|AVI BioPharma reports positive muscle drug data. Arena announces advisory committee review date. BSD Medical shows promise with pancreatic cancer treatment|
|By BioMedReports.com Staff|
|Wednesday, 02 June 2010 19:26|
Below is a list of the companies that made news in the healthcare sector on Wednesday, June 2, 2010.
AVI BioPharma, Inc. (NASDAQ:AVII), rose more than 10% today after the developer of RNA-based drugs, announced topline biopsy data from Study 28, the ongoing Phase 1b/2 clinical trial of AVI-4658, AVI's lead drug candidate being developed as a systemically administered treatment for a substantial subgroup of patients with Duchenne muscular dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. Topline biopsy data from the study demonstrated the first ever reported generation of new dystrophin-positive muscle fibers of more than 50% of normal in a patient with DMD following systemic administration of a drug. All patients in the two highest dose cohorts of the study demonstrated generation of new dystrophin-positive muscle fibers, although treatment responses varied across and within treatment groups. Generation of functional dystrophin is considered critical for successful treatment of DMD, and AVI intends further clinical evaluation of AVI-4658 to help optimize a dosing regimen to achieve more consistent improvements among patients.
"These results are very encouraging. The muscle cells of the patients at the higher levels had clear qualitative and quantitative changes in their dystrophin expression and this was not associated with any sign of inflammation or immune response against dystrophin-positive fibers. To look at the muscle biopsies of these treated patients under the microscope, and appreciate the new production of dystrophin compared to the pre-treated muscles, reveals a very different picture from that typically observed in DMD patients," stated Prof. Francesco Muntoni, Professor of Pediatric Neurology and Head of the Dubowitz Neuromuscular Centre at the UCL Institute of Child Health, London, England and the trial's lead investigator. "This trial demonstrates the potential of a systemically administered drug to induce a substantial novel dystrophin protein expression in multiple patients with DMD at levels that may produce a clinically meaningful effect on the course of the disease. Based on these results and on how the patients tolerated the study drug, I believe that AVI-4658 has the potential to become a disease modifying drug in the treatment of DMD."
Shares of AVI moved 14 cents higher, closing the day at $1.53.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that the US Food and Drug Administration has notified the company of the tentative scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application. Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, and it is intended for overweight patients with at least one weight-related co-morbid condition and obese patients.
"We are focused on obtaining the FDA's approval of lorcaserin, and have been preparing for this anticipated advisory committee meeting," said Jack Lief, Arena's President and Chief Executive Officer. "With its unique combination of safety, tolerability and efficacy, we believe that lorcaserin, if approved, has the potential to serve as first-line therapy to help patients achieve sustainable weight loss in a well-tolerated manner."
Arena submitted the lorcaserin NDA on December 22, 2009, and the FDA assigned a PDUFA date, the target date for the agency to complete its review of the application, of October 22, 2010.
BSD Medical Corporation (NASDAQ: BSDM) today reported impressive results from a clinical study on the use of hyperthermia, delivered using the BSD-2000 Hyperthermia System, to treat pancreatic cancer. Dr. S. Maluta, University Hospital of Verona, Italy, reported the results of a randomized Phase II study of 74 patients with advanced pancreatic cancer: "Hyperthermia combined with radiochemotherapy in unresectable locally or recurrent advanced pancreatic cancer, a Phase II perspective study."Dr. Maluta reported that the recurrent and metastatic pancreatic patients who were treated with hyperthermia combined with radiochemotherapy had a median survival of 14 months, as compared to a median survival of only 5 months for those treated with radiochemotherapy alone. The one-year survival was increased by 3 months for all patients who were treated with hyperthermia, as compared to patients who did not receive hyperthermia treatment. The treatment was well tolerated with no increase in toxicity from the addition of hyperthermia. Dr. Maluta reported that these results support initiation of a Phase III study. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy.
BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE:BDX), announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAX System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.
