|Vical moves higher on updated clinical data. FDA accepts Aeterna Zetaris IND for bladder cancer drug|
|By BioMedReports.com Staff|
|Wednesday, 12 May 2010 19:56|
Below is a list of the companies that made news in the healthcare sector on Wednesday, May 12, 2010.
Vical Incorporated (Nasdaq:VICL) announced updated, positive data from the company's Phase II trial of high-dose Allovectin-7 in patients with metastatic melanoma.
The company said that data from the trial has indicated that patients who received high-dose Allovectin-7 had a median survival of 18.8 months, this compares to a median survival of 7-8 months for patients treated with chemotherapy.
The Phase 2 trial was a single-arm, open-label study in which 127 chemo-intolerant patients were treated with high-dose Allovectin-7. The median age of patients enrolled in the study was 60 years of age. The overall response rate for the 127 patients receiving the high-dose treatment was 11.8%, with 4 complete responders and 11 partial responders. The median duration of response was 13.8 months, ranging from a minimum of 6 months to a maximum of 66 months and is still ongoing.
Findings from the Phase 2 trial were incorporated into the design of a Phase 3 pivotal trial through a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7 as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. The company expects to complete patient follow-up and lock the Phase 3 clinical trial database in mid-2011.
Allovectin-7 is a novel gene-based immunotherapeutic with a unique mechanism of action that is fundamentally different from currently approved treatments, and has the potential to be the first new primary treatment approved for metastatic melanoma in nearly 20 years. Vical estimates that the worldwide market for Allovectin-7 as a treatment for metastatic melanoma could exceed $500 million annually, and applications for other types of cancer could further expand its total use.
Shares of Vical gained nearly 10% on the day, jumping 33 cents to $3.70.
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) today announced that the U.S. Food and Drug Administration has approved the Company's Investigational New Drug (IND) application for its doxorubicin targeted conjugate compound, AEZS-108, in luteinizing hormone releasing hormone (LHRH) receptor positive urothelial (bladder) cancer. Following this approval from the FDA, the Company expects to initiate a Phase 2 clinical trial in this indication in the second half of this year.
The study will be conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine with Gustavo Fernandez, M.D., Assistant Professor of Medicine, as the Principal Investigator, and will include up to 64 patients, male and female, with advanced LHRH-receptor positive urothelial (bladder) cancer. The study will be conducted in two parts; the first one will be a dose-finding part in up to 12 patients and then, the chosen dose will be studied for its effect on progression-free survival.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We are very pleased with the FDA's approval and excited about this Phase 2 trial in bladder cancer, since it will be our first with AEZS-108 in the United States, and the first one to include male patients. With this upcoming Phase 2 trial, as well as the current Phase 2 trial in advanced ovarian and endometrial cancer conducted in Europe, for which final results are expected before year-end, AEZS-108 has become a major component of our oncology portfolio."
Aeterna shares jumped 26 cents or 14% to $2.09.
In news from after the market close:
DARA BioSciences, Inc. (Nasdaq:DARA) announced after the bell today that the board of directors has determined to effect a reverse stock split at a ratio of 16:1 which will take effect at the start of trading on May 13, 2010. The main purpose of the reverse stock split is to enable the Company to regain compliance with the minimum $1.00 per share bid price requirement for continued listing of the Company's common stock on The NASDAQ Capital Market.
NexMed, Inc. (Nasdaq: NEXM) announced results from a pre-clinical study showing that Vitaros, the Company’s NexACT-based alprostadil product, significantly promoted healing of deep tissue wounds. Specifically, in a pig model, subjects with deep tissue wounds that were administered 200 mcgs of Vitaros healed four times faster than those receiving placebo over a 21-day period. This deep-seeded, wound healing pig model is widely regarded as the gold standard for pre-clinical testing of efficacy of wound-healing treatments. Vitaros is currently in late-stage development for the treatment of erectile dysfunction.
Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT), announced financial results for the three months ended March 31, 2010. "We are making final preparations to start a study to measure the potential effects of Intermezzo on highway driving ability the morning after dosing, and we currently estimate that we will resubmit the Intermezzo NDA in the late fourth quarter of 2010," stated Glenn A. Oclassen, Transcept President and Chief Executive Officer. "We remain committed to realizing the potential for Intermezzo to be the first prescription sleep aid approved in the United States for use as-needed for the treatment of insomnia at the time a patient awakens and has difficulty returning to sleep. We are pleased to have established our regulatory path forward as a result of our recent discussions with the FDA."
Transcept reported cash, cash equivalents and marketable securities of $83.08 million at March 31, 2010, which it believes will be sufficient to address the anticipated activities relating to the resubmission of the Intermezzo NDA.
