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.

Reprint by permission PRNewswire; T-Cell Image Creative Commons License BY-SA

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Consumer Warning for Erectile Dysfunction Pills

The FDA confirmed that consumers have received these drugs, without a prescription, which contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients including the elderly and those with impaired liver and kidney function. When sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, a person’s blood pressure can reach dangerously low levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Do not use these products. If you have used these products and became ill or otherwise experienced an adverse event, contact your health care provider. FDA continues to warn consumers that medications purchased from unapproved and/or unlicensed sources may be dangerous as they can be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.

The label on the blister packs for these unapproved drugs states that the products are manufactured in India by Acme Generics. The label also bears the name Sun Pharma. FDA is concerned the seller may also be distributing to U.S. consumers unapproved tadalafil as a generic for the prescription drug Cialis.

Adverse Events
To date, FDA is not aware of any adverse events associated with these particular unapproved versions of sildenafil or tadalifil. Health care professionals and consumers should report any adverse events related to this product to FDA’s MedWatch. Adverse Event Reporting program by:
•  Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
•  Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

Reprint by permission of FDA (Online Public Domain); Image courtesy of FDA Free License PubDom

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3D Printing for Medical Devices

3D printing is a process that creates a three-dimensional object by building successive layers of raw material.

Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).  The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

In the picture, models have been 3D-printed for (left to right, top) a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. Due to its versatility, 3D printing has medical applications in:
• Medical devices – regulated by FDA’s Center for Devices and Radiological Health (CDRH)
• Biologics – regulated by FDA’s Center for Biologics Evaluation and Research
• Drugs – regulated by FDA’s Center for Drug Evaluation and Research

Medical device manufacturers should refer to FDA guidance documents and Quality Systems regulations for more information on specific applications.

Additional Resources (see link) are available, including:
• The 3Rs of 3D Printing: FDA’s Role
Learn how the FDA reviews and researches 3D printed medical products to protect the public health.
• How 3D Printers Work
A resource from the Department of Energy and includes descriptions of different types of printing processes
• NIH 3D Print Exchange
Offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science. The goal of the project is to facilitate the application of 3D printing in the biosciences.
• American Society of the International Association for Testing and Materials (ASTM)
This is a collaborative, consensus organization that has published standards and test methods for additive manufacturing and 3D printing.
• America Make
A public private partnership whose members, including the FDA, are working together to innovate and accelerate 3D printing to increase our nation’s global manufacturing competitiveness.

Reprint by permission of FDA (Online Public Domain); Image courtesy of FDA Free License PubDom

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