|NPS Shares Plunge 33% on Bowel Drug Deaths; Exelixis shares fall without FDA study commentary|
|By Staff and Wire Reports|
|Monday, 31 October 2011 19:14|
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a maker of drugs for rare disease, fell 33 percent after saying three people in a study for its experimental Gattex treatment for short bowel syndrome developed cancer and two died.
The patients who had cancer were at medical centers in Poland. They were the only ones among 566 participants who have received the drug to contract the disease, the Bedminster, New Jersey-based company said in a statement.
“The three cases of cancer have been reviewed by a safety review board comprised of independent experts and at this time no changes in study design or current monitoring of subjects in the trial have been requested,” the company said.
A 48-year-old patient died from cancer of the gastrointestinal tract after taking Gattex for 313 days. Lung cancer developed in a 64-year-old patient and a 74-year-old patient, both of whom had a history of smoking. The younger patient took the drug for 85 days and died from the cancer. The older patient was diagnosed after 535 days.
The study found Gattex helped patients reduce their reliance on intravenous fluids and extra nutrition. After a year of treatment, 91 percent of those given the drug needed less nutritional support. Three of the 37 patients receiving the medicine were able to stop supplemental nutrition entirely, according to a study presented at the American College of Gastroenterology’s annual meeting today.
NPS said it plans to file for U.S. Food and Drug Administration approval of the drug by the end of the year.
NPS dropped to $5.17 at the close in New York, the biggest single-day decline since May 3, 2006. NPS shares have fallen 17 percent in the past 12 months.
Exelixis Inc. (NASDAQ:EXEL) shares fell late Monday after the biotech drug developer said it will pursue a late-stage clinical trial for a prostate cancer treatment without supporting comments from the Food and Drug Administration.
Shares of Exelixis fell 32% to $5.25 in after-hours activity. Exelixis had originally pursued a special protocol assessment, or SPA, with the FDA for its prostate cancer treatment cabozantinib. An SPA is a declaration from the FDA that a firm's clinical-trial design will be capable of supporting a drug-efficacy claim before the trial begins.
Exelexis said it will begin the clinical trial for cabozantinib by the end of 2011 and will no longer pursue an SPA.
Affymetrix, Inc. (NASDAQ:AFFX) today announced that the company has entered into an agreement with the Broad Institute to chart the genomic changes involved in more than 20 types of cancer as part of the Broad’s work in The Cancer Genome Atlas (TCGA).
AquaLiv Technologies (OTCBB: AQLV) subsidiary, AquaLiv, Inc., discusses alternative medicine registration in Kenya for their NatuRx™ HIV/AIDS treatment.
AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging in vitro diagnostic company, reported that its Quality Management System has been certified to the requirements of both ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS) by BSI, one of the world′s leading certification bodies.
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics, announced that it will present data on its novel, first-in-class direct acting antiviral agents (DAA) against Hepatitis C Virus (HCV) at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2011.
Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, has been invited to present at the Lazard Capital Markets 8th Annual Healthcare Conference.
BioDrain Medical, Inc. (OTCBB: BIOR) (OTCQB: BIOR), producer of the FDA cleared STREAMWAY System for automated surgical fluid disposal, announced today that a prestigious Minneapolis-based hospital has commenced with the use of the STREAMWAY system in its operating rooms.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that the European Medicines Agency (EMA) has granted orphan drug designation for rindopepimut for the treatment of Glioblastoma (GB). GB is the most common and aggressive form of brain cancer.
Circadian Technologies Limited (ASX: CIR, OTCQX: CKDXY) announces that its 100% owned subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate clinical trials of VGX-100.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that company management will present at investor conferences during November 2011 to discuss the company’s business activities, financial outlook, and current news.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced favorable response and safety indications from a group of patients with advanced solid tumors (principally soft tissue sarcomas) in the Company’s ongoing Phase 1b/2 clinical trial with INNO-206, its tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial received three different dose levels of INNO-206 to determine its maximum tolerated dose.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new data that underscore the value of using PillCam SB for detecting and monitoring Crohn's disease.
iBio, Inc.(NYSE AMEX: IBIO) today announced notice of issuance from the United States Patent and Trademark Office for US Patent 8,058,511, entitled "System for Expression of Genes in Plants," that further extends iBio's patent coverage of viral vectors comprising its iBioLaunch™ platform.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has initiated two Phase 1 clinical trials of IPI-145, a potent, orally available inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma.
Mentor Capital, Inc. (OTC Markets: MNTR) announced that it has entered into a Letter of Intent to receive a current 30% ownership in AGI Biopharmaceuticals, Ltd., a European firm developing novel immuno-therapeutic cancer treatments.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) announced today that management will host a conference call at 2:15 PM ET today to discuss GATTEX® (teduglutide) data reported at the American College of Gastroenterology Annual Scientific Meeting.
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL™ (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.
PharmAthene, Inc. (NYSE Amex: PIP) announced today further development progress of its second generation rPA anthrax vaccine, SparVax™. The new vaccine is being developed to provide rapid manufacturing scale-up to respond to a national security emergency.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that data from four late-stage studies examining QNASL™ (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, will be presented at the 2011 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass., November 3-8, 2011.
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) today announced that preliminary results of a Phase II study evaluating the safety and efficacy of nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG) were reported at the 43rd Congress of the International Society of Paediatric Oncology (SIOP) conference being held in Auckland, New Zealand.