” of an over-the-counter FDA-approved compound.  In addition to its approved indication, our research has shown that it has other useful actions:

1. It blocks Manganese (Mn) from entering the Lyme spirochete and slows its life-sustaining protein synthesis

2. It protect the human immune system from antibiotic toxicity by preserving macrophages responsible for removing cellular debris

3. It maximizes the effect of the antibiotic in targeting the harmful bacteria

borrelia-Helf-intracel_Overlay_01_z04_572Image: Three color conofocal image of Borrelia spirochete (green), cell nucleus (blue), and structural proteins (red) inside an infected Human Embryonic Lung Fibroblast (HELF) cell.

The Clinical Trial

It is exciting to have a promising solution demonstrating such a substantial effect in lab. A successful clinical trial and subsequent publication of results in a leading peer reviewed journal will get the message out and enable this treatment to be adopted by physicians. The Clinical Trial is planned to start in late summer (during the northeast tick season) through late fall (on the west coast).

Thanks to many generous Bay Area Lyme supporters, we have already raised more than $850,000 toward the cost of the clinical trial. Thanks to your support we are making this treatment a reality.

Please join us. To make your contribution and bring relief to those suffering from this painful illness, please donate today.

Patient Recruitment

Sample criteria for the clinical trial are still being developed but will include:

  • 200 patients, ages 18 and older
  • All regions of the country
  • Evidence of prior acute and late stage Lyme disease
  • Ability to participate in the full course of the treatment and study

 

Image courtesy of Dr. Ravi Pothineni