Tag Archives: cancer vaccine

Bring Your Brave: Breast Cancer Awareness Month Begins Today!

braveDid you know that one in eight women in the U.S. will be diagnosed with breast cancer in her lifetime?  At that current rate, that means 13 million breast cancer deaths around the world will occur in the next 25 years.

The most significant risk factors for breast cancer are gender (being female) and age (growing older).  Other factors can be changed by making choices. By choosing the healthiest lifestyle options possible, you can empower yourself and make sure your breast cancer risk is as low as possible.

Reduce Risk Factors:

  • Do not smoke
  • Drink alcohol in moderation
  • Exercise at least three hours per week or about 30 minutes a day
  • Eat a nutritious, low-fat diet (30 grams or less) with plenty of fruits and green and orange vegetables

The National Breast Cancer Foundation launches the annual campaign by raising awareness during the month of October.  The endeavor begins today, October 1, 2016 and lasts through the end of the month.  Getting a high-quality screening mammogram and having a clinical breast exam on a regular basis are the most effective ways to detect breast cancer early.

Early Detection Strategies:

  1. Recognize signs & symptoms
  2. Perform a monthly breast self-exam (BSE)
  3. Have an annual clinical breast exam
  4. Screen for abnormalities with a mammogram

The American College of Radiology (ACR) has established a uniform way for radiologists to describe mammogram findings. The system, called BI-RADS, includes seven standardized categories, or levels. Each BI-RADS category has a follow-up plan associated with it to help radiologists and other physicians appropriately manage a patient’s care.

bi-rads

Some state and local health programs and employers provide mammograms free or at low cost. For example, the Centers for Disease Control and Prevention (CDC) coordinates the National Breast and Cervical Cancer Early Detection Program. This program provides screening services, including clinical breast exams and mammograms, to low-income, uninsured women throughout the United States and in several U.S. territories. Contact information for local programs is available on the CDC website or by calling 1–800–CDC–INFO (1–800–232–4636).

Information about free or low-cost mammography screening programs is also available from the National Cancer Institute’s (NCI’s) Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) and from local hospitals, health departments, women’s centers, or other community groups.

For more information:

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.