In news from earlier in the day:
Capstone Therapeutics (Nasdaq:CAPS) announced today it has completed a limited analysis of a subset of data from the second of its two ongoing AZX100 Phase 2a clinical trials in keloid scarring. The clinical trial will continue to its planned 12-month endpoints. "We have again met our objectives for this preliminary analysis of our second keloid trial," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "Following a limited review by our independent statistician of the safety and quality of the dataset, we have been advised to continue the trial. The primary endpoint is the 12-month POSAS score; we expect to report data from this trial during 4Q2010."
Clinical Data, Inc. (NASDAQ: CLDA), announced today that its PGxHealth division is expanding its FAMILION family of genetic tests to include two new tests to diagnose heart diseases. With the launch of a test for Conduction Disease associated with Dilated Cardiomyopathy (CD-DCM) and a test for Short QT Syndrome, PGxHealth continues to lead the industry with the most comprehensive menu of genetic tests to diagnose or confirm familial heart diseases. The Company also announced the introduction of a significantly enhanced Brugada Syndrome (BrS) test, which now includes seven BrS-causative genes.
Hansen Medical, Inc. (NASDAQ:HNSN) announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration authorizing a clinical trial to investigate use of the Sensei X Robotic Catheter System and the Artisan Control Catheter for treatment of Atrial Fibrillation.
MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, today reported that MDRNA was chosen as a "Best and Brightest" technology leader by the MDB Capital Group based on the novelty, quality and industry impact of its innovative patent estate. The Company has a broad intellectual property estate of 17 issued or allowed patents, 41 pending U.S. patent applications, 6 pending PCT patent applications and 134 pending foreign patent applications that cover its RNAi technology. The MDRNA RNAi patent estate includes four key technologies needed to develop RNAi-based therapeutics: 1) siRNA constructs, 2) chemistry, 3) nucleic acid delivery and 4) gene targets. Selected from more than 1,600 technology companies, MDRNA was one of only fifty companies invited to showcase its IP story at the Bright Lights Conference in San Francisco, CA. J. Michael French, Chief Executive Officer and President of MDRNA, Inc., presented highlights of MDRNA's broad and comprehensive RNAi intellectual property estate at the Bright Lights Conference.
NeoStem, Inc. (NYSE Amex: NBS) today announced that its CEO will present at the NASDAQ MarketSite in Times Square, New York City on May 25, 2010, 1:00 pm EDT. NeoStem's CEO, Dr. Robin Smith will provide corporate updates and discuss important advances in the Company's business.
NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today reported financial results for the first quarter of 2010.
As of March 31, 2010, the company's cash, cash equivalents and short-term investments totaled $13.7 million, compared with $11.3 million at the end of 2009. The increase in cash was due to the receipt of $3.75 million in milestone payments from Galderma S.A. for the completion of both a formulation feasibility study and of an exploratory clinical study in adult acne. This revenue was reported in the fourth quarter of 2009 and received in the first quarter of 2010.
Pfizer Inc. (NYSE:PFE) and Ergonex Pharma GmbH announced today that they have entered into an agreement under which Pfizer will acquire terguride, which is in development as a potential treatment for Pulmonary Arterial Hypertension (PAH). Under the terms of the agreement, Pfizer will support the completion of the ongoing Phase 2 trial for terguride and will have exclusive worldwide rights excluding Japan to commercialize terguride for the treatment of PAH. Ergonex will be eligible to receive milestone payments and royalties on the sales of terguride for PAH.
Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today reported its financial results for the first quarter, ended March 31, 2010. These results are included in the Company’s Quarterly Report on Form 10-Q which has been filed with the SEC.
"Pro-Pharmaceuticals continues to make progress toward its goal to commercialize DAVANAT," said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "In the first quarter, we entered into an exclusive agreement with PROCAPS S.A. to market DAVANAT in Colombia as soon as we get regulatory approval in that country. We also plan to initiate a Phase lll colorectal cancer trial in the U.S. with DAVANAT and 5-FU this year."
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today provided an update on two antibody product candidates in its pipeline. "We are extremely pleased by the productivity of our antibody collaboration with sanofi-aventis, and the progress of the NGF and PCSK9 antibodies, in particular," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer. "The collaboration is not yet three years old, and we have been able to advance five antibodies into the clinic, highlighting the power of our VelocImmune® technology. Both REGN727 and REGN475 are being developed to address areas of high unmet medical need and represent important new additions to our clinical pipeline." Regeneron will provide additional corporate and clinical updates at its first Investor Day in New York City on July 15.
Revolutions Medical Corporation (OTCBB:RMCP), has signed an agreement of understanding for the setting up of a manufacturing facility in Brazil to produce the RevVac safety syringe for domestic and global markets and to facilitate distribution throughout South America.
Santa Monica Pharmaceutica Ltda has been formed and funded for the specific purpose of manufacturing and distribution of the RevMed proprietary RevVac safety syringe.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.
Sequenom, Inc. (Nasdaq:SQNM) today announced that it has entered into an agreement to issue and sell an aggregate of 12,435,000 shares of its common stock at $4.15 per share to certain investors. The aggregate gross proceeds of the private placement are expected to be approximately $51.6 million.
