|AspenBio shares soar. International Cell shares plummet. Pressure BioSciences surges on study data.|
|By BioMedReports.com Staff|
|Tuesday, 26 October 2010 18:47|
After the bell Tuesday shares of Myriad Genetics, Inc. (Nasdaq:MYGN) moved higher after the company announced that it has signed an agreement with Abbott Laboratories, a global health care company, to conduct BRCA1 and BRCA2 mutation testing on patients to be enrolled in a Phase III multi-center, multi-national clinical study of a novel drug candidate for the treatment of metastatic breast cancer. This agreement is in addition to a similar previous agreement for a Phase II study with the same Study Drug.
Under the agreement, Myriad will use its BRACAnalysis test to identify the presence of germline mutations in the breast cancer patients to be enrolled in the Study. Myriad will determine the mutation status of these patients and will provide standard test reports to the clinicians at each study site.
Shares of GTx, Inc. (Nasdaq:GTXI) dropped sharply after the bell today after the company announced that it is offering to sell shares of its common stock in an underwritten public offering. On heavy volume shares fell more than 10%.
AspenBio Pharma, Inc. (NASDAQ:APPY) saw its shares rocket today after the company announced that it has initiated manufacturing of its AppyScore cassette-based test system to be used in further validation and verification testing of AppyScore -- a novel, blood-based diagnostic test designed to aid emergency department physicians in the difficult challenge of evaluating patients suspected of having appendicitis. Initial pre-clinical market testing is anticipated to commence prior to the end of the fiscal year. In addition, the Company reported that it has made key additions to its team to support AppyScore's clinical development, regulatory submission and market launch planning. Aspen has contracted with Michael Wandell, PharmD to lead its human diagnostic products' clinical and regulatory strategy, including taking over primary responsibility for clinical validation study design and ongoing communications with the US Food and Drug Administration, and Erik Miller to spearhead commercial planning efforts, including pre-clinical field testing of the AppyScore system.
"Aspen has made significant progress advancing the AppyScore cassette-based test and we are excited to put the test in the hands of actual hospital users for feedback as we proceed towards our pivotal clinical trial," said Steve Lundy, President and Chief Executive Officer. "In addition, both Mike and Erik bring a significant level of expertise from the diagnostic field and they will play an important role in helping Aspen advance our regulatory and commercial planning efforts for AppyScore in a focused and cost-effective manner."
On volume of nearly 5 million shares, AspenBio rallied as high as 98 cents before selling off late in the day to close at 71 cents, up 14 cents or 25.19%.
Shares of International Stem Cell Corporation (OTCBB:ISCO.ob) went on a wild ride in Tuesday trading. Before the market opened the company announced that its wholly-owned subsidiary, Lifeline Skin Care, Inc., in partnership with an experienced OTC drug licensed manufacturer of cosmetic products, successfully manufactured its first scaled-up lots of stem cell-based skin creams, confirming that these unique products can be made in larger batch quantities and continue to meet Lifeline’s high quality standards. This marks an important milestone in proving that two new technologies, the derivation of human parthenogenetic stem cells, and the packaging and delivery of critical anti-aging ingredients, including those derived from stem cells, can be scaled-up into a level of production suitable to meet commercial levels of demand.
Lifeline Skin Care’s product development scientists have combined human parthenogenetic stem cell technology with the latest discoveries in skin rejuvenation to create its unique day and night skin care creams. ISCO’s scientists were the first to intentionally create human parthenogenetic stem cells from unfertilized human eggs, thus avoiding the ethical concerns of harming a viable human embryo. ISCO’s therapeutic research team discovered that such cells had qualities that made them suitable for skin care products, thus leading to the formation of ISCO’s wholly-owned subsidiary, Lifeline Skin Care. Valuable assistance from ISCO’s other wholly-owned subsidiary, Lifeline Cell Technology, allowed the rapid transition and scale-up of a research-based discovery into a quality-controlled commercial product. Lifeline Cell Technology is staffed with experts in the manufacture and quality control of cell based products.
According to Dr. Ruslan Semechkin, CEO of Lifeline Skin Care, "Although it will be necessary to continue to develop new technologies to further scale-up the production of our new skin care products, this first successful manufacturing run proves that the team of ISCO’s therapeutic research scientists, in combination with Lifeline Skin Care’s product development expertise and Lifeline Cell Technology’s manufacturing and quality control expertise, has the ability to quickly develop and commercialize new products using stem cell technologies."
