|Nile Therapeutics gets FDA Fast Track. CytoSorbents soars on E.U. CE Mark. Radient moves higher on cancer test results. After the bell: Omeros tanks after failed study|
|By BioMedReports.com Staff|
|Thursday, 31 March 2011 19:14|
After the bell Thursday, shares of Omeros Corporation (NASDAQ:OMER) fell as much as 40% after the company reported that a late stage study for it's experimental drug to reduce pain after arthroscopic knee surgeries failed to meet primary endpoints. The company said that no conclusions could be made regarding drug effect due to confounding factors in the studies. "Given the strength of the data from previous clinical studies of OMS103HP, we are obviously disappointed and surprised by the outcome. Our analysis of the data does not demonstrate a lack of drug effect nor does it appear to undermine the viability of our Phase 3-ready OMS103HP program for meniscectomy surgery," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. A mid-stage study last year produced results showing that the drug, which is added to arthroscopic irrigation solution to improve post-operative joint function and motion and reduce pain, was well-tolerated.
In extended trading, shares were down $3.05 or 38% to $4.95.
After the bell, shares of AVI BioPharma, Inc. (NASDAQ:AVII) slumped after the company announced that intends to sell shares of its common stock in an underwritten public offering. In extended trading, shares fell 23 cents or 12% to $1.63.
After the market closed Thursday, Corcept Therapeutics Incorporated (NASDAQ:CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, announced that it will submit its NDA for the use of CORLUX in Cushing's Syndrome to the FDA the week of April 11, 2011.
Shares of Nile Therapeutics, Inc. (Nasdaq:NLTX) surged higher today after the biopharmaceutical company that develops novel therapeutics for heart failure patients, announced that the FDA has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.
As previously announced, Nile plans to develop cenderitide as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital. This is a novel therapeutic indication that is being referred to as "post-acute."
"We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer. "If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars."
Shares of Nile Therapeutics soared 21 cents or 34% to $0.82.
Shares of CytoSorbents Corporation (OTC.BB:CTSO) soared today after the critical care focused company using blood purification to treat life-threatening illnesses, announced that it has achieved European CE Mark approval for its flagship product, CytoSorb, as an extracorporeal cytokine filter in situations where excessive cytokine levels exist. This milestone certifies that CytoSorb has met the safety and label efficacy claim requirements of the European Medical Devices Directive and can now be sold in the European Union (E.U.) for human clinical use.
Dr. Phillip Chan, Chief Executive Officer, stated, "Obtaining European regulatory approval for CytoSorb is the most significant accomplishment in our company's history" Dr. Chan continued, "Now that we are permitted to manufacture CytoSorb devices for clinical use in the E.U. under CE Mark approval and ISO 13485 certification, we will ramp manufacturing for a controlled-market release in select territories in the second half of this year. The goal for 2011 is to build a solid foundation for future growth and responsibly make the transition from a development stage to a commercial stage medical device company. Our longer term goal is to pursue trials in the U.S. and attain FDA regulatory approval as well." Dr. Chan concluded, "With this major milestone, we continue to advance our mission to change the face of critical care medicine and to help save patients' lives."
More than 22 million shares traded as the stock soared 128% or 22 cents to $0.39.
Shares of Radient Pharmaceuticals Corporation (AMEX:RPC) surged higher today after the company announced preliminary results from its clinical study conducted in collaboration with a well-recognized, large third-party not-for-profit group practice and its affiliates for the validation of RPC's US FDA-cleared Onko-Sure® in vitro diagnostic (IVD) cancer test.
The purpose of the study was to determine the effectiveness of Onko-Sure® (DR-70) as a useful tool in the detection of colorectal cancer in all stages of colorectal cancer (CRC), especially early stages where effective diagnosis leads to better patient prognosis. In addition, this study focused on the effectiveness of Onko-Sure®, Carcinoembryonic Antigen (CEA) and the combination of these two tumor markers for additional clinical value. Based on preliminary results, RPC's Onko-Sure® IVD cancer test shows a statistical advantage over CEA in detecting CRC in the early stages of colorectal cancer. Furthermore, when Onko-Sure® was combined with CEA, the sensitivity of the combined test was substantially improved as opposed to using CEA alone.
Shares of Radient traded as high as 67 cents before settling the day at $0.54, up 8.5 cents or 19%.
ImmunoCellular Therapeutics, Ltd. (OTCBB:IMUC.ob), a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, announced today that ICT-107 was selected by R&D Directions editors for the magazine’s 10th annual list of "100 Great Investigational Drugs" featured as the cover article in the March 2011 issue. ICT-107 is the company’s dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme(GBM). Editors selected compounds that "show particular promise in a major or growing therapeutic area of unmet medical need, are actively in development, and target disease pathways using a distinctly innovative mechanism of action."
Inhibitex, Inc. (Nasdaq:INHX) today reported positive top-line safety and antiviral data from its multiple ascending dose Phase 1b clinical trial of INX-189, an oral nucleotide polymerase inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV). Shares gained 40 cents or 12.4% to $3.62.
NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) announced today that the Company has been invited to present the results of a recent QTinno performance study at an upcoming conference entitled "Cardiovascular Safety in Drug Development: State-of-the-Art Assessments," sponsored by the U.S. Food and Drug Administration (FDA), the Cardiac Safety Research Consortium (CSRC) and the Heart Rhythm Society. The conference will be held in Washington, DC, on April 14-15, 2011.
RXi Pharmaceuticals Corporation (Nasdaq:RXII), announced today that it will acquire Apthera, Inc., a private biotechnology company developing a pipeline of peptide-based immunotherapies for the adjuvant treatment of HER2-positive breast and other cancers. The acquisition provides RXi with a late stage product candidate, NeuVax, a peptide-based immunotherapy for low-to-intermediate HER2+ breast cancer, not eligible for Herceptin®, which is expected to enter Phase III clinical trials in the first half of 2012. The Company’s first RNAi product, RXI-109 for anti-scarring, remains on track for an investigational new drug application filing this year. In connection with the acquisition, Mark J. Ahn, PhD, currently a member of RXi’s Board of Directors, will succeed Noah D. Beerman as President and Chief Executive Officer of RXi and will lead the combined company, which will operate out of RXi's current headquarters.
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) today announced its plans to initiate a Phase IIb/III clinical trial of tasimelteon in patients with Major Depressive Disorder (MDD). The trial is expected to begin during the second half of 2011. Tasimelteon is currently being evaluated in Phase III clinical trials for the treatment of Non-24-Hour Sleep/Wake Disorder in blind individuals without light perception.
Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced new data from retrospective analyses that evaluated the relationship between variations at the IL28B gene and a patient’s response to treatment with telaprevir in combination with pegylated-interferon and ribavirin from two of its pivotal Phase 3 studies (ADVANCE and REALIZE) for a group of people who were tested for IL28B genotype. These analyses showed that people in these studies had substantial improvements in sustained viral response rates across all IL28B genotypes (CC, CT or TT) for those treated with telaprevir-based combination therapy compared to those treated with pegylated-interferon and ribavirin alone. Telaprevir is a medicine in development for the treatment of genotype 1 chronic hepatitis C. Safety and tolerability results were consistent across the Phase 3 studies of telaprevir.
Fero Industries, Inc. (OTCQB: FROI) (OTCBB: FROI) is pleased to confirm that it has delivered a third shipment of Sucanon® to Merck S.A. de C.V. for distribution in Mexico.