Shares of Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) ended Friday session in green amid volatile trading. The shares closed up +0.14 points or 12.61% at $1.25 with 3.13 million shares getting traded. Post opening the session at $1.14, the shares hit an intraday low of $1.13 and an intraday high of $1.35 and the price vacillated in this range throughout the day. The company has a market cap of $116.65 million and the numbers of outstanding shares have been calculated to be 82.87 million shares.
Catalyst Pharmaceuticals Inc (CPRX) on Sept. 19, 2016 announced that the journal of Epilepsy & Behavior Case Reports has accepted for publication a case report on the efficacy of CPP-115 in a child with refractory infantile spasms.
The case report presents a child treated with CPP-115 through an investigational new drug protocol who experienced a significant reduction of seizures with no evidence of retinal dysfunction. The research paper made the following conclusions:
- The case study suggests sustained efficacy and tolerability of CPP-115 in treating epileptic spasms
- It reported reduction in seizure frequency and documented improvements in the EEG interictal and ictal record temporally associated with CPP-115 initiation for this patient
- It reported that in the context of refractory infantile spasms and associated morbidity, mortality, and poor neurodevelopmental outcomes, CPP-115 is potentially a promising alternative to vigabatrin therapy
Prior to treatment with CPP-115, the patient had failed ten drugs and the ketogenic diet, and had approximately 100 seizures per day. One year after starting CPP-115 and coming off of clobazam and vigabatrin, the patient’s reported seizures have seen a marked reduction in frequency and his cognition and behavior have improved.
“There is a significant unmet medical need in the area of refractory infantile spasms, as parents of children who have infantile spasms have a very difficult choice when it comes to treatment options, weighing both drug-related risks and adequate treatment,” said Patrick J. McEnany, Chairman and CEO of Catalyst. “Our pediatric epilepsy experts advise us that approximately half of the children diagnosed with infantile spasms are refractory to the medications approved for the treatment of infantile spasms.”
Shares of Celgene Corporation (NASDAQ:CELG) ended Friday session in red amid volatile trading. The shares closed down -1.14 points or -1.03% at $109.43 with 3.07 million shares getting traded. Post opening the session at $110.87, the shares hit an intraday low of $109.29 and an intraday high of $111.14 and the price vacillated in this range throughout the day. The company has a market cap of $83.95 billion and the numbers of outstanding shares have been calculated to be 775.11 million shares.
On September 16, 2016 Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (CELG), announced results from the 96-week blinded extension period (for a total of up to 120 weeks of exposure on treatment) of the RADIANCE phase 2 trial of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS).
“The data from this blinded extension are encouraging and further support evaluation of the benefit-risk profile of ozanimod in the ongoing phase 3 trials of patients with relapsing multiple sclerosis,” said Giancarlo Comi, MD, Professor of Neurology, Chairman of the Department of Neurology, and Director of the Institute of Experimental Neurology, at Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan.
As previously announced at ECTRIMS 2014, RADIANCE met its primary efficacy endpoint — reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions, as determined by MRI, from week 12 to week 24. In the blinded extension period of the study, patients originally randomized to ozanimod continued their assigned dose (0.5 mg, n = 85; 1 mg, n = 81), while patients in the placebo arm were randomized to either dose of ozanimod (0.5 mg, n = 41; 1 mg, n = 42). The extension week 96 visit was completed by 224 of the patients (90 percent) who entered the extension study.
At extension week 96, the mean number of GdE lesions was 0.3 for patients on the 0.5 mg dose and 0.1 for the 1 mg dose, compared with 0.4 and 0.1, respectively, at week 48. The proportion of patients who were free of GdE lesions was 91 percent for the 0.5 mg dose and 89 percent for the 1 mg dose. The cumulative number of new or enlarging T2-hyperintense lesions was 1.8 for the 0.5 mg dose and 0.6 for the 1 mg dose, compared with 1.3 and 0.7, respectively, at week 48.