|Acadia Pharma surges on new Parkinson's Phase III trial. CytRx's drug eradicates former NBA player's advanced-stage Leukemia. After the bell: Orexigen higher on weight loss data|
|By BioMedReports.com Staff|
|Thursday, 29 July 2010 18:32|
Below is a list of the companies that made news in the healthcare sector on Thursday, July 29, 2010.
Orexigen Therapeutics, Inc. (Nasdaq:OREX) after the bell announced that results from its COR-I trial of Contrave were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.
Shares of Orexigen shot up more than 15% in the after hours market, jumping 75 cents to $5.50.
Helicos BioSciences Corporation (NASDAQ: HLCS) moved higher in extended trading today. After the bell the company announced a publication demonstrating the detection and quantification of novel small RNA molecules using Helicos’ single-molecule sequencing technology. These data confirm a long-held, unproven hypothesis that mammalian cells are capable of synthesizing RNA by copying RNA molecules directly. The findings are presented in a paper, entitled "New class of gene-termini-associated human RNAs suggests a novel RNA copying mechanism," by Kapranov, et al, available today in Nature.
"For the first time, we have evidence to support the hypothesis that human cells have the widespread ability to copy RNA as well as DNA," said Bino John, Ph.D., assistant professor of computational biology, University of Pittsburgh School of Medicine. "These findings emphasize the complexity of human RNA populations and suggest the important role for single molecule-sequencing for accurate and comprehensive genetic profiling."
In news from earlier in the day:
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it has initiated a new Phase III trial designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with Parkinson’s disease psychosis (PDP).
"This Phase III trial builds on the signals of efficacy observed in our earlier PDP studies and uses a refined study design that we expect will help mitigate the placebo response, reduce variability and enhance sensitivity in measuring the efficacy of pimavanserin in PDP patients," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals. "We believe pimavanserin has an ideal profile to effectively treat PDP without impairing motor function and, therefore, provides the potential for an important advance in therapy for patients suffering from this large unmet medical need."
Shares of ACADIA jumped more than 18% on the news, rising 20 cents to $1.28.
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced that an advanced form of acute promyelocytic leukemia, or APL, has been eradicated in former NBA player Ray Johnston following treatment with CytRx’s experimental cancer drug tamibarotene. Mr. Johnston was afflicted with a particularly aggressive type of APL called chloromas and had previously failed other approved therapies. More than 30 tumors were detected throughout his body prior to treatment with tamibarotene, which was administered in tablet form on a compassionate use protocol.
"Following four months of treatment with tamibarotene, the disease was totally eliminated," said Mr. Johnston. "In January, my PET scan showed a significant decrease in the disease, and in April it confirmed that the leukemia was completely gone. Last week marked my six-month anniversary of being cancer-free." Mr. Johnston will continue taking orally administered tamibarotene every other month as an added measure given his history of relapses.
Mr. Johnston, 31, was diagnosed with APL six years ago, ending his brief career as a Dallas Maverick. He previously was treated with FDA-approved therapies for APL, as well as with a blood stem cell transplant. He has experienced several remissions of his leukemia, but has always relapsed. In December 2009, his physician, Dr. Robert Collins at the University of Texas Southwestern Medical Center, requested tamibarotene from CytRx on a compassionate use basis, and the request was granted.
"We wanted to give tamibarotene a try for Ray given the fact that his APL has relapsed several times following treatment with all trans-retinoic acid (ATRA), anthracycline chemotherapy and arsenic trioxide (ATO), the current first- and second-line therapies. There currently is no approved third-line therapy for APL," said Dr. Collins. CytRx is conducting the Phase 2 STAR-1 registration trial under a Special Protocol Assessment to evaluate the efficacy and safety of tamibarotene in patients with third-line APL. In Japan, tamibarotene was approved in 2005 and is marketed for the treatment of second-line APL.
"I’ve regained my life following treatment with tamibarotene," added Mr. Johnson. "It is the best I have felt since I joined the Dallas Mavericks." Following his diagnosis, Mr. Johnston formed the band: The Ray Johnston Band, and has been featured on Dallas Mavericks’ owner Mark Cuban’s HDNet reality series – The Ray Johnston Band Road Diaries. Currently, the Ray Johnston Band is on tour in North America and has opened for Jimmy Buffet, The Cure, The Fray, and Los Lonely Boys, all internationally renowned performers.
