Tag Archives: U.S. Food & Drug Administration (FDA)

Sentry Promotes the WHO’s 2016 World Hepatitis Day

Today, July 28, 2016, Sentry BioPharma Services joins the World Health Organization (WHO) in promoting 2016 World Hepatitis Day by raising public awareness about this preventable and curable disease.

According to the WHO, “Viral hepatitis infection is widely spread, affecting 400 million people worldwide – over 10 times the number of people infected with HIV. Globally, about 1.4 million people die each year from hepatitis. It is estimated that only 5% of people with chronic hepatitis know of their infection, and less than 1% have access to treatment.

Yet, hepatitis is fully preventable and treatable. There are effective vaccines and treatments for Hepatitis B, and over 90% of people with Hepatitis C can be cured with treatment. The vision of eliminating hepatitis as a public health threat by 2030 can be achieved, if people and countries affected by this disease were better equipped and enabled to “know hepatitis” and “act now”.

Globally, most people who need treatment have not been treated, largely due to a lack of awareness, and access to hepatitis treatment services.  Over 90% of people with Hepatitis C can be completely cured of the virus within 3–6 months.  Appropriate treatment of Hepatitis B and C can prevent the development of the major life-threatening complications of chronic liver disease: cirrhosis and liver cancer.”

The U.S. Food and Drug Administration (FDA) approved seven (7) therapies to treat Hepatitis B and twelve (12) therapies to treat Hepatitis C.

FDA Approved Treatments for Hepatitis B

hepB

FDA Approved Treatments for Hepatitis C

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Sentry BioPharma Services offers GMP storage and global drug distribution services to protect your refrigerated inventory throughout the pharmaceutical and biological product supply chain.  For more information about how Sentry’s temperature-controlled storage and proven drug distribution system can protect the supply of your hepatitis therapy, contact Sentry via email or by phone at 1-866-757-7400.

FDA Removes Clinical Hold on Phase II of Juno’s “ROCKET” Trial

On Tuesday, July 12, 2016, Juno Therapeutics, a biopharmaceutical company developing cell-based cancer immunotherapies headquartered in Seattle, Washington, announced on the company’s website that the U.S. Food and Drug Administration (FDA) removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

CAR-T

Earlier this month Juno received notice from the (FDA) that a clinical trial hold has been placed on the pivotal clinical trial of JCAR015.  This Phase II clinical trial, also known as the “ROCKET” trial, was being conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  As of last Friday, a total of three deaths have occurred in adult patients during clinical trials.

According to an article published by FierceBiotech on July 8, 2016, “All three deaths were in young patients, all under the age of 25, and all were due to cerebral edema.  All three of these patients were also on a preconditioning regimen of fludarabine.”

While this “living drug” may offer cancer patients a possible option where none previously existed, it is uncertain as to whether or not the class of chimeric antigen receptor T cells (CAR-T) treatments poses safety issues.  This new technology focuses on re-engaging a patient’s own immune system (T cells) via genetically engineering to recognize the antigen and kill cancerous cells.  One big question is:  Can this be done in conjunction with standard leukemia chemotherapy drugs like fludarabine and cyclophosphamide?

The removal of the clinical hold suggests that the FDA appears to satisfied with Juno’s response in addressing worrisome side effect and safety concerns resulting from the reaction between JCAR015 and the chemotherapy drug fludarabine.

Phase I of the JCAR015 study had a “complete response rate” (i.e., detectable cancer did not appear present after treatment), this cancer treatment offers much promise and hope to individuals and families battling this devastating and too often fatal disease.

For more information about how Sentry can implement a custom solution to provide GMP storage for clinical trial materials and/or meet your unique biopharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.