Sahel Oncology is actively pursuing drug development in the field of oncology, with key products that have shown promising results in variety of cancer types. The main aim of Sahel is to apply therapies that improve overall survival , rather than tumor size or progression free survival. Sahel has dedicated last 8 years in experimental therapeutics and designed several clinical trials.
Background: In cancer the disease itself is so complicated that the efforts to make " one" drug to show any measurable efficacy usually fails. This makes the process of approval for a drug so difficult that in majority of the times, the goals for the therapy need to be modified to prove efficacy, for example a trial instead of looking at the overall survival ( OS) for the patients, only looks at the progression free survivals ( PFS) or time to progression and the bars set lower for the approval. Finally there is bias around the funding agency and the outcome. As you see below in an article published by British Medical Journal in 2003:
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
BMJ 2003; 326 doi: http://dx.doi.org/10.1136/bmj.326.7400.1167 (Published 29 May 2003)Cite this as: BMJ 2003;326:1167
What is different in Sahel: Sahel Oncology LLC has designed a combination protocol that is based on using compounds and methods that are targeting hundreds of genes and targets at the same time, bypassing the barrier on using " one drug for one target". The concept of pan-genomic effect is essentially vital in Sahel philosophy of drug development as it virtually can impact tumor heterogeneity.
Sahel has spent last 8-10 years studying the relevance of cutting edge science in oncology and stem cells into clinical applications. Hundreds of patients have been treated by such approach. many articles published, and of course the patents applied for and approved in US and beyond. Sahel has been fortunate to work with the most credible academic institutions in oncology and contracted experimental therapeutics for such purpose. Sahel has generated extensive amount of invitro and preclinical data along the way. Sahel foresees that in a proposed clinical trial, instead of a large sample size made of thousands of patients, as required by most of current trials, it can rely on large "effect size" to prove the concept. For a usual drug company these days as described, the effect size of the drug is so little, ( as there is one target for very drug), that there is a need to use thousands of cases in a trial to show efficacy. Here the number of patients in a clinical trial need only to be few, to show the same effect size. Currently Sahel is involved with several phase I/ II trials through the FDA.
Historically, in Sahel, the protocols, drugs and methods came all in place after treating patients who had failed all standard of care modalities. We were not creating targets in the labs and forming drugs based on that to SELL our product. Instead we were treating patients and reporting the success, and using the laboratory "to confirm" what we saw in the clinic. The process started with good medicine. All our finances were coming from patients who were treated successfully over the last ten years. All the research we did was based on the funds patients provided us. No venture capital or angels were involved and again we are proud that we relied on patient satisfaction to be alive and grow to a business model in Sahel Oncology LLC.