Medical lasers are typically large, complex, expensive machines designed to selectively damage or destroy tissue. A second approach involves the use of low-power lasers to modulate cellular metabolism as a means of relieving chronic pain or promoting wound healing (low level laser therapy, LLLT, or “cold” laser therapy). In contrast to these two approaches, Bosto
n BioCom is developing a new treatment paradigm based on the use of small, portable laser devices that can rapidly induce non-destructive tissue stress for therapeutic purposes. The targets for this approach are “boundary tissues,” which form a barrier to the external environment or line the body’s internal cavities. Barrier tissues include the skin, the entire gastrointestinal tract from mouth to rectum, the lining of the respiratory tract from nose to lung, and the lining of organs such as the bladder.
Boundary tissues have evolved specific cell populations and inter-relationships designed to protect and preserve the boundary between the external environment and internal organs. These tissues have an enhanced ability to cope with stresses emanating from the other side of the boundary (e.g., heat, dehydration, radiation, toxins, pathogens), and most have specialized immune cell populations that improve surveillance of and response to invasion by pathogens coming from the exterior. Some of the self-defense pathways in these tissues can be rapidly triggered by acute, low level stress and produce long-term tissue protective effects. We are using lasers to create short-term, non-damaging stress in these tissues in order to trigger protective responses that can be used in treating disease and enhancing defense against disease.
This technology approach is based on the work of Russian scientists, who performed the initial proof of concept studies in vitro, with animal models, and in several pilot studies in humans. Many of the initial findings of these investigators have now been replicated by researchers at the Massachusetts General Hospital and Harvard Medical School.
We are currently building on the proprietary insights of these scientists and are now commercially developing a laser platform to apply this principle to a number of important medical areas, including infectious diseases, oncology, and immunology. We have licensed relevant patent applications related to this approach, filed additional patent applications, and are in the process of developing prototypes for further testing. The company has initiated a number of research partnerships with government and non-profit research entities further explore and develop the technology for medical applications.
We are currently developing two different applications based on the principles of non-destructive laser tissue stress. The first is a method of improving focal hyperthermia as a medical treatment for diseases that affect barrier tissues. The second method is a way of enhancing immune responses to vaccinations.
Enhanced Laser Hyperthermia
The use of hyperthermia to treat diseases is a long-established practice in medicine and is currently applied as an adjunct treatment for several types of cancer. Standard focal hyperthermia treatment is designed to induce programmed cell death (apoptosis) at lower temperatures or uncontrolled cell death (necrosis) at higher temperatures. Systemic hyperthermia is used to enhance the effects of chemotherapy or radiation. Established approaches to focal hyperthermia typically use a variety of radiofrequency devices for
treatments lasting 20-40 minutes, but lasers have also been used in a limited fashion to perform interstitial hyperthermia treatment in tumors more quickly. In addition, a number of experiments have been conducted over the last two decades in using lasers to rapidly treat cutaneous diseases such as basal cell carcinoma and viral warts. These trials have been relatively successful but required the use of fairly high irradiances (power densities) that resulted in pain from treatment and caused a variety of side effects in patients including infections and scarring.
Boston BioCom is modifying the parameters of treatment with lasers in a way that allows effective treatment to be provided at far lower irradiances and lower treatment temperatures. This means that effective treatment can be given without causing pain, wounding or scarring. We believe this novel approach has utility in treating lesions such as actinic keratosis or skin and genital warts, where conventional treatment approaches such as cryotherapy involve pain, wounding and wound healing, and can potentially leave scars. These approaches could then be extended to the treatment of other focal lesions in other organs.
Enhanced Vaccine Response
Specific parameters of laser light also appear to enhance the ability of barrier tissues like the skin to promote an immune response to vaccines. This approach has promise to improve immune responses to both existing and new vaccines without requiring the reformulation of these vaccines. The skin has always been viewed as an important immune target for vaccination, but intradermal vaccination often fall short of sufficient efficacy in humans. The use of small lasers to prime the skin before vaccination has promise to change this picture, and can make needle-free vaccination approaches more successful. In addition, laser treatment has potential to improve the vaccine response of populations that normally do not benefit as much from vaccinations such as the elderly, infants and immunosuppressed populations like transplant patients and people on dialysis.
Conventional approaches to improving immune responses rely on chemical or biological adjuvants. While a wide range of adjuvants are
under investigation, to date very little progress has been made in the United States in finding widely applicable adjuvants that provide both significant immunostimulation and low side-effect profiles. Since the approval of aluminum compounds in the 1930s, The U.S. Food and Drug Administration has only approved one new vaccine adjuvant for clinical use, the combination of aluminum hydroxide and monophosphoryl lipid A used in the Cervarix HPV vaccine (GlaxoSmithKline, London, UK), which was approved in 2009. The use of a laser to prime the skin for immunization is a novel approach that can make most vaccines work better without the need for chemical or biological adjuvants.
We are currently testing a variety of laser systems in collaboration with the Ragon Institute of Infectious Diseases and the Wellman Center for Photomedicine at Massachusetts General Hospital to identify the best combination of parameters to use to enhance vaccine response. In addition, we are preparing to begin the first human study in the West on laser enhancement of vaccination. We will be conducting a clinical study to demonstrate enhanced effect of influenza vaccination when combined with a short non-damaging skin laser pre-treatment. The clinical trial is part of a research project funded by the United States Space and Naval Warfare Systems Center Pacific and managed by the Defense Advanced Research Projects Agency (DARPA).
We are also exploring applications of the laser system to therapeutic vaccines. A number of therapeutic vaccines have failed in mid- and late-stage clinical testing due to a lack of efficacy. Combining these vaccines with laser pre-treatment may give them sufficient immune response to receive approval for use in humans.