Shares rose to as high as $2.00 before a sell off kicked in late in the day. A sell alert sent shares down sharply in late trading. The stock finished the day at $1.54, down 35 cents or 18.52%.
Pressure BioSciences, Inc. (Nasdaq:PBIO) soared today after the company announced that two scientific presentations at the 21st International Symposium on Human Identification have provided further evidence that pressure cycling technology ("PCT") offers an improved method for the extraction of DNA in the analysis of forensic evidentiary samples.
A study entitled Pressure Cycling Technology (PCT): Applications for Forensics DNA Analysis was presented by Ms. Pam Marshall, MS, et al., from the Institute of Investigative Genetics, Department of Forensics and Investigative Genetics at the University of North Texas Health Science Center (UNTHSC), Fort Worth, Texas. Results from the study showed an increase in DNA yield from forensic swab samples prepared with PCT compared to samples prepared without PCT. These results confirmed and extended the data presented by UNTHSC scientists at the 20th Human Identification Meeting in October 2009 and the Harvard Medical School Symposium on High Pressure in May 2010, where data were presented that showed significant improvements in DNA yield from challenging forensic samples using PCT.
Dr. Bruce Budowle, Executive Director of the Institute of Investigative Genetics at UNTHSC, said: "New analytical techniques offer forensic scientists the potential to detect lower quantities of DNA. To reach this potential, methods for preparing samples prior to analysis must be improved. For the past 18 months, we have evaluated PCT in this regard. The results we presented at the 21st Annual Human ID Meeting confirm our earlier, reported findings that increased yields of DNA are seen in samples after PCT treatment compared with samples not exposed to PCT. Consequently, we continue to pursue development of PCT as a viable method to enhance DNA recovery from forensic samples, since it is feasible that the benefits of PCT may lead to more solved cases."
On heavy volume shares of Pressure BioSciences shot up to an intraday high of $2.29 before settling at $1.80, up 25 cents or 16%.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, and ATEK Medical, a leading medical device manufacturer, today announced the formation of a new strategic partnership in which ATEK Medical will supply key components and technology for use in Aastrom's proprietary cell manufacturing process. This partnership is intended to replace a previous supplier relationship with a more comprehensive arrangement to strengthen Aastrom's long-term manufacturing capabilities. Aastrom plans to initiate its Phase 3 CLI program in 2011 and is also developing its cell therapy for the treatment of dilated cardiomyopathy (DCM).
Keryx Biopharmaceuticals (Nasdaq:KERX) reported today the randomization of the last patient in its short-term study component of its Phase 3 registration program of Zerenex (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. The Zerenex Phase 3 clinical program is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration. The Company expects to complete the study and report top-line data before the end of the year.
Vicor Technologies, Inc. (OTC.BB:VCRT), today announced that the Company has received approval from the Institutional Review Board (IRB) at the University of Mississippi Medical Center for a study to assess concussions in competitive athletes using its PD2i Analyzer. The study will be conducted in collaboration with the University of Mississippi Medical Center (UMMC) and Belhaven University. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i nonlinear algorithm and software. Vicor is currently in the process of commercializing diagnostics that accurately risk stratify specific target populations for future pathological events, including congestive heart failure patients for cardiac death resulting from arrhythmia or pump failure, diabetics for diabetic autonomic neuropathy (DAN), and trauma victims for imminent death absent immediate lifesaving intervention.
Also Tuesday:BioMed Realty Trust, Inc. (NYSE:BMR) announced that it has completed the previously announced acquisition of the Science Center at Oyster Point and the Gateway Business Park, two adjacent life science campuses in the South San Francisco life science market, comprised of a total of approximately 489,000 square feet of laboratory, office and industrial space.
BioNeutral Group, Inc. (OTC Bulletin Board:BONU), a specialty chemical technology-based life science company, announced today that it has completed successful testing of its AutoNeutral products with Visconti Limousines Inc., the established leader in premier motorcoach transportation in New York State's Hudson Valley and the northeastern United States.
