|Sunshine Heart Shares Sink Despite Rebooted Study; OXiGENE Announces Issuance of U.S. Patent for OXi4503|
|By William Kent|
|Tuesday, 26 May 2015 19:29|
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 26, 2015.
Sunshine Heart Inc. (NASDAQ: SSH) fell sharply on Tuesday despite restarting patient enrollment in a trial of its lead product for treating heart failure.
Shares of the Eden Prairie, Minnesota company are off more than 26 percent in the past three months, and changed hands recently down 3.5 percent at $4.13. Sunshine said Tuesday that the Food and Drug Administration approved a modified protocol as well as the resumption of patient enrollment in its pivotal study for the C-Pulse Heart Assist System.
Patient enrollment in the study, aimed at assessing safety of the device, was halted in March after several subjects died. All four of the reported patient deaths were determined to be non-device related, the company said in April.
Protocol modifications will exclude patients with certain severe disease and establish a committee to ensure the patients meet the study entry criteria. The modifications will improve the study "and should increase the likelihood of study success," Chief Executive David Rosa said in a statement.
The study had enrolled eight patients when it was halted in March and was on pace to enroll its total of 20 patients as an additional 50 patients were being evaluated.
The device aims to to increase blood flow to the coronary arteries by using balloon counter-pulsation applied outside the aorta. Its goal is to help sustain the patient's current condition or, in some cases, reverse the heart failure process.
Analysts on average maintain a Buy rating and a $10.14 target on Sunshine, according to FactSet.
OXiGENE, Inc. (NASDAQ: OXGN), a biopharmaceutical company developing novel therapies for the treatment of cancer, announced the U.S. Patent and Trademark Office has granted it a patent (U.S. Patent No. 9,040,500) related to the use of OXi4503 for the treatment of myeloid neoplasms, including acute myeloid leukemia (AML).
"The granting of this U.S. patent is a notable achievement for OXiGENE and strengthens our program in AML, a potential orphan indication for which there is a great unmet need," said Bill Schwieterman, M.D., OXiGENE's President and CEO. "We are looking forward to starting a new company-sponsored Phase 1/2 clinical study of OXi4503 for this indication later this year, as we work to advance and strengthen our clinical pipeline."
OXi4503 (combretastatin A1 di-phosphate) is a dual mechanism vascular disrupting agent (VDA) that has been observed to block and destroy tumor vasculature, resulting in extensive tumor cell death and necrosis. OXi4503 combines a VDA mechanism with cytotoxic activity. It is currently being evaluated in a Phase 1 investigator-sponsored study at the University of Florida in patients with relapsed and refractory AML and myelodysplastic syndrome (MDS). The study is also sponsored in part by The Leukemia & Lymphoma Society's Therapy Acceleration Program. OXiGENE is planning to initiate a Phase 1/2 trial of OXi4503 in patients with AML and MDS later this year.
Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that David Main, Aquinox's President & CEO, will present a corporate overview at the upcoming 2015 Jefferies Global Healthcare Conference on Wednesday, June 3rd at 8:30 AM Eastern Time.
AXIM Biotechnologies, Inc. (OTC:AXIM), a leader in industrial hemp biosciences, is proud to announce that the Company was recently recognized by Adopt-A-Soldier Platoon, Inc., a Veterans-focused non-profit organization, for its service though philanthropy.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that executives from BioCryst are scheduled to provide a corporate summary and update regarding the Company's programs at the Jefferies 2015 Healthcare Conference in New York on Tuesday, June 2, 2015 at 10:30 a.m. Eastern Time.
bluebird bio, Inc. (Nasdaq:BLUE) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Five Prime's proprietary human antibodies to an undisclosed cancer target for hematologic malignancies and solid tumors.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it will be participating in two upcoming investor conferences in June. Linda Marbán, Ph.D., Chief Executive Officer of Capricor will provide a company overview and update on its clinical development programs.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced today that it intends to call to order and then immediately adjourn its annual meeting of stockholders to be held at its Corporate headquarters on Thursday, May 28, 2015, at 10:00 a.m., local time.
