KEY CLINICAL OUTCOMES

Streamlined solutions provided by Cognitive Clinical Trials (CCT) related to the treatment and prevention of Alzheimer’s disease

Congnitive Clinical Trials (CCT) has introduced a new research model that prevail over the top obstacles being faced by the researchers related to the treatment and prevention of Alzheimer’s disease. The effective new model will focus on enrolling patients in the clinical trial who may otherwise be unable to participate due to concerns over travel, scheduling or health conditions. The company plans to accomplish this by embedding a clinical research infrastructure including physicians, clinical research coordinators and other research professionals.

Medicinova’s Phase III clinical trial plan for Ibudilast in ALS gets green signal from FDA

Medicinova’s developmental plan to evaluate ibudilast for amyotrophic lateral sclerosis (ALS) received approved by the United States Food and Drug Administration (USFDA). With the help of guidance and suggestions provided by the FDA, the company will design a trial whose aim will be to determine maximum benefit from the treatment. In order to achieve best results, FDA suggested that the upcoming Phase III trial should enroll broader number of participants and the randomization and data analysis should then be stratified according to a patient’s disease severity at the start of the study.

Moreover, it has been stated that if the researchers demonstrate a statistically significant benefit of ibudilast in patients’ functional activity over a placebo, as determined by changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score, the agency believes that further trials may not be necessary.

Ibudilast which is a small molecule that inhibits the activity of the phosphodiesterase-4 and -10 enzymes and the macrophage migration inhibitory factor has already been explored in a Phase II trial, wherein the drug was an adjunct to riluzole. The results of the Phase II trial indicated that addition of ibudilast to Rilutek significantly improved functional activity, quality of life, and muscle strength, compared with Rilutek alone. Moreover, no safety issues regarding ibudilast were reported, but safety will continued to be addressed in additional clinical studies.

Ibudilast is already marketed in Japan and Korea for bronchial asthma and post-stroke complications. And, the company is now exploring its potential in ALS, progressive multiple sclerosis, and substance addiction. The product has been designated as ‘orphan drug’ and granted fast-track status which will boost its clinical development and review, assisting in ibudilast’s potential approval.

Caladrius Biosciences falling out of pocket to advance Phase III CLBS14-RfA program

Caladrius Biosciences (CLBS) grabbed attention after it acquired the worldwide rights to Shire’s CD34+ stem cell therapy to treat medically refractory angina in March. Soon after, the therapy received the Regenerative Medicine Advanced Therapy (RMAT) status by the FDA. Although, a sustained increase of 40% in Caladrius’ share price was observed, the company paid an undisclosed but nominal upfront fee to Shire to acquire the program and further and expended little capital to obtain the RMAT designation. As a result of this, CLBS currently do not have financial resources or expertise to advance the acquired program.

Moreover, a recent meta-analysis of this therapy showed positive results, however the only Phase III study to-date, the RENEW trial, failed to meet its primary endpoint. Therefore, it is likely the regulatory agency will ask Caladrius to undertake a very costly and time-consuming Phase III trial in order to advance the CLBS14-RfA program.