Friday, November 24, 2017

Pharmaceutical Company Updates: Cyclacel, MannKind, Human Genome, BioTime, Bristol-Myers, RXi Pharma

Below is a list of the companies that made news in the healthcare sector on Thursday, June 10, 2010.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced today interim response data from a Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (also called MDS, and formerly known as “preleukemia”) that have failed hypomethylating agents. The data were presented at an oral poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting.

“There are no effective therapies for MDS after treatment failures of hypomethylating agents. Sapacitabine has demonstrated promising activity in this difficult to treat population which warrants further clinical development in MDS,” said Hagop M. Kantarjian, M.D., Chairman and Professor, Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas and study chair of the sapacitabine Phase 2 study.

“We are encouraged by the interim response data which indicates that sapacitabine is active in MDS patients after treatment with hypomethylating agents such as azacitidine or decitabine,” said Judy H. Chiao, M.D., Cyclacel’s Vice President, Clinical Development & Regulatory Affairs. “The primary efficacy endpoint of the study is 1-year survival. We look forward to reporting 1-year survival data toward the end of 2010.”

Shares of Cyclacel jumped more than 14% on the news, rising 20 cents to $1.62.

MannKind Corporation (NASDAQ: MNKD) today announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes. In addition, patients treated with AFREZZA had statistically significant lower rates of hypoglycemia, post-prandial glucose (PPG) levels when measured at 30, 60, 90 and 120 minutes, and fasting blood glucose (FBG) levels when compared to subcutaneously injected insulin lispro.

“Effectively controlling blood sugar levels and managing hypoglycemic events go hand in hand as key to successfully treating patients with Type 1 diabetes,” said Satish K. Garg, M.D., Professor, Departments of Pediatrics and Medicine, University of Colorado School of Medicine; Head, Young Adult Diabetes Clinic, Barbara Davis Center for Childhood Diabetes, and lead study investigator. “Our findings demonstrate that AFREZZA may offer a significant advance from current mealtime insulin delivery methods, as it is comparable to the standard of care in glycemic control and provides the additional benefit of lower hypoglycemia rates.”

Shares of MannKind rose more than 11% on the news, jumping 66 cents to $6.25.

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

The BLA submission includes the results of two pivotal Phase 3 clinical trials in autoantibody-positive patients with SLE showing that belimumab met its primary endpoint. In the Phase 3 studies, known as BLISS-52 and BLISS-76, belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated in BLISS-52 and BLISS-76, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups. The design of the two trials was similar, but the duration of therapy in the two studies was different – 52 weeks for BLISS-52 and 76 weeks for BLISS-76. HGS designed the Phase 3 program for belimumab in collaboration with GlaxoSmithKline (GSK) and leading international SLE experts, and in consultation with the FDA. The two studies treated a total of 1,684 patients.

“We and GSK have now submitted regulatory applications for BENLYSTA in both the United States and Europe,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Our companies will continue to work together to achieve licensure and bring this potentially important new therapeutic option to market. Based on the results of our pivotal Phase 3 studies, HGS believes BENLYSTA could become the first new approved drug for systemic lupus in more than 50 years.”

BioTime, Inc. (NYSE Amex: BTIM) announced today that it has organized a new subsidiary, OrthoCyte Corporation, for the purpose of developing novel therapeutics based on stem cell technology for the treatment of injuries and disorders affecting the musculoskeletal system, including therapeutics that would regenerate bone, cartilage, tendons and ligaments. BioTime will transfer certain patents and license certain technology to OrthoCyte for use in the field of orthopedic therapies.

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced that the companies have agreed to stop the Phase 3 AVERROES clinical trial of apixaban in patients with atrial fibrillation. The study will be stopped early because a predefined interim analysis by the independent Data Monitoring Committee (DMC) revealed clear evidence of a clinically important reduction in stroke and systemic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for vitamin K antagonist therapy who received apixaban as compared to aspirin. This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin.

RXi Pharmaceuticals Corporation (Nasdaq: RXII) today announced the company’s new focused RNAi therapeutic strategy at the Jefferies 2010 Global Life Sciences Conference.

RXi’s therapeutic platform has the potential to be broadly applicable to multiple therapeutic areas and indications. The company’s core focus leverages RXi’s unique technologies and competencies to advance potential candidates in select therapeutic areas with attractive market potential. RXi will also explore additional indications of strategic interest to the company which will be advanced internally and with partners through preclinical studies. As RXi executes on its core focus and strategic interest areas, additional areas may be pursued opportunistically.

Tags: , , , , ,

| More