|Oncothyreon resumes cancer vaccine trial. NMT Medical shares plummet after stroke therapy trial fails. After the bell Adolor's pain drug study fails mid-stage trial|
|By BioMedReports.com Staff|
|Thursday, 17 June 2010 19:10|
Below is a list of the companies that made news in the healthcare sector on Thursday, June 17, 2010.
Adolor Corporation (NasdaqGM: ADLR) after the bell announced results from a Phase 2a clinical trial of ADL5859 and ADL5747 in patients with osteoarthritis (OA). The trial was a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the safety, tolerability and clinical activity of ADL5859 and ADL5747 in patients with OA of the knee. The study enrolled over 400 patients aged 18 and older in four arms. In the three drug arms, patients were given either ADL5859 (150 mg), ADL5747 (150 mg) or oxycodone CR (20 mg) twice daily for two weeks. The primary efficacy endpoint was reduction in pain score as measured by the numeric pain rating scale (NPRS), an 11-point categorical scale, for week two of the study. To be eligible for inclusion in the trial, patients must have reported an average weekly pain score of at least 4.0 on the NPRS for the index knee during the baseline week before randomization.
Top-line results of the study showed a high placebo response, with neither oxycodone CR nor ADL5859 nor ADL5747 demonstrating a statistically-significant improvement over placebo. Both ADL5859 and ADL5747 were well tolerated when given at 150 milligrams twice daily.
"We obviously are disappointed with the results of this study," said Eliseo O. Salinas, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Adolor. "The extent of placebo response was surprising, but unfortunately not unusual in osteoarthritis studies. Pfizer and we expect to fully assess this data set over the coming weeks and make a determination as to whether additional testing of the delta compounds in chronic inflammatory pain indications is warranted. Our Phase 2a clinical study of ADL5747 in post-herpetic neuralgia continues, with top-line data expected in the first quarter of 2011."
Shares of Adolor dropped 18% after the bell, falling 27 cents to $1.23.
Alkermes, Inc. (NASDAQ: ALKS) after the market close announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company’s supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence. Notification of this potential advisory committee meeting follows a designation in May 2010 by the FDA of priority review of the VIVITROL sNDA, a designation that accelerates the FDA’s target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.
In news from earlier in the day:
Oncothyreon Inc. (Nasdaq:ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., are resuming the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine) in non-small cell lung cancer (NSCLC), including the Phase 3 START and INSPIRE trials. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees. The announcement follows a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed.
"Merck Serono worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program," commented Dr. Bernhard Kirschbaum, Head of Global Research and Development of the Merck Serono division, Merck KGaA. "We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries."
The Phase 3 STRIDE trial in advanced breast cancer remains on clinical hold by the FDA. Merck Serono announced that it will continue to work closely with the health authorities, including the FDA, to decide the next steps for this trial.
"Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients," said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. "We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients."
"The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients," said Dr. Frances Shepherd, Director of the Medical Oncology Princess Margaret Hospital in Toronto, Ontario, Canada, and Coordinating Investigator of the START trial.
Merck Serono temporarily suspended its global clinical program for BLP25 liposome vaccine in all recruiting studies worldwide following the clinical hold put in place by the FDA in March 2010. The clinical hold followed a suspected unexpected serious adverse reaction of encephalitis, observed in a patient enrolled in an exploratory Phase 2 trial of BLP25 liposome vaccine in patients with multiple myeloma. To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures.
Shares of Oncothyreon rallied more than 11% on the news, jumping 42 cents to $4.03.
NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced that it has received preliminary results for CLOSURE I, its patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the U.S. CLOSURE I is the first fully enrolled, randomized clinical trial to evaluate the effectiveness of PFO treatment in preventing recurrent strokes and TIAs. Analysis of the data for CLOSURE I commenced in April 2010.
The preliminary results of CLOSURE I data analysis indicate that the trial did not achieve its primary endpoint: to demonstrate that treatment by device closure with the STARFlex® technology is superior to the current best medical therapy for preventing recurrent strokes and TIAs. However, the preliminary results indicate that closure with STARFlex® provided a small, but not statistically significant, benefit over current best medical therapy.
The trial’s preliminary results indicate that the safety profile of the STARFlex® device had a low rate of complications, similar to that of current best medical therapy. In addition, there was a very low rate of thrombus formation. Closure rates in the trial were 86.5%, which is consistent with NMT’s previously reported results for the STARFlex® implant, and in line with other transcatheter closure devices.
NMT President and Chief Executive Officer Frank Martin said, "Although we are disappointed that we did not meet the primary endpoint, we are currently in discussions with the U.S. Food and Drug Administration (FDA) to evaluate our possible next steps relating to the stroke/TIA indication. In addition, we are working with our clinical investigators, contract research organization, and the CLOSURE I Executive Committee to analyze the full trial data set to help us better understand and evaluate our clinical and regulatory options. We will update our stakeholders on our strategy going forward once we have completed some additional discussions with all parties. It is anticipated that full data results will be discussed at the American Heart Association meeting in November 2010."
