|ZIOPHARM Shares Charge Higher After Phase 3 Trial of Palifosfamid; StemCells Shares Surge After First Patient Spinal Cord Injury Trial|
|By Staff and Wire Reports|
|Tuesday, 12 February 2013 19:42|
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) shares are up more than 14 percent Tuesday morning following results from the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma which reached its target number of progression-free survival (PFS) events. PICASSO 3 is an international, randomized, double-blind, placebo-controlled trial whose primary endpoint is PFS. According to the protocol and statistical plan, reaching the target number of PFS events leads to completion of the blinded data collection process and then formal efficacy analysis by the IDMC (Independent Data Monitoring Committee). The Company will announce topline results from this trial during the last week of March 2013.
"Reaching the target number of progression events for PICASSO 3 positions us one step closer to understanding palifosfamide's full potential for this significant unmet medical need," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "With a positive study outcome, palifosfamide has the potential to become the first new treatment option in nearly 30 years for patients with first-line metastatic soft tissue sarcoma."
StemCells, Inc. (Nasdaq: STEM) announced the twelve-month data from the first patient cohort in the Company's Phase I/II clinical trial of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) for chronic spinal cord injury continued to demonstrate a favorable safety profile, and showed that the considerable gains in sensory function observed in two of the three patients at the six-month assessment have persisted. The third patient remains stable. A summary of the data was presented today by Martin McGlynn, President and CEO, at the 15^th Annual BIO CEO & Investor Conference. By completing the twelve-month assessment, the first patient cohort has now completed the trial, and has entered into a separate follow-up study for long-term observation.
"The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury," said Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. "Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure. While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells. We are encouraged that the cells appear to convey clinical benefit in such severely injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation."
Patients in the study's first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation. Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient. Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.
AMRI (Nasdaq: AMRI) today reported financial and operating results for the fourth quarter and full year ended December 31, 2012.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Leerink Swann Global Healthcare Conference to be held February 13-14, 2013 at the Waldorf Astoria Hotel in New York City.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, will release results for the fourth quarter and full year 2012 on Tuesday, February 26, 2013 before the opening of the U.S. financial markets.
AVEO Oncology (NASDAQ:AVEO) and Astellas Pharma Inc. (TSE:4503) today announced overall survival (OS) for tivozanib, an investigational agent, from the Phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma (RCC).
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today that the Company was recognized with the "Best AEEDC Dubai Booth Activities Award" for the recent UAE International Dental Conference & Arab Dental Exhibition (AEEDC Dubai) held from February 5 - 7, 2013, in Dubai, United Arab Emirates.
BioMed Realty Trust, Inc. (NYSE: BMR) (the "Company"), a real estate investment trust (REIT) that delivers optimal real estate solutions for the life science industry, today announced that it delivered a notice of the Company's intention to redeem all 7,920,000 outstanding shares of its 7.375% Series A Cumulative Redeemable Preferred Stock (the "Series A preferred stock") (NYSE: BMRPrA; CUSIP No.: 09063H206) from the registered holders of the Series A preferred stock.
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL) for several of its over-the-counter medicines currently sold across Latin America, primarily in Mexico and Brazil.
Desert Gateway (OTCPK: RTRX), the parent company of Retrophin, Inc., a biotechnology company focused on discovering and developing treatments for rare and life-threatening diseases, today announced it has entered definitive agreements with institutional investors in connection with a private placement, or PIPE financing.
Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the fourth quarter and fiscal year ended December 31, 2012.
GTx, Inc. (Nasdaq: GTXI) announced today a webcast discussing Capesaris®(GTx-758) and it’s potential role in the treatment of advanced prostate cancer in men is scheduled for Friday, February 15th 2013, from 9:00am – 10:00am Eastern Time.
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that it has completed patient enrollment in the first stage of its NORTH two-stage Phase II trial.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, will discuss preservative-free medication dispensing at Pharmapack Europe, Paris, on 14 February at 09:55 CET.
The Medicines Company (NASDAQ: MDCO) has scheduled its quarterly conference call for Wednesday, February 20 at 8:30 a.m. Eastern Time to discuss fourth quarter and full year 2012 financial results, operational developments, and outlook for 2013.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Peter N. Kellogg, executive vice president and chief financial officer, Merck, is scheduled to present at the Leerink Swann 2013 Global Healthcare Conference in New York on February 13 at 11:30 a.m. EST.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it has filed a United States Letter Patent application for a novel drug delivery system based on its Smart Surface technology.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment.
Oragenics, Inc. (OTCBB: OGEN) announced today that its Exclusive Channel Collaboration (ECC) with Intrexon Corporation, a synthetic biology company, has produced an exponential increase in the fermentation titer of the target compound MU1140 and the discovery of a promising new purification process for this product.
Quantum Materials Corporation (QMC) (OTCQB:QTMM) announces a new class of cadmium-free, non-REE, non-heavy metal tetrapod quantum dots (NHM-TPQD) developed to meet worldwide concerns regarding nanoparticle biocompatibility and sustainability.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today financial results for the fourth quarter and full year ended December 31, 2012.
RQx Pharmaceuticals, Inc. today announced that it has entered into a drug discovery collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the discovery and development of novel drug compounds for an undisclosed target.
Sigma-Aldrich® Corporation (NASDAQ: SIAL), a leading Life Science and High Technology Company, announced that Sigma® Life Science, its innovative biological products and services business, signed an agreement to distribute worldwide Olink Bioscience's Duolink® In Situ products, which present a new disruptive method for imaging and measuring protein-protein interactions in unmodified cells.
Sirona Biochem Corp. (TSX VENTURE:SBM) (OTCQX:SRBCF) (FRANKFURT:ZSB) announced today its skin lightening compounds, TFC-849 and TFC-723, were proven to be safe in an ocular tolerability study.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the fourth quarter and fiscal year 2012 financial results, provide an update on the Company's business, and discuss expectations for the future.
Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM), a biotechnology company that develops and distributes prescription medical foods to physicians and pharmacies, today announced it has been issued patent number 8370172 from the United States Patent and Trademark Office.
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2012.