FDA Releases Clinical Trial Guidelines Taking into Account CNS Metastases

The Food and Drug Administration recently released new guidance informing sponsors of clinical trials on recommendations to trial designs for systemic oncologic treatments in individuals with central nervous system metastases. According to the new guidelines, researchers must consider leptomeningeal disease, end points, central nervous system assessment, prior therapies and patient population when designing clinical trials. The assessment of tumors is best done through magnetic resonance imaging (“MRI”) with gadolinium contrast.

The agency recommends that the involvement of the central nervous system (“CNS”) not be assessed separately from other metastatic illnesses present in other parts of a patient’s body. It adds that limited effectiveness reporting, including progression-free survival or overall response rate, even when supported by discoveries from central nervous system metastatic groups, is unsuitable when presented alone because it doesn’t take into account any other central nervous system ailments.

The new guidelines also recommend case reports of all CNS-directed therapies, including brain radiation therapy, stereotactic radiosurgery and surgery, be included when assessing previous treatments. A patient’s response to treatments and therapy dates should also be recorded in the reports.

The agency suggests that intervals between trial entry and CNS radiation therapy completion be included, with a regular interval being about 12 weeks. It also highlights that any amendments made to standard response criteria be justified. In addition to this, the new recommendations mandate that sponsors of clinical trials provide radiology charters describing sequences and imaging modalities, as well as other standard parameters applied at every trial site.

Furthermore, all case reports will have to include baseline data and data on variables captured during the study, which may influence radiologic response interpretation. This includes changes in antiseizure drugs or current antiseizure drugs being used, change in use of steroids or current use of steroids, and changes in neurologic symptoms or presence of said symptoms.

The agency also recognizes leptomeningeal disease as a disease of the central nervous system. In its recommendations, it emphasizes the need for clinical trials evaluating the effects of drugs on leptomeningeal disease also assess parenchymal disease.

The guidelines highlight that an analysis of cerebrospinal fluid and imaging can be used to identify leptomeningeal disease. It recommends that patients who may have the disease based on clinical symptoms but without imaging findings should undergo cerebrospinal fluid analysis to support their diagnosis.

With regard to end points for clinical trials, the FDA recommends that researchers refer to the industry guidance on clinical trial end point for approval of biologics and cancer drugs.

These guidelines are likely to be of significance to companies such as CNS Pharmaceuticals Inc. (NASDAQ: CNSP), which is engaged in R&D projects focused on taking the treatment of brain cancers to the next level.

NOTE TO INVESTORS: The latest news and updates relating to CNS Pharmaceuticals Inc. (NASDAQ: CNSP) are available in the company’s newsroom at https://ibn.fm/CNSP

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