CombiMatrix Corporation (Nasdaq:CBMX) announced today that Mark McDonough, President and Chief Executive Officer of CombiMatrix, will present at the LD Micro investor conference at 8:00 a.m. PDT / 11 a.m. EDT on Monday, June 1, 2015.
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced the company plans to participate in the William Blair 35th Annual Growth Stock Conference in Chicago, IL.
Richard E. Perlman, Executive Chairman and James K. Price, Chief Executive Officer of ExamWorks Group, Inc. (NYSE:EXAM), will present at the William Blair Growth Stock Conference, June 10th at 8:00 a.m. CT The conference will be held at the Four Seasons Hotel, Chicago, Illinois.
Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that David Pernock, Chairman and Chief Executive Officer, will present at the Jefferies 2015 Global Healthcare Conference at 11:00 a.m. EDT on Tuesday, June 2 in New York City.
Growblox Sciences, Inc. (OTCQB:GBLX), a biopharmaceutical company with state-of-the-art technologies in plant biology and cultivation designed to produce consistent medicinal cannabis, announced today the receipt of production-model GrowBLOX™ units for both GB Sciences Nevada (GBSN) and GB Sciences Puerto Rico (GBS PR).
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announces that the European Medicines Agency (EMA) has published on May 22, 2015 both its Public Opinion Summary (http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2015/05/WC500187066.pdf) and its record designation (http://ec.europa.eu/health/documents/community-register/html/o1480.htm) approving the Orphan Medicinal Product Designation for Ampligen, also known as rintatolimod, an experimental therapeutic, to treat Ebola Virus Disease (EVD).
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced the Company plans to participate in the William Blair 35th Annual Growth Stock Conference in Chicago, IL.
Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that it will make the following presentations at the Jefferies 2015 Global Healthcare Conference in New York City: at 4:00PM ET on Tuesday, June 2, 2015, Mr. Peter Arduini, President and Chief Executive Officer of Integra, will present, and this presentation will be webcast; at 1:30PM ET on Thursday, June 4, 2015, Mr. Keith Valentine, Chief Executive Officer of SeaSpine, will present, and this presentation will not be webcast.
Lumenis Ltd. (Nasdaq:LMNS), the world's largest medical laser company for surgical, ophthalmic and aesthetic applications, today announced that its management is scheduled to participate in the Jefferies 2015 Global Healthcare Conference in New York.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the closing of its underwritten public offering of 8,337,500 shares of its common stock at the public offering price of $19.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,087,500 additional shares of common stock.
NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients with cancer, today announced it is presenting a poster highlighting indoximod, an IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 29 through June 2.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel therapies for the treatment of cancer, today announced that the U.S. Patent and Trademark Office has granted it a patent (U.S. Patent No. 9,040,500) related to the use of OXi4503 for the treatment of myeloid neoplasms, including acute myeloid leukemia (AML).
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that its Chief Executive Officer Kenneth L. Waggoner and Chief Operating Officer Dr. Gerald W. Crabtree will attend the American Society of Clinical Oncology's (ASCO) 51st annual meeting to be held May 29 through June 2, 2015, at McCormick Place in Chicago.
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced the appointment of Charlotte Arnold to the position of Vice President, Corporate Communications. Ms. Arnold joins Relypsa with more than 15 years of experience in corporate and product communications.
Repligen Corporation (Nasdaq:RGEN) today announced its upcoming presentation at the Jefferies 2015 Healthcare Conference to be held June 1-4, 2015 at the Grand Hyatt in New York. Tony J. Hunt, Repligen President and Chief Executive Officer, will present a Company overview on Wednesday, June 3, at 8:00 a.m. EDT.
Stericycle, Inc. (Nasdaq:SRCL) will participate in the Stifel Investor Summit at WasteExpo at the Las Vegas Convention Center with Brent Arnold, COO, and Frank ten Brink, Senior Vice President, Mergers and Acquisitions, hosting investor meetings on Monday, June 1st.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Sunil Agarwal, M.D., the company's Chief Medical Officer, will be presenting at the Jefferies 2015 Global Healthcare Conference on Tuesday, June 2, 2015 at 10:00am ET in New York.
XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announced today that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.