Tracking COVID-19 Vaccine Development Efforts Across the Globe

The past year has seen the rapid global spread of SARS-CoV-2—the virus responsible for the ongoing COVID-19 pandemic. While non-pharmaceutical interventions have been the mainstay of epidemic control to date, vaccination is likely to constitute the definitive, long-term defence strategy against SARS-CoV-2 morbidity, mortality, and transmission, offering the best hope of a return to normal life.

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What’s New in Breast Cancer Research and Treatment?

Criterium’s Academic Breast Cancer Consortium (ABRCC) is comprised of 15 renowned academic and community sites in North America, conducting translational research in Breast Cancer studies for major pharmaceutical companies who are working on the most current clinical trials for advanced treatments of breast cancer. While 2020 was a year dominated by COVID-19 news and tragedy, breast cancer research and breakthroughs can’t wait for COVID to “go away” – and research in this area continues on full-speed. Our ABRCC researchers reflect on 2020 and look ahead to 2021 with renewed hope.

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Podcast: ‘You Have to Personalize the Miracles’

For November’s Lung Cancer Awareness Month, Heather Smith and Melissa Turner share the stories of their cancer journeys. The women took very different routes to the CU Cancer Center and the world-renowned lung cancer care of Ross Camidge, MD. On this episode of the CU Anschutz 360 podcast, learn why they love everything about Dr. Camidge’s practice, especially the fact that he makes them laugh.

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Positive Trial Data with 100% Safe Delivery

Moleculin Announces Positive Trial Data with 100% Safe Delivery of p-STAT3 Inhibitor and Efficacy in Majority of Patients

Preliminary results from phase 1 clinical trial of WP1220 for treatment of cutaneous T-cell lymphoma (“CTCL”); supports phase 2 study.

“For years, p-STAT3 (the activated form of STAT3) has been considered an ‘undruggable’ target because of the difficulty of reaching and affecting this cell-signaling protein,” commented Walter Klemp, Moleculin’s Chairman and CEO. “Some consider it to be a master regulator of cancer-related gene transcription, so we believe the ability to show a therapeutic effect from a p-STAT3 inhibitor could be considered a significant breakthrough in cancer research.”

Results: There were 6 patients screened, and 5 patients enrolled between March and July 2019. Three are evaluable for both safety and efficacy after completing 3 months of treatment, with 2 ongoing and evaluable for safety. The only AE reported potentially related to study drug in one of the five patients was a mild contact dermatitis not requiring treatment. CAILS scores on index lesions were significantly decreased in the first 3 patients, who were stages IA, IB, and IIB, respectively, at entry. A composite score was obtained for all treated lesions for each patient, and percent changes were calculated from baseline to Day 84. There was a median reduction of 70.8% (range 62.1%-76.2%) for the 3 patients. Improvement was noted as early as 7 days after initiation of treatment, and maintenance of improvement was also shown at follow up (1 month after discontinuation, as per protocol). The fourth patient has also shown an initial reduction in the composite CAILS score after 56 days (26.7%), and is continuing on treatment. Evaluations of the biopsy samples for histopathology and status of p-STAT3 in treated lesions are in progress.

Conclusions: WP1220, an inhibitor of p-STAT3, has shown demonstrable safety and significant efficacy after at least 3 months of topical treatment in 3 patients with progressive MF, with a continuing trend towards improvement in additional patients currently in treatment. This is the first demonstration that inhibition of the STAT3 activation pathway with topical therapy has impacted the course of this disease. The trial is continuing, and updated and more comprehensive data from this study as well as assessment of STAT3 phosphorylation in treated lesions will be reported.

“This is the first topical delivery of a p-STAT3 inhibitor that we know of for CTCL, where there is a significant unmet need for improved treatment of the lesions associated with this potentially deadly skin cancer. But, we believe the significance of this data goes well beyond CTCL, as it speaks to the targeting of p-STAT3 as a general strategy. We are excited to share these preliminary results in association with ASH, especially because we believe showing activity here could have exciting implications for the future of STAT3 inhibitors in general. Although this is a relatively small pilot study, we believe the results justify an expansion to a larger patient population in a Phase 2 clinical trial,” added Dr. Sandra Silberman, CMO at Moleculin.

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New Public Health Crisis? Study Urged on Marijuana Smoking & Lung Cancer

As marijuana becomes mainstream and usage rates skyrocket, some of the nation’s top cancer doctors are urging the Surgeon General to investigate the link between smoking marijuana and lung cancer.

Among the renowned doctors calling for more study is Dr. Joseph Friedberg, head of the Division of Thoracic Surgery at the University of Maryland School of Medicine. Publishing his concerns on SurvivorNet, the cancer site providing the latest information and treatment options from foremost cancer experts, Dr. Friedberg is calling for a federal study citing increased rates of lung cancer in their practices from patients whose only discernible risk factor is marijuana smoking. SurvivorNet released a documentary outlining the concerns surrounding the lack of research on the link between smoking marijuana and lung cancer in hopes of bringing widespread attention to the need for this study.