BioMed Realty Trust, Inc. (NYSE:BMR) today announced the promotion of Greg Lubushkin to Chief Financial Officer. Mr. Lubushkin has served as the company's Vice President, Chief Accounting Officer since joining BioMed in April 2007.
CANTEL MEDICAL CORP. (NYSE:CMN), through its Mar Cor Purification subsidiary, has continued the expansion of its water purification and filtration segment by purchasing Texas-based Purity Water Company of San Antonio, Inc. Purity provides water treatment equipment and services for laboratory, industrial, medical, pharmaceutical and semiconductor customers in Texas and neighboring states. The acquired business had pre-acquisition revenues of approximately $3.0 million. This cash deal is expected to be slightly accretive to Cantel's earnings per share in the first year.
Cypress Bioscience, Inc. (NASDAQ:CYPB) announced today that Palmetto GBA, administrator for Medicare Part B in California, has issued a positive coverage determination for the company's Avise PG testing service. Avise PG is a test which aids doctors in therapy decisions regarding methotrexate, one of the most widely prescribed drugs for rheumatoid arthritis."This decision to include Avise PG in the Medicare reimbursement guidelines was based upon a demonstration of the clinical validity and utility of the test, providing physicians with insight into their patient's metabolism of methotrexate," said Mike Gendreau, Chief Medical Officer at Cypress.
Discovery Laboratories, Inc. (Nasdaq:DSCO), announced today that The Nasdaq Stock Market, LLC has approved Discovery Labs' application to transfer its stock listing from The NASDAQ Global Market to The NASDAQ Capital Market. The transfer will be effective at the opening of the market on June 4, 2010. The Company's common stock will continue to be traded under the symbol "DSCO" and the transfer will have no impact on the ability of investors to trade the stock. The NASDAQ Capital Market is a continuous trading market that operates in the same manner as The NASDAQ Global Market. All companies listed on The NASDAQ Capital Market must meet certain financial requirements and adhere to Nasdaq's corporate governance standards. On December 2, 2009, the Company received a delisting notification from The NASDAQ Global Market indicating that the Company's common stock had failed to close above $1.00 per share for more than 30 consecutive trading days and, as a result, the Company was not in compliance with the Minimum Bid Price Rule.
EntreMed, Inc. (Nasdaq:ENMD), moved higher today after the company announced the publication of preclinical results for its clinical-stage Aurora A/angiogenic kinase inhibitor, ENMD-2076, in human colorectal cancer xenograft models. ENMD-2076, EntreMed's lead oncology drug candidate and currently in a multi-center Phase 2 study in ovarian cancer patients, demonstrated robust antitumor activity against murine xenograft models of human colorectal cancer (CRC) established from both cell lines and primary human samples.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) jumped nearly 10% today after the company, as reported earlier today and forcasted yesterday by BioMedReports, reported encouraging results from its experimental therapeutic brain cancer vaccine. The company said that median overall survival had not yet been reached at the 26.4 months analysis point, with 12 out of 16 patients alive and that seven patients continued to live with no disease progression.
Shares of ImmunoCellular shares moved up 14 cents or 9.15% to $1.67.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report on the presentation of new positive data at a high-level symposium and panel discussion held at the Annual Meeting of the American Urological Association in San Francisco.The new data concerned outcome analyses of single-injection NX-1207 in 51 patients. Subjects in the NX-1207 2.5 mg cohort had mean improvements in their BPH symptoms that reached statistical significance. According to the report, "NX-1207 is an office-based procedure involving only a few minutes to administer associated with minimal discomfort and no catheter requirement", and "results indicate statistically significant symptomatic improvement and a very acceptable safety profile".
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today it has entered into a strategic partnership agreement with Perceptive Imagineering LLC to expand the commercialization of RPC's Onko-Sure IVD cancer test in Latin America.
