Theralytix was founded by entrepreneur and real estate investment speaker Matthew McClellan. Matthew was watching in horror as his friend's daughter, who has cystic fibrosis, was dying from a lung infection called Pseudomonas aeruginosa. People with cystic fibrosis tend to have weakened immune systems and are therefore highly susceptible to opportunistic Pseudomonas aeruginosa or its close relative, Burkholderia cepacia. These species are highly destructive to cell tissue and can cause rapid loss of lung capacity in these patients. Antibiotics begin to fail once biofilms take hold in the lungs; children can succumb to the infections at a very young age.
While frantically searching for a treatment for Mary, through Mary's mother, Matthew came across information about phage therapy. Shocked that this was not available for the U.S. market as well as the global need for this type of therapy, it was worth a try. Matthew contacted one of the Eastern European clinics and, after testing for sensitivity, acquired some of the product. There was a dramatic result: within hours after using phages Mary's face returned to its normal color and she began to breathe normally. Within a couple of weeks, the infection was gone.
Accessing the product was, however, quite difficult. Produced in Eastern Europe under questionable conditions, it was necessary to follow bureaucratic protocol that took several weeks. Since that time, FDA has banned compassionate use import of these products from the producing countries, citing non-standard manufacturing methods and medical claims that the products “cure” diseases — where there is no proof of such claims.
“These products need to be readily available to people in the US and elsewhere, not just in Eastern Europe”. Matthew contacted the CEO of the company that provided the phage preparations, to determine how he could make these products in the US. Smith, who has been working with this technology for almost 20 years, helped Matthew connect with many of the top scientists in the field. And so product development has begun -- with phages against Pseudomonas aeruginosa being a top priority for the company.
Undergraduate biology students can usually find bacteriophages in the environment, primarily in rivers. A number of groups are creating massive collections of these phages that are acquired from a multitude of sources. Assuming the phages are "safe" and lytic, and bearing in mind the fact that there are many thousands of strains of pathogenic bacteria with varying sensitivities to both bacteriophages and antibiotics, there is always a possibility that one or more of the phages in such collections could be utilized to treat a given patient. It is nearly always the rule that such sourced phage isolates are narrow spectrum by their nature and thus it is necessary to create a custom product for each patient. This is a niche that is likely to grow, however it is not scalable as it is a laborious and expensive activity. In the end, the costs associated with maintaining massive collections of phages with questionable therapeutic value may be less then ideal since it is not difficult to find a lytic phage for a specific strain of bacteria. This model would be impractical when attempting to address regional outbreaks of infection such as dysentery, which alone takes the lives of millions every year.
The process of isolating and assembling between one and three select broad spectrum bacteriophages (per targeted genus) into cocktails with relatively wide therapeutic value is a completely different exercise; this requires significant skill and experience. Our team members, having developed some of the world's most effective phage cocktails, excel in this discipline. Phage cocktail development is but one element of the value chain. Manufacturing techniques, such as replication and proper therapeutic titer production for each genus, clinical laboratory and treatment protocols are integral to successful patient outcomes -- all techniques that are well understood by our leadership and development team members.
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