"The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," Martin said. "NMT remains committed to addressing structural heart disease through minimally invasive, catheter-based procedures. We are continuing to develop the next generation of bioabsorbable implants, including our BioTREK™ device. In addition, we should note that the results of CLOSURE I have no impact on the status of our current FDA and CE Mark approvals for ventricular septal defect (VSD) and atrial level shunt patients."
Shares of NMT Medical plummeted more than 78% on the news, dropping $2.20 to 56 cents.
Allos Therapeutics, Inc. (Nasdaq:ALTH) announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of cutaneous T-cell lymphoma (CTCL). The Company is currently investigating pralatrexate in a Phase 1 clinical study in patients with relapsed or refractory CTCL. In addition, the Company plans to conduct a Phase 3 clinical study comparing FOLOTYN in combination with systemic bexarotene versus systemic bexarotene alone in patients with CTCL who are refractory to at least one prior systemic therapy. Prior to initiation of the Phase 3 study, the Company will conduct a Phase 1 study to determine the maximum tolerated dose of the combination, which the Company plans to initiate in 2010. The EC previously granted orphan designations for pralatrexate for the treatment of patients with peripheral T-cell lymphoma (PTCL) and non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (NYS: GSK) today announced the presentation of additional results from BLISS-52, one of two pivotal Phase 3 trials of BENLYSTA® (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The additional data will be presented in Rome at the 2010 Congress of the European League against Rheumatism (EULAR) on Saturday, June 19.
"The BLISS-52 Phase 3 results presented at EULAR demonstrate that the efficacy of treatment in this study with belimumab plus standard of care was superior to that of placebo plus standard of care," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Belimumab has met the primary endpoint in both of its pivotal Phase 3 trials. Earlier this month, we and GSK submitted marketing applications for belimumab in the United States and Europe. We now look forward to the consideration and conclusions of regulatory authorities."
Life Technologies Corporation (NASDAQ:LIFE), a provider of innovative life science solutions, today announced activities and product launches in concert with the International Society for Stem Cell Research (ISSCR) 8th Annual Meeting that highlight the company’s offerings of complete end-to-end solutions for stem cell research. Stem cell research has been shown to be a critical component of regenerative medicine; a basis for identifying drug targets and drug screening; and an important step in the development of therapies to treat a variety of diseases.
Life Technologies’ portfolio of workflow solutions addresses the entire stem cell continuum, including the isolation, expansion, differentiation and characterization of cells. The company’s innovative stem cell reagents offered under its Invitrogen brand coupled with its industry-leading instrument and workflow-based systems under its Applied Biosystems brand enable the acceleration of stem cell research breakthroughs.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Hydroxyzine Hydrochloride Tablets 10 mg, 25 mg and 50 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Pliva's Hydroxyzine Hydrochloride Tablets, a treatment for nervousness and tension.
Hydroxyzine Hydrochloride Tablets had U.S. sales of approximately $55 million for the 12 months ending March 31, 2010, according to IMS Health.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced today that they have established a worldwide collaboration with Boehringer Ingelheim to research and develop small molecule GPR119 agonists for the treatment of Type II diabetes and other indications. The companies will work jointly to identify and advance candidates into pre-clinical development. Boehringer Ingelheim is responsible for the global development and commercialization of potential GPR119 agonist products.
Under the terms of the collaboration agreement, Neurocrine Biosciences will receive a $10 million upfront payment, research funding to support discovery efforts and is eligible to receive up to $225 million in milestone payments based on the achievement of development, regulatory and commercial goals as well as royalty payments on any future product sales. Further financial details were not disclosed.
This is the second collaberation announced by Neurocine in as many days. On Wednesday the company reported that they had entered into a collaboration agreement with Abbott to develop and commercialize elagolix for the treatment of endometriosis-related pain.
Orexigen Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA). The Company had announced on June 1, 2010 that the FDA accepted the Contrave NDA filing for review. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
"It's an exciting year for Orexigen as we move through the review process of the Contrave NDA," said Michael Narachi, President and CEO of Orexigen. "We believe that if approved, Contrave will become an important therapeutic option for obese patients, making weight loss and weight maintenance an achievable cornerstone in the treatment of obesity and its common co-morbidities."
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.
Jevtana, a microtubule inhibitor, in combination with prednisone was approved based on results from the Phase 3 TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. The study showed that patients who received a treatment regimen including Jevtana lived for about a year and three months after starting treatment while those that received standard treatment lived for about a year and three weeks.
This is a proud time for sanofi-aventis Oncology. Phase III study results with Jevtana were significant for a prostate cancer compound since it successfully demonstrated a survival benefit compared to active control in a second-line treatment setting," said Debasish Roychowdhury, M.D., Senior Vice President, Global Oncology, sanofi-aventis. "Jevtana builds on sanofi-aventis Oncology's long legacy of providing innovative oncology medicines to patients around the world."
