Warnings that stopping Gilenya® could make multiple sclerosis worse: industry news round-up

Written by Sharon Salt, Editor

In this week’s industry news round-up we cover the latest headlines on multiple sclerosis, glioblastoma and illegal marketing of dietary supplements containing antidepressants. Find out more about our selection of the highlights below.
Our selection of the highlights includes:

BrainStorm Cell Therapeutics submits IND for NurOwn® in progressive multiple sclerosis

BrainStorm Cell Therapeutics (NY, USA) has announced that it has submitted an Investigational New Drug (IND) application with the US FDA to initiate a Phase II study of NurOwn® in patients with progressive multiple sclerosis (MS).

“We plan to quickly initiate the Phase II clinical study of NurOwn in progressive MS to address the significant unmet need for MS patients,” commented Ralph Kern, Chief Operating Officer and Chief Medical Officer of BrainStorm. “We believe the demonstrated safety and efficacy experience of NurOwn in our amyotrophic lateral sclerosis clinical program and development of neurotrophic factors and other efficacy biomarkers will allow us to confidently expand our cellular therapy pipeline.”

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Source: http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2377637

TRC102 and Temodar® fail to meet primary endpoint in Phase II glioblastoma trial

At the Society for Neuro-Oncology (SNO) Annual Meeting (15–18 November 2018, New Orleans, LA, USA), TRACON Pharmaceuticals (CA, USA) presented data from the company’s Phase II study of TRC102 and Temodar® (temozolomide) in patients with recurrent glioblastoma.

TRC102 is a small molecule inhibitor of the base excision repair (BER) pathway that causes resistance to Temodar chemotherapy in preclinical tumor models.

Safety and efficacy data were presented from patients who received TRC102 and Temodar at the time of recurrence following first-line therapy with Temodar chemotherapy and radiation therapy. The combination of TRC102 and Temodar was reported to be tolerable, but did not meet the primary efficacy endpoint of demonstrating objective responses by the Response Assessment in Neuro-Oncology criteria in the initial 19 enrolled patients.

“We recognized that the primary endpoint of objective response in the Phase II trial of Temodar and TRC102 represented a high-efficacy hurdle, that of resensitizing recurrent glioblastoma patients to Temodar treatment. We were encouraged to see certain patients demonstrate prolonged clinical benefit that was associated with evidence of activation of the BER pathway of resistance that is inhibited by TRC102,” commented Charles Theuer, President and CEO of TRACON Pharmaceuticals.

Theuer concluded that: “Our efforts will continue to focus on identifying possible biomarkers that are prognostic of response to TRC102 in four ongoing clinical trials supported by the National Cancer Institute.”

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Source: https://traconpharma.gcs-web.com/news-releases/news-release-details/tracon-pharmaceuticals-presents-data-phase-2-trial-trc102-and

Warnings that stopping Gilenya® could make multiple sclerosis worse

 The US FDA has warned that when the MS medication Gilenya® (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken.

“This MS worsening is rare but can result in permanent disability. As a result, we have added a new warning about this risk to the prescribing information of the Gilenya drug label and patient medication guide,” said the FDA. They have advised that healthcare professionals should inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.

The FDA has also reported that the severe increase in disability in these patients was more severe than typical MS relapses, and in cases where baseline disability was known, appeared unrelated to the patients’ prior disease state.

Additionally, several patients who were able to walk without assistance prior to discontinuing Gilenya progressed to needing wheelchairs or became totally bedbound. The FDA further reported that in patients experiencing worsening of disability after stopping Gilenya, recovery varied – 17 patients had partial recovery, eight experienced permanent disability or no recovery, and 6 eventually returned to the level of disability they had before or during Gilenya treatment.

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Source: www.fda.gov/Drugs/DrugSafety/ucm626095.htm

Illegal marketing of dietary supplements containing antidepressants receives US FDA warning

The FDA has posted warning letters issued to two companies for the illegal marketing of produces labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treated opioid use disorder.

“In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder. They’re also selling products with known safety issues. We won’t stand by and allow this to happen. These warning letters are one part of our enforcement plan and we’ll continue to take action to protect public health,” said FDA Commissioner Scott Gottlieb.

Tianeptine is currently approved to treat depression in other countries. However, taking it has been reported to have significant health effects, including neurologic, cardiovascular and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal.

The US Centers for Disease Control and Prevention reported that there has been a rise in tianeptine exposure calls to US poison control centers during 2014–2017, suggesting a possible emerging public health risk.

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Source: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626349.htm