FDA Allows novel inhaled treatment BIO-11006 to commence human trials in adults with lung cancer.
MIAMI, April 21, 2017
MIAMI, April 21, 2017 /PRNewswire/ -- North Carolina based Biomarck Pharmaceuticals, Inc. has received FDA allowance l to begin human trials for their patented compound BIO-11006, for adults with lung cancer. Discovered by Dr. Ken Adler at North Carolina State University working in partnership with Biomarck, inhaled Bio-11006 has demonstrated effectiveness on human cell cultures and animals in the laboratory. It demonstrated impressive results in adult tumors and childhood cancers, specifically, Rhabdomyosarcoma, Neuroblastoma and Osteosarcoma in children. BIO-11006 has shown to be safe and tolerable in over 200 adult humans that have received the drug in previous studies for lung diseases.
Back in September, at the 3rd Annual Bella's Ball, the Live Like Bella® Childhood Cancer Foundation announced their partnership with Biomarck Pharmaceuticals and their plan to offer BIO-11006 for compassionate use starting the spring of 2017 for children battling certain types of cancer. It is amazing news that the FDA has allowed for human trails to begin and that Biomarck is moving forward to offer BIO-11006 for compassionate use. Dr. Guillermo De Angulo, Pediatric Oncologist in Miami, mentioned on stage during the ball, "There is nothing more difficult than having to look at parents in the eye and tell them, 'I'm sorry, there is nothing more we can do.' The promise of a potential new treatment option for compassionate use in children is very promising and very much needed." Now that the FDA has allowed human trials, new study sites will open around the country.
While not all cases will be eligible for compassionate use in children, Biomarck and Live Like Bella® intend to help as many children as they can with free drugs for cases that qualify and have not responded to approved treatment. Currently, BIO-11006 is administered via inhaled nebulizer and promises to be easy to take, particularly for children who normally receive cancer treatment intravenously.
Biomarck Pharmaceuticals, Inc. along with Live Like Bella® Childhood Cancer Foundation are excited and anxious to see the progress of BIO-11006 in adults and children with cancer and Acute Respiratory Distress Syndrome.
ABOUT LIVE LIKE BELLA® CHILDHOOD CANCER FOUNDATION
Live Like Bella® was founded in June 2013 in memory of Bella Rodriguez-Torres, who passed away at the tender age of 10 from Rhabdomyosarcoma, an aggressive childhood cancer. In her six-year battle she inspired millions to #LiveLikeBella and we are dedicated to finding a cure for pediatric cancer by funding innovative pediatric cancer research. Our Foundation also provides support for families with children currently in treatment and assists families who have lost a child to cancer with funeral or headstone expenses. For more information visit www.LiveLikeBella.org.
ABOUT BIOMARCK PHARMACEUTICALS, Inc.
Biomarck Pharmaceuticals, Inc. is a North Carolina biopharma company focused on developing products for serious diseases such as lung cancer and acute respiratory distress syndrome (ARDS). In conjunction with North Carolina State University and Live Like Bella® Foundation, Biomarck is delighted to support a compassionate use program in children with cancers who are not responding to approved therapy. For more information visit www.biomarck.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-allows-novel-inhaled-treatment-bio-11006-to-commence-human-trials-in-adults-with-lung-cancer-300443319.html
SOURCE Live Like Bella