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP.ob) and Jan Marini Skin Research, Inc. ("JMSR") have entered into a licensing agreement providing JMSR with the exclusive U.S. rights to Transdel's transdermal delivery technology for use in an anti-cellulite cosmeceutical product for the dermatological market.
Under the terms of the agreement, JMSR will pay Transdel a licensing royalty on the U.S. and worldwide sales of an anti-cellulite product using Trandel's delivery technology. JMSR obtained an exclusive right to promote and sell a product in the U.S. dermatological market for approximately one-year after which time they have a non-exclusive right. Also, JMSR obtained a non-exclusive right to promote and sell the product in the ex-U.S. dermatological market.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines. All seven patients who enrolled in the trial displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures following a single treatment with XOMA 052, a therapeutic antibody candidate that inhibits the inflammatory cytokine interleukin-1 beta (IL-1 beta).
Allos Therapeutics, Inc. (Nasdaq:ALTH) announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of cutaneous T-cell lymphoma (CTCL).
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for the "John et al." patent (Application No. 10/384,463), which covers methods of inhibiting mutant genes with double-stranded RNAs from 19 to 30 nucleotides in length.
BioElectronics Corporation (PINKSHEETS:BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, and YesDTC Holdings (OTCBB: YESD), BioElectronics' exclusive distributor in Japan, today announced several important product line enhancements specifically tailored to suit the needs of the highly discerning and quality-conscious Japanese marketplace.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that Jeffrey Cooper, Chief Financial Officer of BioMarin, will present a company update at the Wells Fargo Healthcare Conference in Boston on Thursday, June 24, 2010 at 2:30 p.m. ET.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced the results of its 2010 Annual Meeting of Stockholders that took place on June 17, 2010 at the Company’s headquarters.
Celsion Corporation (Nasdaq: CLSN), a biotechnology drug development company that is leveraging its Heat Sensitive Liposomal Technology platform to encapsulate and deliver high concentrations of proven chemotherapeutics, today announced that it has secured a committed equity financing facility under which it may sell up to $15 million of common stock to Small Cap Biotech Value, Ltd. over a 24 month period.
Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that Andrei Gudkov, Ph.D., D. Sci., the Company's Chief Scientific Officer and Senior Vice President of Basic Science at Roswell Park Cancer Institute, is scheduled to speak at the St. Petersburg International Economic Forum (SPIEF), June 17-19, in St. Petersburg, Russian Federation.
CytoDyn, Inc. (Pink Sheets: CYDY) has elected Kenneth J. Van Ness to the Board to fill a vacancy. Mr. Van Ness holds a substantial position in CytoDyn and is well versed on the Company's opportunities and business plan.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain.
Marshall Edwards, Inc. (NASDAQ: MSHL), an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today the appointment of industry veteran Thomas Zech as Chief Financial Officer, less than two months after appointing Daniel P. Gold, Ph.D., as the Company's new Chief Executive Officer.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Tarek Sherif, CEO, and Glen de Vries, President, have been honored with the Ernst & Young Entrepreneur Of The Year® 2010 Award for the Metro New York area.
Omnicell, Inc. (Nasdaq: OMCL), a leading provider of system solutions to acute healthcare facilities, today announced that KLAS, a prestigious healthcare research firm, has named Omnicell's OmniRx® automated dispensing system the recipient of its 2010 Best in KLAS award for Automated Medication Dispensing Units for large hospitals with more than 200 beds.
Pall Corporation (NYSE:PLL) is donating leftover polypropylene membrane from its manufacturing operations in Pensacola, Florida, to help protect local beaches from the Gulf oil spill.
Repros Therapeutics Inc. (NasdaqGM:RPRX) received notification from NASDAQ that it has granted the Company the opportunity for an oral hearing to plead its case for an extension of time before delisting associated with the $1 share price requirement per NASDAQ Listing Rule 5550(a)(2).
Roche NimbleGen (SIX:RO) (SIX:ROG) (OTCQX:RHHBY) is pleased to announce that imaGenes GmbH, located in Berlin, Germany, has passed the certification process to quality as a Roche NimbleGen Certified Service Provider (CSP) for Comparative Genomic Hybridization (CGH).
SciMeDent Health, Corp. f/k/a Trend Exploration, Inc. (PINKSHEETS: TRDX) today announces it has executed a binding Letter of Intent with Montreal-based Genesis Bio Pharma, Inc. to acquire an exclusive worldwide sublicense for a new compound in development for the treatment of Painful Diabetic Neuropathy (PDN).
WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genetic analysis systems, today announced that scientists from Kyoto University will use the WaferGen SmartChip Real-Time PCR System to identify and compare biomarkers to advance their research to regenerate tissues such as bone, cartilage, and muscle, lost or reduced due to various causes.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it will hold its Annual Meeting of Stockholders on Wednesday, June 23, 2010 at 10:00 a.m. EST at the Grand Hyatt New York, Executive Board Room #1418. Stockholders of record at the close of business on May 10, 2010 are entitled to vote at the Annual Meeting.
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