|Teva to Commence Phase 3 CHF Trial; Xoma Shares Rise 6% After-Hours on Phase 2 Gevokizumab Results|
|By Staff and Wire Reports|
|Wednesday, 30 October 2013 20:42|
Regenerative medicine company Mesoblast Limited (OTC: MBLTY) announced the U. S. FDA has cleared the Investigational New Drug (IND) filing made by Mesoblast's development and commercial partner Teva Pharmaceutical Industries (NASDAQ: TEVA) to commence a Phase 3 trial in patients with chronic congestive heart failure using Mesoblast's proprietary Mesenchymal Precursor Cells (MPCs). The IND was cleared by the FDA within the minimum 30-day period following submission, and patient recruitment is expected to begin shortly.
The multi-center trial, which will be conducted by Teva, is planned to enrol approximately 1,700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the European Medicines Agency.
The Phase 3 trial design is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association (NYHA) class II or III disease and an ejection fraction ≤ 40%. The primary efficacy endpoint of the trial is a time-to-first event analysis of heart failure-related Major Adverse Cardiac Events (HF-MACE),
XOMA Corporation (NASDAQ: XOMA), a leader in the discovery and development of therapeutic antibodies, today announced very encouraging results from two Phase 2 clinical studies that are part of the Company's broad gevokizumab proof-of-concept ("POC") program.
Erosive Osteoarthritis of the Hand Phase 2 POC Study: The Phase 2 POC study in erosive osteoarthritis of the hand ("EOA") patients with elevated C-reactive protein ("CRP") levels greater than or equal to 2.5 mg/L is a double-blind, placebo-controlled study to determine if gevokizumab can improve the pain, stiffness, and physical function associated with EOA after three and six months of treatment, based upon the Australian/Canadian Osteoarthritis Hand Index ("AUSCAN™") scoring scale.
AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions. XOMA's study enrolled 85 EOA patients who were
ActiveCare, Inc. (OTCBB:ACAR), a leader in diabetes management wellness services, is pleased to announce the appointment of David Lee as the new chief operating officer.
Air Methods Corporation (Nasdaq:AIRM) will report financial results for the third quarter ended September 30, 2013 after the close of the market on Thursday, November 7, 2013.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today the closing of its previously announced public offering of 2,300,000 ordinary shares, including shares issued pursuant to the underwriters' over-allotment option, at an offering price of $16.50 per share.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced that it has moved to Janssen Labs @QB3 in San Francisco.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced a series of financial transactions, including the completion of a private placement of newly issued shares of common stock and common stock warrants, resulting in gross proceeds to the Company of $30.7 million.
BG Medicine, Inc. (Nasdaq:BGMD) today announced that the company will host a conference call and webcast on Wednesday, November 6 at 8:30 a.m. Eastern Time to discuss its third quarter 2013 financial results.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced it will report financial results for the third quarter of 2013 on Tuesday, November 12, 2013, prior to the market's opening.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, today announced that it has joined the social media conversation with a company blog and Twitter handle, which can be found at CatalystPharmaBlog.com and @CatalystPharma respectively.
Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) today reported financial results for the third quarter and nine months ended September 30, 2013.
Durata Therapeutics (Nasdaq:DRTX) has scheduled its quarterly conference call for Wednesday, November 6th at 8:30 a.m. Eastern Time to discuss third quarter 2013 financial results.
eHealth, Inc. (NASDAQ: EHTH), announced today that its chief executive officer, Gary Lauer will present at the 2013 Credit Suisse Healthcare Conference on Tuesday, November 12 at 3:00 p.m. MT.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and nine months ended September 30, 2013.
Eternity Healthcare Inc. (OTCBB:ETAH), or the "Company", a medical device company with technologies in drug delivery, and specialty pharmaceuticals, announced today that it has reached an agreement with Phoenix-based Global Medical Equipment of America (GMEA) to acquire 100% of the company through share exchange agreement. ETAH will issue GMEA, and all of the shareholders of GMEA approximately 40,000,000 of their shares in exchange for all of the shares of GMEA and all of their shareholders.
ExamWorks Group, Inc. (NYSE: EXAM), a leading provider of independent medical examinations ("IMEs"), peer reviews, bill reviews and related services, today reported financial results for the third quarter of 2013.
Incrediwear, a division of Star Nutrition, Inc. (PINKSHEETS: STAU), a California-based diversified health and wellness industry firm, has today announced a new agreement with Laro Suplidora, a Costa Rica-based provider of health, wellness and sporting goods products.
InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the third quarter and nine months ended September 30, 2013, and recent business highlights.
Masimo (NASDAQ: MASI) today announced its financial results for the third quarter ended September 28, 2013.
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX™ — a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. — that HempMedsPX™ recently presented a donation to augment the non-profit organization Hope4Harper's mission to fund CDKL5 epilepsy and seizure research through Dr. Frances Jensen, Chair of the Department of Neurology at the University of Pennsylvania.
MELA Sciences, Inc. (Nasdaq:MELA) the medical device company that has developed and is commercializing MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists in their fight against melanoma, today announced it has received a commitment from an institutional investor to purchase $6.0 million of the Company's equity in a registered direct placement.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced its financial and business results for the third quarter of 2013.
Novavax, Inc. (Nasdaq:NVAX) announced today that it will host a conference call and live webcast to report its third quarter 2013 financial results on Thursday, November 7, 2013, at 4:30 p.m. ET.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that it has initiated the patient screening process in the ERADICATE Hp study - a Phase III clinical study in the U.S. designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori (H. pylori) bacterial infection. Initiation of the RHB-105 Phase III clinical study follows the necessary approvals including FDA acceptance of the Company's Investigational New Drug (IND) application and Institutional Review Board (IRB) approval.
RCM Technologies, Inc. (Nasdaq:RCMT), a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty health care services, today announced financial results for its third quarter, the thirteen and thirty-nine week periods ended September 28, 2013.
Receptos, Inc. (Nasdaq:RCPT) today provided development program updates and announced financial results for the third quarter ended September 30, 2013.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) announced today that Rick Matros, the company's Chairman and Chief Executive Officer, Harold Andrews, the company's Chief Financial Officer, and Talya Nevo-Hacohen, the company's Chief Investment Officer, will be participating in NAREIT's annual convention, "REITWorld 2013," to be held November 13-15, 2013 at the Marriott Marquis in San Francisco, California.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that it will be participating in the Canaccord Genuity Medical Technology and Diagnostics Forum on November 14, 2013 in New York.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of the Phase 2 cohort of the Phase 1b/2, MD Anderson Cancer Center-sponsored study of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced today that trading of Surgical Care Affiliates, Inc. (SCA) (Nasdaq:SCAI), a leading surgical solutions provider for physicians, health systems and payers, commenced on The NASDAQ Stock Market on October 30, 2013.
ThermoGenesis Corp. (Nasdaq:KOOL) today announced a strategic reorganization initiative designed to better align resources with its expected cord blood revenue streams, increase its internal clinical resource capabilities and provide greater focus on new application development to improve the Company's market competitiveness and to speed AXP® AutoXpress® Platform (AXP) adoption in developed and emerging markets
United-Guardian, Inc. (Nasdaq:UG) announced today that its most important pharmaceutical product, Renacidin® Irrigation (Citric Acid, Glucono delta-Lactone, and Magnesium Carbonate) is once again available after a series of manufacturing issues resulted in the product being unavailable for over a year.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced very encouraging results from two Phase 2 clinical studies that are part of the Company's broad gevokizumab proof-of-concept ("POC") program.
ZELTIQ® (Nasdaq:ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced financial results for the third quarter 2013.