Dr. Friedberg states “Given the expanding legalization of marijuana, and the anticipated wave of increased use, there is clearly a need to study the cancer risks of marijuana with the same rigor that has been devoted to tobacco smoke. Both types of smoke contain some of the same carcinogens, so the widely held belief that tobacco smoke causes cancer and marijuana smoke does not is inherently flawed. “We have an opportunity to avoid a potential marijuana-related public health crisis similar to what we are still dealing with from cigarettes being introduced to the public without any health risk warnings.”

Previously, the only study on long term use of cannabis and lung cancer was a 2008 NIH study conducted in New Zealand which found that long term cannabis use increases the risk of lung cancer in young adults. The study cites other reputable scientific findings that state cannabis smoke is similar to tobacco smoke but with twice as many carcinogens and because people smoke joints without filters and hold the smoke in their lungs longer it can increase the risk of lung cancer. The major finding from this study was that for each joint-year of cannabis exposure, the risk of lung cancer increased by 8%, after adjustment for confounding variables including tobacco smoking.

A major differential risk between cannabis and cigarette smoking was observed, with 1 joint of cannabis similar to about 20 cigarettes for risk of lung cancer. This study was not extensive or long enough to be definitive but it raises concerns about the drug. This study would be the first of its kind to bring groundbreaking research and information to millions of Americans who smoke marijuana without understanding the potentially lethal side effects. Much like tobacco’s earliest days, if something is not done about this now, we risk another major health emergency.

SurvivorNet was founded to fill an urgent need for better information about cancer prevention and treatment. “By bringing attention to crucial findings from some of the country’s leading cancer doctors, we are hoping to save lives. We know marijuana is alleviating suffering for a great many cancer patients. We also think people who smoke and vape marijuana recreationally should have accurate information about whether there is an increased risk for cancer and then make their own choices. It’s clear a major national study is needed so we can really understand this issue.”

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The Emerging Breast Imaging Standard

Many breast imaging centers have launched high risk screening clinics to augment their existing services. This has already become the new standard, as organizations look for justification to expand patient services, recommend breast MRI screening exams, and provide referrals for genetic counseling.  Offering a service dedicated to screening patients for high risk, without the proper tools, can put more stress on the breast imaging workflow.

The problem is that many systems are not set up to function on this plane. Subsequently, some sites resort to manual data entry on risk model websites to calculate each score individually. Calculated risk models, such as Tyrer-Cuzick and the Gail Model, are simply not built into the RIS mammography tracking module, mammography information system, or EMR module.

Some programs offer standalone, web-based risk platforms only, although this method adds to system fragmentation, redundancy, and increased room for error. This is especially true when the reader wants to add the risk score to their finding report, or if the site wants to include risk-related information in the patient notification letter.

Tyrer-Cuzick version 8 has 25 elements and family history factors alone, so the time required to enter this for every patient, every study, and every day adds up fast. In most cases, the facility is already required to enter this information into their existing mammography tracking solution and, in order to generate the risk score, that same information has to be re-entered into an online calculator.

MagView, however, has considered this workflow and incorporated several breast cancer risk models into their base program. They offer automated calculations for all available risk models, such as Tyrer-Cuzick, Gail, BRCAPro, and Claus. In their program, patients can enter breast cancer risk factors in advance of the appointment using a patient history portal, saving the facility staff countless hours a day. The patients can also use the patient history tablet module for electronic submission to the breast center and MagView system.

These factors are saved from year to year, so the patient only needs to modify any changes in the previous history on subsequent visits. The calculators are built into the program, so no external websites or third-party programs are needed. The data is then used in the automatic risk calculation, and the radiologists can see the score in real-time, affecting their decision on follow-up recommendation. Scores can automatically be included in the finding reports, saving the readers additional time, and patients can be notified with automated text inserted into the letter based on their score.

Evidence has shown that including risk information in both the finding reports and patient letters has increased awareness along all fronts, especially when qualifying patients for additional imaging, like breast MRIs. One site reported a 100% increase in breast MRI referrals from their previous workflow using their RIS mammography tracking module as a reporting tool.

The bottom line is, increased high risk screening has improved the detection of cancers by ensuring patients who are at a high risk receive the care and additional imaging they need. In a recent study of BRCA mutation carriers and women of 20% or higher lifetime risk for breast cancer, sensitivity for breast cancer detection was 90.0% using MRI versus 37.5% for mammography and 37.5% for ultrasound (Source: Journal of Clinical Oncology. 2015;33(10):1128-35).

Reprint by permission of PRNewswire; Image courtesy of Ed Uthman via flickr CC 2.0

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