Skystar Bio-Pharmaceutical Company (NASDAQ:SKBI)a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, announced that it will commence product testing of two additional product dosage forms: oral solution and injectable soluble powder specifically formulated for Skystar's veterinary line of medicines.
SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of drugs to fight biowarfare pathogens, today announced that its Chief Executive Officer, Dr. Eric Rose, spoke before the House Subcommittee on Labor, Health and Human Services, and Education Appropriations today to discuss the biodefense industry's concerns that possible funding cuts to biodefense programs will hurt the development of medical countermeasures. In his remarks, Dr. Rose said that, despite the serious challenges facing lawmakers trying to balance the nation's budget, now is not the time to re-appropriate funding from programs supporting the industry such as BARDA or Project Bioshield. Limited funding will leave a void in the development of medical countermeasures needed to keep the United States safe from a bioterror attack.
Soligenix, Inc. (OTC Bulletin Board:SNGX.ob) a late-stage biopharmaceutical company, announced today that patient enrollment has been completed in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens.
SpectraScience, Inc. (OTC.BB:SCIE), announced today that it has been notified that two patents will be issued for its technology. Both patents are for an "optical biopsy system and methods for tissue diagnosis." The patents will be issued by the Japanese Patent office and the European Patent office.
American Bio Medica Corporation (Pink Sheets:ABMC) announced today its financial results for the three months ended March 31, 2010.
Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free drug delivery systems, today reported financial results for the quarter ended March 31, 2010.
BioPharm Asia, Inc. (OTCBB: BFAR), a producer, distributor and retailer of medical products in China, today reported its financial results for the full year ended December 31, 2009.
CEL-SCI Corporation (NYSE AMEX: CVM), a late stage cancer company, announced today that Geert Kersten, Chief Executive Officer, will be presenting an overview of the upcoming Phase III clinical trial with the Company's cancer immunotherapy product Multikine® at the Rodman & Renshaw Annual Global Healthcare Conference.
China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today provided an update on the commercialization plan for the 13 new products.
CorMedix Inc. (NYSE Amex: CRMD.U), a pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of cardiorenal disease, today announced its results for the three months ended March 31, 2010.
CryoPort, Inc. (OTCBB: CYRX) today announced that Larry Stambaugh, Chairman and Chief Executive Officer, will be presenting at the Source Capital Group Small Cap Virtual Conference, scheduled for May 18-19, 2010.
GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB) today reported its financial results for the first fiscal quarter ended April 4, 2010.
HemaCare Corporation (OTCBB: HEMA) announced today first quarter 2010 results, with revenue of $7.85 million and a net loss of $204,000, or $0.02/share, compared to first quarter 2009 revenue of $9.71 million and net income of $69,000, or $0.01/share.
Lannett Company, Inc. (NYSE AMEX: LCI) today reported financial results for the fiscal 2010 third quarter and nine months ended March 31, 2010.
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today announced the completion of the updating and launch of its website.
NanoViricides, Inc. (OTC BB: NNVC.OB) announced today that it has raised $5,000,000, drawing down on its previously announced universal registered shelf "Form S-3" offering. The registered shelf offering became effective on April 29, 2010.
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative biomedical surgical oncology products, today announced that its Vice President, Finance and Chief Financial Officer, Brent Larson, will present on Tuesday, May 18, 2010 at 11:30AM BST, in the Spencer Suite, during the Rodman & Renshaw Annual Global Investment Conference to be held at the Grosvenor House Hotel in London, UK.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that the Company has funded 15 Stephanie Carroll scholarships in honor of Nurses Week.
Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today reported its financial results for the first quarter, ended March 31, 2010.
pSivida Corp. (NASDAQ: PSDV), a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its third quarter and nine months ended March 31, 2010.
PURE Bioscience (NASDAQ: PURE) today announced that President and CEO Michael L. Krall will be presenting at the Source Capital Group Small Cap Virtual Conference, scheduled for May 18-19, 2010.
Rite Aid (NYSE: RAD) announced today that The Rite Aid Foundation is donating water, food, cleaning and first aid supplies to the American Red Cross Disaster Relief Fund to help the victims, families and communities affected by the recent flooding in Alabama, Kentucky and Tennessee.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will host an Analyst Meeting the morning of Wednesday, May 26, 2010, starting at 9:00 a.m. (EDT), at the Mandarin Oriental New York, 80 Columbus Circle at 60th Street, in New York City.
Virtual Closet, Inc. (OTCBB:VIRZ) today announced that effective on May 10, 2010 the Company's acquired Dong Ke Pharmaceutical, Inc.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Jonathan Lewis, MD, PhD, Chief Executive Officer, will present at the Rodman & Renshaw Annual Global Investment Conference on Monday, May 17, 2010 at 9:50 am ET (14h50 BST) at The Grosvenor House Hotel in London, UK. Dr. Lewis will provide an overview of the Company and its clinical development programs.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.