|Targacept Announces Negative Top-Line Results from Phase 2b Trial of TC-5619; Myriad Presents Positive Clinical Data on HRD Test|
|By Staff and Wire Reports|
|Monday, 16 December 2013 21:16|
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, announced top-line results from a Phase 2b clinical trial of TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia. In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the Scale for the Assessment of Negative Symptoms (SANS) after 24 weeks versus placebo. In addition, TC-5619 did not demonstrate improvement on the key secondary measures of cognitive function. TC-5619 exhibited a benign safety and tolerability profile in the study.
“The development of new and innovative treatments for patients suffering from central nervous system disorders is challenging, and the results of this study highlight the risks inherent in trying to address the unmet medical needs that remain in schizophrenia,” said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. “While the results are disappointing, we believe the study was well conducted and provides a robust dataset upon which we have based our decision to not pursue further development of TC-5619 as a treatment for either schizophrenia or Alzheimer's disease. We will focus our efforts on our other ongoing Phase 2b programs, TC-5214 for overactive bladder and TC-1734 for Alzheimer's disease, continue forward with the planned development of TC-6499 for diabetic gastroparesis, and maintain our disciplined approach to executing our business plan which seeks to provide new medicines to improve patients' lives.”
Myriad Genetics, Inc. (Nasdaq: MYGN) presented clinical data at the 2013 San Antonio Breast Cancer Symposium that showed the Myriad's HRD (homologous recombination deficiency) test was significantly associated with cisplatin response in patients with triple negative breast cancer.
In this research study, Myriad's HRD test provided optimal prediction of platinum response in patients with triple negative disease (p=0.0003). The HRD score predicted all of the patients that experienced a complete response after pre-surgical treatment with platinum with a sensitivity of 100 percent. Furthermore, these results showed that the HRD score not only predicted drug response in triple negative patients but the HRD score also was generalizable across all breast cancer subtypes.
"Often tumors with high rates of double-strand DNA repair deficiency are especially difficult to treat," said Jerry Lanchbury, Ph.D., Chief Scientific Officer of Myriad Genetics. "It is difficult to know or assess the status of all DNA repair mechanisms, so the HRD test measures the effect by assessing the amount of DNA damage. Our data demonstrate that Myriad's HRD test has the capacity to precisely target DNA damaging therapy to the patients who are most likely to respond. The HRD test has the potential to support the targeted use of PARPs and other drugs in tumors that exhibit DNA repair scars."
This is the second research study to show that Myriad's HRD test predicts drug response to platinum therapy in triple-negative breast cancer patients. In a prior study, 70 percent of patients with an HRD score ≥10 responded to the carboplatin-based treatment, compared to only 20 percent of patients with an HRD score < 10 (p=0.0001). Using the HRD test instead of BRCA status identified more than three times as many patients as likely responders.
Myriad has announced two commercial collaborations to further develop the HRD test. In March, the Company announced it is conducting HRD testing on patients enrolled in PharmaMar's Phase 2 study of PM1183. In Nov. 2013, Myriad announced a collaboration with BioMarin that will use the HRD test to identify tumor types that may be sensitive to BioMarin's investigational product candidate, BMN-673. The Company also has two other undisclosed collaborations to evaluate HRD as a companion diagnostic.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary non-stimulant drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today highly statistically significant positive results from a Phase IIb clinical trial with MG01CI in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PI-ADHD).
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the appointment of current President, John F. Thero, as President and Chief Executive Officer of the company, effective January 1, 2014. Mr. Thero will also be appointed to the Board of Directors, effective January 1, 2014.
Apricus Biosciences, Inc. (Nasdaq:APRI), announced today that it has expanded its exclusive license agreement with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies, for the commercialization of Vitaros®, indicated for the treatment of patients with erectile dysfunction. In addition to the in-place collaboration in Germany, this expanded agreement now includes Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the Netherlands, Norway, Sweden and Switzerland.
BioMed Realty Trust, Inc. (NYSE: BMR) today announced that its board of directors has declared a fourth quarter 2013 dividend of $0.25 per share of common stock, representing a 6.4% increase over the company's third quarter 2013 dividend of $0.235 per share.
Cambrex Corporation (NYSE: CBM) announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex's active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa.