Under the terms of the agreement, Perceptive Imagineering will represent RPC and conduct product registration, marketing, sales and support for the licensing and distribution of Onko-Sure as a cancer screen in Central America, South America, Mexico and the Caribbean. Beginning with Colombia, Perceptive will seek government approval and work with regional and government leaders to promote brand and product awareness for Onko-Sure as a general cancer screen. Perceptive will also develop an Onko-Sure branded website adapted for the Latin American culture.
According to Dr. Nancy Alvarez, President of Perceptive Imagineering, "It is our belief that if RPC and Perceptive can offer a non-invasive test that has the potential of detecting cancer in early stages, then the general Colombian population will be more proactive in seeking medical treatment for the deadly disease of cancer. One of the largest issues in Colombia and throughout South America in general, is a lack of urgency in seeking medical attention for health conditions. Many times people will only seek medical attention when they've had symptoms for extended periods of time. For people with cancer, this means the disease may be in stage three or four when the probability of curing the disease has been severely compromised. With the ability of potentially detecting cancer in earlier stages with Onko-Sure we hope to make proactive cancer testing a more culturally accepted practice. Our focus is to launch a full cancer screening awareness campaign in partnership with Radient Pharmaceuticals."
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), announced that the Company has acquired an exclusive worldwide license to intellectual property related to the potential treatment of Huntington's Disease from the Weizmann Institute of Science in Israel and Niigata University in Japan. In addition, Raptor has added Professor Lawrence Steinman, M.D., an inventor on the Weizmann patent, to its Advisory Board.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that is has begun to enroll patients in the first study in its Phase III clinical program to evaluate the efficacy and safety of rifamycin SV MMX for the treatment of patients with travelers’ diarrhea.
"The Ministries of Health in Mexico and Guatemala have approved our clinical trial applications for the Phase III study with rifamycin SV MMX, and we are beginning to enroll patients at clinical sites in these countries," said E. David Ballard, M.D., senior vice president, clinical research and medical affairs of Santarus. "Our plan for patient enrollment is to coincide with the peak summer travel season."
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that it has received written, scientific advice from the European Medicines Agency (EMA) on the Company's proposed plans for further development of voreloxin in acute myeloid leukemia (AML), including the Company's plans for a pivotal trial in patients with first relapsed or primary refractory AML. The EMA's written advice, similar to guidance previously received from the U.S. Food and Drug Administration (FDA) in February following formal End-of-Phase 2 meetings, is consistent with and supportive of Sunesis' proposed plans, and provides development clarity toward a potential regulatory submission for marketing approval. The EMA issued its advice following its established consultative review process.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced U.S. Food and Drug Administration approval and commercial launch of its generic version of Galderma’s product, Differin (adapalene 0.1%) Gel, which is indicated for the treatment of acne.
The brand product had annual sales of approximately $91 million in the United States, based on IMS sales data.
VCA Antech, Inc. (Nasdaq:WOOF), a leading animal healthcare company in the United States, and PET DRx Corporation (Nasdaq:VETS), a provider of veterinary primary care and specialized services to companion animals, today announced the signing of definitive transaction agreements pursuant to which PET DRx will be acquired by VCA Antech. According to the terms of the agreement, VCA Antech will acquire PET DRx for $41.25 million in cash. After the payment of debt and other adjustments, the Company expects the purchase price to be in the range of $0.34 to $0.36 per common share.
ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced the initiation of the second part of a Phase 2 clinical trial with PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection. ZymoGenetics is developing the investigational compound PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company (NYSE:BMY).
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it will present at the Ninth Annual Needham Healthcare Conference on Wednesday, June 9, 2010 at 3:20 p.m. Eastern Time at The New York Palace Hotel in New York City.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced today the company is sponsoring five poster presentations during the joint 24th Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the 15th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), being held in San Antonio, TX from June 2-5, 2010.