China-Biotics, Inc. (Nasdaq:CHBT), the leading developer, manufacturer and distributor of probiotics products in China, today announced it will host a conference call at 8:00 a.m. Eastern Standard Time / 9:00 p.m. Beijing Time on Tuesday, November 9, 2010, to discuss the fiscal year 2011 second quarter and six months financial results for the period ended September 30, 2010.
Depomed, Inc. (NASDAQ: DEPO) announced today that it will release third quarter 2010 financial results after the market closes on Monday, November 1, 2010.
eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals and families, today announced its financial results for the third quarter ended September 30, 2010.
Genomic Health, Inc. (Nasdaq:GHDX) today announced that the company will host a conference call and webcast on Monday, November 8 at 4:30 p.m. Eastern Time to discuss its third quarter 2010 financial results.
Healthnostics, Inc. (PINKSHEETS:HNSS) announced the development of MobileCleanRoom.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced today that Idenix management will present a corporate overview at the Oppenheimer & Co. 21st Annual Healthcare Conference on Wednesday, November 3, 2010 at 3:20 p.m. ET at the Waldorf Astoria, New York City.
Insmed Inc. (Nasdaq:INSM), a biopharmaceutical company, today announced that it will host a conference call on Wednesday, November 3rd, at 8:30 AM ET, to discuss its financial results for the third quarter 2010.
Isilon® (Nasdaq:ISLN) today announced that the Max Planck Institute for Evolutionary Biology (MPI) has deployed Isilon scale-out storage to help power its leading-edge research in ecology and genetics.
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that it will release its third quarter 2010 financial results on Friday, November 5, 2010 before the financial markets open.
Mediware Information Systems, Inc. (NASDAQ:MEDW) announced today that the Company will release the financial results for the first quarter of its Fiscal Year 2011 on Tuesday, November 2nd.
MiMedx Group, Inc. (OTC Bulletin Board:MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today its results for the third quarter ended September 30, 2010.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Oppenheimer 21st Annual Healthcare Conference in New York.
Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that it has selected Nutritional Alliance to serve as its global sales agent for its Nyloxin pain relievers.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) is scheduled to present at Oppenheimer's 21st Annual Healthcare Conference at the Waldorf-Astoria Hotel in New York City on Tuesday, November 2, 2010, at 10:15 a.m. Eastern Time.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced today that interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN® in patients with metastatic colorectal cancer prior to surgical resection of liver metastases was presented at the International Symposium on Cytotoxic T-lymphocytes (CTL) and Immunostimulation being held in Pamplona, Spain.
SensiVida Medical Technologies Inc., (PINKSHEETS: SVMT), a developer and provider of minimally invasive diagnostic technologies and devices, announced today that it has published on its website a Letter to Shareholders sent on September 22, 2010.
Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV(TM).
Sun Healthcare Group, Inc. (NASDAQ:SUNH) today announced details concerning the anticipated timing of Sun's previously announced plan to restructure its business by separating its operating assets and its real estate assets into two separate publicly-traded companies.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced that it will release third quarter 2010 financial results before the market opens on Thursday, November 11, 2010.
Techne Corporation's (Nasdaq:TECH) consolidated net earnings for the quarter ended September 30, 2010 decreased 1.5% to $26.4 million or $.71 per diluted share compared with $26.8 million or $.72 per diluted share for the quarter ended September 30, 2009.
Telik, Inc. (Nasdaq:TELK) announced today that Telintra (Ezatiostat HCl), the company's lead therapeutic product candidate, has been selected by Windhover Information and its advisors as one of "The Top 10 Most Interesting Oncology Projects to Watch."
Unity Management Group, Inc. (PINKSHEETS:UYMG), a Health Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.
Verenium Corporation (Nasdaq:VRNM), a pioneer in the development and commercialization of high-performance enzyme solutions, today announced that it has renewed and extended its joint marketing agreement with Alfa Laval, a leading global provider of heat transfer, separation and fluid handling technologies, for Purifine® PLC.
Virtual Medical Centre, Inc. (OTCBB: VMCT) announced today that the company has been up-listed to the Over The Counter Bulletin Board market from the Pink Sheets.
Volcano Corporation (Nasdaq:VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that it will report its operating results for the third quarter and first nine months of fiscal 2010 on Wednesday, November 3.