The ClearPoint® Neuro Intervention System developed by MRI Interventions, Inc. (OTCQB:MRIC) was featured December 10 in a television segment and article reported by the ABC-TV affiliate in Boston (WCVB-TV).
EHouse Global, Inc. (OTCBB:EHOS), would like to announce a new article was posted to www.ScienceDaily.com on October 21, 2013, which unveils a recent study published by The Journal of Pediatrics (http://www.jpeds.com) that extensively explores the link between low levels of vitamin D and anemia in children.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced preclinical data suggesting the company's folate receptor-targeted SMDCs may provide a possible new treatment alternative for folate receptor expressing triple negative breast cancer (TNBC) patients.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, assisted living, home health, hospice and urgent care companies, today announced that its Board of Directors has declared a quarterly cash dividend of $0.07 per share of Ensign common stock, payable on or before January 31, 2014 to shareholders of record as of December 31, 2013.
Gevo, Inc. (Nasdaq:GEVO), a leading renewable chemicals and next-generation biofuels company, announced the closing of its previously announced public offering of 18,525,000 common stock units, at a price to the public of $1.35 per unit.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announced that the company will accelerate its experimental program for a new intranasal influenza vaccine combination following a media briefing by the Centers for Disease Control (CDC) urging Americans, especially young children and the elderly, to get vaccinated for the emerging flu season immediately (CDC, December 12, 2013), coincidental with National Influenza Vaccination Week.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced a strategic partnership with athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health records (EHR), practice management, and care coordination. athenahealth will integrate Merge's iConnect Network with its national cloud-based platform, enabling athenahealth clients to receive and view exam results, diagnostic quality images and other critical patient information within the athenaClinicals® EHR workflow.
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) today announced the results of the annual re-ranking of the NASDAQ Biotechnology Index (Nasdaq:NBI), which will become effective prior to market open on Monday, December 23, 2013. The following 21 securities will be added to the Index: AcelRx Pharmaceuticals, Inc. (Nasdaq:ACRX), Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX), bluebird bio, Inc. (Nasdaq:BLUE), ChemoCentryx, Inc. (Nasdaq:CCXI), Cempra, Inc. (Nasdaq:CEMP), Chimerix, Inc. (Nasdaq:CMRX), Epizyme, Inc. (Nasdaq:EPZM), Esperion Therapeutics, Inc. (Nasdaq:ESPR), Horizon Pharma, Inc. (Nasdaq:HZNP), Cellular Dynamics International, Inc. (Nasdaq:ICEL), Insys Therapeutics, Inc. (Nasdaq:INSY), KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH), OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), Onconova Therapeutics, Inc. (Nasdaq:ONTX), Prothena Corporation plc (Nasdaq:PRTA), PTC Therapeutics, Inc. (Nasdaq:PTCT), Portola Pharmaceuticals, Inc. (Nasdaq:PTLA), Regulus Therapeutics Inc. (Nasdaq:RGLS), Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) and Verastem, Inc. (Nasdaq:VSTM).
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, today announced completion of enrollment in its PreSERVE AMI study. PreSERVE AMI is a randomized, double-blind placebo-controlled Phase 2 clinical trial testing NeoStem's lead product candidate, AMR-001, an autologous adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI).
RadNet, Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 251 owned and operated outpatient imaging centers, today announced that it completed an initial analysis of changes for 2014 in the Medicare Physician Fee Schedule and the Hospital Outpatient Prospective Payment System (HOPPS) rates as determined by the Final Rule as released by the Centers for Medicare & Medicaid Services (CMS) on November 27th.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced today that it has received a US$5M milestone from Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY). In addition, Tekmira is entitled to ongoing royalties related to the product upon commercialization.
Veracyte, Inc. (Nasdaq: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced that Cigna, one of the nation's leading providers of health insurance, has issued a positive coverage policy for the company's Afirma Gene Expression Classifier (GEC).
Clinton Group, Inc., one of the largest owners of Xenoport, Inc. (NASDAQ: XNPT), sent a letter to the Lead Director of Xenoport, Dr. John G. Freund, following a recent meeting with Dr. Freund and Dennis Fenton, another independent director of Xenoport.