Benzinga | Aug 25, 2021 06:05AM EDT

Cassava Sciences Issues Response To Negative Claims Made Online

Cassava Sciences, Inc. (NASDAQ:SAVA), a biotechnology company focused on Alzheimer's disease, today issued a response to claims that were posted on-line yesterday after market hours. Cassava Sciences believes the claims made in this post regarding scientific integrity are false and misleading. The Company stands behind its science, its scientists and its scientific collaborators, and is responding to ensure the facts are known and respected.



"As a science company, we champion facts that can be evaluated and verified," said Remi Barbier, President & CEO. "This helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we wish to address allegations head-on."

Fiction Biomarker data is generated by Cassava Sciences or its science collaborators and therefore are falsified.

Fact Cassava Sciences' plasma p-tau data from Alzheimer's patients was generated by Quanterix Corp., an independent company, and presented at the recent Alzheimer's Association International Conference1.

Fiction Plasma p-tau for one individual Alzheimer's patient increased by 235%, which was not shown in the scatterplot.

Fact This patient's plasma p-tau increased by 38%, not 235%, as shown in a scatterplot.2

Fiction Tissue staining showing Abeta42 inside neurons shows treatment effects.

Fact Yes, Abeta42 is indeed inside neurons prior to plaque formation.

Fiction The author's Citizen Petition to FDA dated August 18, 2021, is evidence of wrongdoing.

Fact Five days after the Citizen's Petition, Cassava Sciences announced it had reached an agreement with FDA on Special Protocol Assessments (SPA) for its Phase 3 studies of simufilam for the treatment of Alzheimer's disease. The SPAs underscore alignment with FDA on key scientific, clinical and regulatory requirements of the Company's Phase 3 program of simufilam in Alzheimer's disease.3 Furthermore, a Citizen's Petition allows any party to raise safety/efficacy concerns with drugs the FDA is considering for approval, which is not the case for Cassava Sciences' simufilam.4

Fiction Extensive use of Western blot analysis is foundational to Cassava Sciences' research and therefore suspicious.

Fact Western blot analysis is foundational to the biotechnology industry5. Western blotting is a standard lab technique used world-wide to detect a protein of interest.

Fiction Cassava Sciences' Western blots data appear overexposed and highly processed, evidence of image manipulation.

Fact: High quality bands are supposed to look sharp6. Smudged bands can be evidence of inexperience, depending on levels of protein in the band.

Fiction Western blots data are identical, more evidence of image manipulation.

Fact The Western blots bands shown in the allegation are control bands. Control bands are supposed to be highly similar (since they show equal amounts of protein between lanes). Bands show clear differences when expanded. In addition, image manipulation of control bands makes no sense since these would not change the end data.

Fiction "Halo" effects in certain bands indicate fraud.

Fact A "Halo" effects in certain bands is a direct result of very dense dark loading control bands.7

Fiction Unusual looking bands on Western blots were pieced together from multiple sources.

Fact Proteins can and do stick to the side of a lane and migrate that way, resulting in 'candy-wrapper' appearance or other fictional images.

Fiction Femtomolar binding affinity is unusual and suspicious.

Fact Femtomolar binding affinity is a fundamental property of simufilam and may account for its relative potency and safety.

Fiction Post-mortem brain tissue that is dead for a decade is unreliable.

Fact Because of the inaccessibility of the human brain and its unavailability for biopsy, translational medicine can rely on post-mortem tissue8. In our case, human brain tissue was collected within 6 hours of death, flash-frozen and stored at -80 Centigrade. This is a standard procedure for pathologists. Such tissue processing is also used in cancer and other fields. Cassava Sciences is not aware of an industry-wide 'expiration date' on human post-mortem brain tissue that is properly collected, processed and stored.

Fiction Isoelectric focusing gels should not have crisp bands, which is evidence of fraud.

Fact Quality isoelectric focusing gels often do have crisp bands9.

Fiction Changes in the Y-maze test for transgenic mice could be interpreted as a decline in cognition.

Fact A panel of independent, peer-reviewers believe these changes represent an improvement, along with significant improvements in two other behavior tests.

Fiction High-affinity binding of naloxone for filamin A is suspicious.

Fact Naloxone binds the same site on filamin A. Of course, it will have high-affinity binding.

Fiction Isoelectric focusing experiments indicate 100% of filamin A is in altered conformation in Alzheimer's disease and is largely restored to correct conformation by simufilam.

Fact Cassava Sciences agrees. This nicely describes the mechanism of action for simufilam.

About Cassava Sciences, Inc.

Cassava Sciences' mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer's disease. For more information, please visit: https://www.CassavaSciences.com.