|Repligen reports positive Phase III results. CBLI hits 52 week high. After the bell: Impax soars on Parkinson study data|
|By Mary Davila|
|Monday, 14 March 2011 18:53|
After the bell, shares of Impax Laboratories, Inc. (NASDAQ:IPXL), jumped more than 13% after the company's branded products division Impax Pharmaceuticals, announced statistically significant, positive, top-line results of the ADVANCE-Parkinson’s Disease (PD) Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations. The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD.
The primary endpoint of this comparison study of IPX066 to IR CD-LD was the percentage of "off time" during waking hours. IPX066 demonstrated a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD. "Off time" is the functional state when patients’ medication effect has worn off and there is a return of Parkinson’s symptoms.
After the bell shares of Impax jumped $2.93 or 13.23% to $25.00.
Repligen Corporation (NASDAQ:RGEN) reported today positive top-line results from a Phase 3 study to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with pancreatic disease using endoscopy (ERCP) as a diagnostic reference. The study's co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities with a loss in specificity of less than 7.5% by two of the three central radiologists reading the MRI images. In this study, all three radiologists achieved a clinically and statistically significant improvement in sensitivity with minimal loss in specificity. In addition, the RG1068-MRI images showed highly significant improvements on image quality, and confidence in the diagnostic findings, when compared to MRI alone. There were no serious adverse events (SAEs) or unscheduled days of hospitalization associated with the RG1068-MRI procedures compared to 55 SAEs and 236 days of unscheduled hospitalization associated with the ERCP procedures. The company expects to meet with the FDA to review the results and to plan a New Drug Application.
The stock traded as high as $4.07 intraday before settling at $3.64.
Shares of Cleveland BioLabs, Inc. (NASDAQ:CBLI) hit a new 52 week high on record volume today on the heals of the nuclear disaster unfolding in Japan. As reported earlier today on BioMedReports, the stock has been under accumulation recently as investors anticipate a grant from BARDA.
Shares of CBLI traded as high as $8.46 before pulling back, ending the day at $7.94, up 75 cents or 10.43%. More than 3 million shares traded hands. In extended trading, shares were up 21 cents to $8.15 on volume of 115k shares.
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) and Chroma Therapeutics Ltd. announced today that the companies have entered into a co-development and license agreement providing CTI with exclusive marketing and co-development rights to Chroma's drug candidate tosedostat in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. CTI, in collaboration with Chroma, expects to commence a phase III clinical study in the United States and Europe in elderly patients with relapsed or refractory acute myeloid leukemia ("AML") for potential approval by the U.S. Food and Drug Administration and the European Medicines Agency. The FDA and the EMA have granted tosedostat orphan drug status for AML. More than 42 million shares traded as the stock gained 6% to 32 cents.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it has signed a distribution agreement with Shanghai Haopu Medical Instruments Co. Ltd. to become a regional distributor of eVent Medical's inspiration ventilator in the Chinese market.
Under the agreement, Dehaier will sell eVent's inspiration ventilators to hospitals, clinics and medical facilities through its direct sales force and nationwide network of over 2,000 dealers and distributors. Shares gained 47 cents or 8% to $6.08.
AdCare Health Systems, Inc. (NYSE Amex: ADK), an Ohio-based long-term care, home care and management company, has been invited to present at the ROTH Capital Partners 23rd Annual OC Growth Stock Conference to be held at The Ritz Carlton in Dana Point, California on March 13-16, 2011.