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Sentry employees and vendor partners as well as their families and friends shared time together at the Indianapolis Indians game on September 13, 2022. While the Indians battled the Toledo Mud Hens, the Sentry team enjoyed ballpark hot dogs, brisket, macaroni and cheese, fresh fruit, barbeque,...
Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development.
Sentry Biopharma Services specializes in the storage and global distribution of temperature sensitive biopharmaceutical...
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.
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 Sentryvia email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.
Sentry BioPharma Services provides oncology product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting. Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both cancer clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. With this in mind, the most successful cancer drugs are no match for avoidance of cancer altogether. Therefore, we are sharing this article from the National Institute for Health (NIH) concerning a new study which links physical exercise with lower cancer rates.
A new study of the relationship between physical activity and cancer has shown that greater levels of leisure-time physical activity were associated with a lower risk of developing 13 different types of cancer. The risk of developing seven cancer types was 20 percent (or more) lower among the most active participants (90th percentile of activity) as compared with the least active participants (10th percentile of activity). These findings, from researchers at the National Cancer Institute (NCI), part of the NIH, and the American Cancer Society (ACS), confirm and extend the evidence for a benefit of physical activity on cancer risk and support its role as a key component of population-wide cancer prevention and control efforts. The study, by Steven C. Moore, Ph.D., NCI, and colleagues, appeared May 16, 2016, in JAMA Internal Medicine.
Hundreds of previous studies have examined associations between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers; however, results have been inconclusive for most cancer types due to small numbers of participants in the studies. This new study pooled data on 1.44 million people, ages 19 to 98, from the United States and Europe, and was able to examine a broad range of cancers, including rare malignancies. Participants were followed for a median of 11 years during which 187,000 new cases of cancer occurred.
The investigators confirmed that leisure-time physical activity, as assessed by self-reported surveys, was associated with a lower risk of colon, breast, and endometrial cancers. They also determined that leisure-time physical activity was associated with a lower risk of 10 additional cancers, with the greatest risk reductions for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Myeloma and cancers of the head and neck, rectum, and bladder also showed reduced risks that were significant, but not as strong. Risk was reduced for lung cancer, but only for current and former smokers; the reasons for this are still being studied.
“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Moore. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”
Leisure-time physical activity is defined as exercise done at one’s own discretion, often to improve or maintain fitness or health. Examples include walking, running, swimming, and other moderate to vigorous intensity activities. The median level of activity in the study was about 150 minutes of moderate-intensity activity per week, which is comparable to the current recommended minimum level of physical activity for the U.S. population.
There are a number of mechanisms through which physical activity could affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by three metabolic pathways that are also affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.
Most associations between physical activity and lower cancer risk changed little when adjusted for body mass index, suggesting that physical activity acts through mechanisms other than lowering body weight to reduce cancer risk. Associations between physical activity and cancer were also similar in subgroups of normal weight and overweight participants, and in current smokers or people who never smoked.
The study was a large-scale effort of the Physical Activity Collaboration of NCI’s Cohort Consortium, which was formed to estimate physical activity and disease associations using pooled prospective data and a standardized analytical approach.
“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said Alpa V. Patel, Ph.D., a co-author from the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”
The National Cancer Institute leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at https://www.cancer.gov or call NCI’s Cancer Information Service at 1-800-4-CANCER.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Moore SC, et al. Leisure-time physical activity and risk of 26 types of cancer in 1.44 million adults. JAMA Internal Medicine. May 16, 2016. DOI:10.1001/jamainternmed.2016.1548.
Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated GMP storage and temperature-sensitive drug distribution services. For more information about how Sentry’s GMP storage can help protect the integrity of your biological products in general, contact Sentryvia email or by phone at 1-866-757-7400.