Welcome to ALS Justice Now.org

Share  

Join us

 

PCUT.ORG on Facebook

> PCUT on Causes.Com

PCUT is a non-profit drug production company.

We fight for the lives of TODAY’s sufferers of rare terminal diseases, for whom there is neither a cure nor any effective treatment available.

A future cure is not the same as an effective treatment today.

Our focus on today’s sufferers is important, because providing people right now with every possible treatment that could extend their lives is a distinctly different goal than that of ultimately finding a cure for the disorder.  

We all share the interest in eradicating life threatening disorders for future generations.  But those patients who have been given a life expectancy of 2-5 years need something right now that slows the progression of their degenerative symptoms and gives them a chance to live long enough to benefit from future availability of better therapies.  It is an emergency situation.

Today’s discovery-phase research takes eight to twelve years to move through translational and clinical development before becoming available to the public.  Newly funded research rarely, if ever, can save the lives of ANY current sufferers of an imminently fatal disorder. When we focus solely on new research for an absolute cure, while neglecting existing, potentially effective treatment that could be put to use right now, we are throwing lives away.

We make therapies available by using the science that already exists.

PCUT sides with patients who are alive right now and who have chosen to fight for their survival.  We recognize that some in the health care and science communities discourage this view, but it is essential to stand up for the patients and their families who choose to do everything possible to beat their condition.

In the case of ALS (Lou Gehrig’s disease), a specific follow-on growth factor therapy has shown extraordinary promise in arresting motor-neuron degeneration, and in some cases reversing the progression of the disorder.  Additionally, the product has clearly demonstrated a clean safety profile, having been clinically tested in over 160 people, and anecdotally observed in over 80 ALS patients. This science already exists because in 2006 the therapy was FDA approved for a different disorder.  Unfortunately, due to economic conditions, the manufacturer was forced to abandon the program before it could be approved for ALS.

This is one example of an effective therapy that could be made available within months to dying patients who have no other effective treatment option, and who otherwise face near term death.  The patients cannot wait years for a cure.  But we can help them by using the science that already exists.

PCUT takes on therapy manufacturing programs that are not feasible in commercial markets.

What appears impossible for share-holder owned companies is often achievable with the addition of a non profit sponsor utilizing not-for-profit partnerships.  For each therapy it undertakes, PCUT forms a virtual production company with all components of production and clinical development.  We make the therapy available under our own non profit label and in partnership with original IP owners, consultants, contract manufacturers, clinics, and investigators.  

The Benefits


Desperately ill patients can finally access the promising therapies that could extend their lives when we produce enough to supply FDA-approved clinical trials and expanded access programs.

As PCUT shepherds each product through the clinical evaluation steps, FDA marketing approval becomes closer at hand.   Regulatory determination of product efficacy is a critical achievement in making a good therapy available to broad patient populations, worldwide.

PCUT’s royalty from the post-approval commercial proceeds allows it to re-use the business model on other therapies for other previously untreatable disorders.