China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that its wholly owned subsidiaries, Harbin Tian Di Ren Medical Science and Technology Company, Harbin First Bio-Engineering Company Limited, Heilongjiang Tianlong Pharmaceutical, Inc. and Heilongjiang Haina Pharmaceutical, Inc. have been recognized as Heilongjiang's Model Companies by the Heilongjiang Provincial Government.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at the Jeffries 2010 Global Life Sciences Conference, which is being held June 8-11, at the Grand Hyatt in New York.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of preventive and therapeutic vaccines against cancers and infectious diseases, announced today that president and CEO, Dr. J. Joseph Kim will present a corporate update on its DNA vaccines for influenza, HIV and cancer and its vaccine delivery technology at the following investor conferences: Noble Financial Sixth Annual Equity Conference, June 7th, 2010 Hollywood, FL Presentation: June 7th, 2010, 9:00 a.m. ET.
IntriCon Corporation (NASDAQ:IIN), a designer, developer, manufacturer and distributor of body-worn medical and electronics devices, today announced that it has completed the previously announced divestiture of its non-core electronics business, Anaheim, Calif.-based RTI Electronics, Inc.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that President and Chief Executive Officer John L. Higgins will present at the Jefferies Global Life Sciences Conference on Wednesday, June 9, 2010, at 4:30 p.m. Eastern time (1:30 p.m. Pacific).
MDRNA, Inc. (NASDAQ: MRNA), a leading RNA-based drug discovery and development company, today announced that it will be presenting at the 9th Annual Needham Healthcare Conference held at the New York Palace Hotel in New York City.J. Michael French, MDRNA's President and Chief Executive Officer, will provide a business update and overview of the Company on Wednesday, June 9, 2010 at 2:40 p.m. (Eastern Time).
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Axcan Pharma Inc. (Axcan) has extended its use of Medidata Rave® as its electronic data capture (EDC) and clinical data management (CDM) system, bringing study build and execution into the organization through Medidata training and mentoring.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Jefferies 2010 Global Life Sciences Conference and also at the 9th Annual Needham Healthcare Conference, both in New York.
Oramed Pharmaceuticals Inc. (OTCBB: ORMP), a developer of oral drug delivery systems, announced today that its subsidiary Oramed Ltd. entered into a joint venture agreement with Laser Detect Systems Ltd., an Israeli company listed on the Tel Aviv Stock Exchange, for the establishment of a new company to be called Entera Bio Ltd.
Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines in China, today announced it will host a conference call at 9:00 a.m. Eastern Time on Tuesday, June 8, 2010, to discuss financial results for the second quarter of its fiscal year 2010, ended April 30, 2010.
Repligen Corporation (Nasdaq: RGEN) announced today that it will disclose its financial results for the fourth quarter and fiscal year 2010, on Wednesday, June 9th, 2010, before the market opens.
Response Genetics Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today that it will present data from eight studies investigating the clinical utility of its proprietary technology, RGI-1, during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from June 4 to June 8, 2010.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today announced that the Company's President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the Jefferies 2010 Global Life Sciences Conference on Thursday, June 10, 2010 at 3:00 p.m. ET in New York City.
Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that Clay B. Siegall, Ph.D., President and Chief Executive Officer, will present a company overview at three upcoming investor conferences.
Senomyx, Inc. (NASDAQ: SNMX), a leading company focused on using proprietary taste receptor technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that John Poyhonen, the Company's President and Chief Operating Officer, and Tony Rogers, Vice President and Chief Financial Officer, will present a corporate overview on Wednesday, June 9, 2010 at 9:20 a.m. Eastern Time (6:20 a.m. Pacific Time) during the 9th Annual Needham Healthcare Conference.
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) today announced that Richard W. Pascoe, Somaxon's president and chief executive officer, will present at the Jefferies 2010 Global Life Sciences Conference at The Grand Hyatt Hotel in New York City on Thursday, June 10th at 11:30 a.m. Eastern Time.
Wellstar International Inc. (OTCBB:WLSI) announces that the authors of the Duke University Study results have received the second round of questions and clarifications for the publication in the "Advances of Skin and Wound Care" medical journal.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it will present at the following investor conferences on Wednesday June 9, 2010: 9th Annual Needham Healthcare Conference New York, NY10:40 a.m. ET.
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