WHAT IS COMPASSIONATE USE?

Medical professionals use the term “compassionate use” to refer to the treatment of a patient using a new, unapproved drug when no other treatments are available. Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs. These drugs are generally available only to people who are taking part in a clinical trial. Being able to use one of these drugs when you are not in a clinical trial is most commonly referred to as compassionate use (American Cancer Society®).

“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,’" said Dr. Guillermo De Angulo, Pediatric Oncologist in Miami. "The promise of a potential new treatment option for compassionate use in children is very promising and very much needed.”

OUR GOAL

In September 2016, 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.

IMPORTANT GUIDANCE ON REQUESTING EXPANDED ACCESS/COMPASSIONATE USE OF BIO-11006

Please note that BIO-11006 is NOT available currently for clinical trials in childhood cancers. FDA has given allowance for Biomarck to begin human trials only in adult lung cancer patients. What can be considered is only compassionate use of the product which must be approved by FDA for each individual case. It is not yet known what effect this product has on cancer. Some important guidelines to qualify are as follows:

1. Does the patient live in the US?
2. Does the patient have rhabdomyosarcoma (RMS), Neuroblastoma (NB), Sarcoma or Glioma?
3. Has the patient failed to respond to all current FDA approved treatment?
4. Is the patient under the care of an Oncologist (Cancer Doctor)?

If the answers to ALL of these is YES then the physician should send an email to compassionateuse@livelikebella.org. Once the email is received, a physician from Biomarck Pharmaceuticals will respond directly to the treating oncologist to discuss the case. Additionally please click on the link below for further information.

For more information on compassionate use of this investigational drug, please contact your physician and have them email us at compassionateuse@livelikebella.org

Please click on the link below for important information regarding compassionate use of BIO-11006.

ABOUT BIOMARCK

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.

WAYS TO "LIVE LIKE BELLA"

  • Wear red
  • Show compassion
  • Pray for others
  • Eat S'mores
  • Belly laugh really loud
  • Sing at the top of your lungs
  • See a show
  • Play an instrument
  • Sing Jesus songs
  • Pray all the time
  • Cuddle
  • Take a bubble bath
  • Say mmmm when something tastes really good
  • Ride “It's a Small World” at Disney

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