Hi Cygnus7, real article, but you know yahoo, they won't let you post links. I'll try after I post this.
good question.... maybe late wakers from the west coast?
don't typos suck? Would love if yahoo would let authors edit their posts after posting
Celldex's Rindopepimut (Rintega(R)) Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-positive Glioblastoma
"The FDA's decision to grant Breakthrough Designation underscores rindopepimut's therapeutic potential for patients with glioblastoma," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "These patients have extremely limited treatment options, with only three new drugs approved in more than twenty years. Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients. With continued positive data, we look forward to working closely with the FDA to support potential approval of rindopepimut as expeditiously as possible."
Then the patient would probably die, but since the beads are safely inside the canister, with no way of escaping, your scenario is far fetched.
Based on its novel therapeutic mechanism and supporting clinical data, Time Magazine recently named our Hemopurifier® to the following lists: “The 25 Best Inventions of 2014” and “11 Remarkable Health Advances from 2014“.
In regards to our FDA approved clinical program, I am pleased to share that we have enrolled our first patient who has initiated a feasibility study protocol that is being conducted at the DaVita Medical Center in Houston, Texas. Under this feasibility study protocol, we will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier® therapy in an infectious disease model. Upon successful completion the study, we will seek FDA clearance to conduct pivotal efficacy studies required for market clearance to treat chronic viral indications. However, our current feasibility study also contributes safety data, which is the sole human challenge to advance Hemopurifier® therapy against category “A” threats whose virulence does not allow for human efficacy studies to be conducted. While this may be our first human clinical study in the United States, Hemopurifier® therapy has been previously administered with success overseas in Ebola, HIV and HCV-infected individuals. In closing, I hope you follow the clinical progression of our Hemopurifier® as a broad-spectrum countermeasure against virulent viral pathogens.
A convergence of global warming, environmental encroachment and the expansion of international transportation has contributed to an increased incidence of viral epidemics. In most cases, the viruses underlying these epidemics are not treatable with proven antiviral drug or vaccine countermeasures. In the absence of such therapeutic options, supportive care has remained the sole option to combat virulent pathogens, including category “A” viruses, which the National Institute of Allergy and Infectious Diseases (NIAID) categorize as posing the greatest risk to national security and public health. The viruses of greatest concern to NIAID include; Ebola, Marburg, Dengue, Smallpox, Junin, Machupo, Guanarito, Lassa, Hanta, Rift Valley, Crimean Congo, and Charpare and Lujo virus, which were new additions to the category “A” pathogen list in 2014. Beyond these threats are viruses genetically modified to be agents of bioterrorism, emerging drug resistant strains of HIV and Hepatitis C virus, and activated latent viruses that contribute to sepsis mortality and organ transplant rejection. To address the breadth of viral pathogens that threaten mankind, therapeutic innovation that reaches beyond traditional drug mechanisms will need to emerge.
Yesterday, we launched an FDA approved clinical study based on our vision for treating infectious viral pathogens. Instead of deploying a drug mechanism to inhibit the replication of a specific virus, we created the Aethlon Hemopurifier®, a medical device designed to capture viral pathogens through affinity attachment to a unique structure that enveloped viruses co-opt from host cells during replication. Based on extensive clinical research and collaborations, we believe our Hemopurifier® is the first broad-spectrum therapeutic candidate with demonstrated ability to capture different strains, species, and families of viruses.