Last week, CytRx announced that a 44-year-old female patient with advanced APL showed no evidence of disease in the blood cells and/or bone marrow following treatment with tamibarotene. This patient is enrolled in CytRx's Phase 2 STAR-1 registration trial, which is evaluating the efficacy and safety of this drug candidate as a third-line treatment for APL. She is one of three previously reported advanced APL patients to achieve a hematologic complete response with tamibarotene treatment in the STAR-1 trial. A detailed report of this patient, who also had failed first- and second-line APL treatments as well as a bone marrow transplant, was published in the July online issue of the peer-reviewed British Journal of Haematology with publication in the print edition expected later this year.
Steven A. Kriegsman, CytRx President and CEO, said, "We are thrilled with Ray’s response to tamibarotene. As important, we are highly encouraged about tamibarotene’s prospects now that several patients afflicted with advanced APL who have failed multiple other treatments are reporting total elimination of this disease with our drug. We estimate tamibarotene’s market opportunity in refractory APL in the U.S. alone to approach $20 million annually and, with an expanded label to include refractory, maintenance and front-line therapy, to increase to $150 million annually in the U.S. and Europe. Furthermore, in order to reach blockbuster status, we are evaluating the development of tamibarotene in other deadly cancers with large market opportunities."
On heavy volume, shares CytRx rose nearly 8% or 7 cents to close the day at $0.95.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), a biopharmaceutical company specializing in products for cancer and supportive care, today announced that it will host a conference call at 11:00 a.m. EDT on August 3rd, to provide an update on the Company's strategy and activities surrounding the official launch its lead product, MuGard in North America. Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.
Bionovo, Inc. (Nasdaq:BNVI) announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba.
"We are pleased with the outcome of our Scientific Advice meetings with the European Medicines Agency. We are eager to put this guidance to use and to start our late stage pivotal studies for Menerba," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the $4.1 million fourth milestone-based option on the Company's existing contract under the Broad Agency Announcement titled, "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation," for selected tasks in the advanced development of Protectan CBLB502. The value of the contract, originally awarded in September 2008, is $15.6 million, including an increase in the first milestone-based option, which was exercised in September 2009.
Cytori Therapeutics (NASDAQ: CYTX) has received European (CE Mark) approval for the PureGraft 250/PURE System for autologous fat grafting procedures, allowing Cytori to immediately commercialize the PureGraft product line to physicians in Europe. PureGraft will be sold as both a standalone product and as a complement to Cytori’s Celution 800/CRS System in Europe.
Icagen, Inc. (Nasdaq:ICGN) today provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. Pfizer and Icagen have initiated a clinical study in healthy volunteers of several collaboration compounds in order to assist in the selection of compounds for further clinical development. The initiation of this study triggers milestone payments to Icagen of $3 million. Pfizer has funded all aspects of the collaboration, including research and preclinical development efforts at Icagen, and has exclusive worldwide rights to commercialize products that result from the collaboration.
IRIDEX Corporation (Nasdaq:IRIX) today announced the receipt of an Issue Notification from the U.S. Patent and Trademark Office for U.S. Patent No. 7,766,904, "Adjustable Laser Probe For Use In Vitreoretinal Surgery." This patent applies to a number of consumable medical devices already in the IRIDEX product line, collectively identified and sold as Adjustable and Intuitive EndoProbe laser handpieces.
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) announced today that it has earned a $5 million milestone payment from GlaxoSmithKline (NYSE:GSK) related to the designation as a development candidate of a drug to treat an undisclosed rare and serious disease. Isis will develop the drug to Phase 2 proof-of-concept, at which time GSK has the option to license it.
NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) today announced that it has entered into a new line of credit with three of its existing shareholders, one of which is represented on the Board of Directors, to strengthen its financial position. This will allow the company further time to fully commercialize its lead solution, QTinno.
In conjunction with signing this credit line, the company withdrew the S-1 registration statement, previously filed with the Securities and Exchange Commission (SEC) as it does not currently intend to pursue the public offering. Management believes that the company has sufficient operating capital to sustain its operations and fund its business plan at this time.
The credit facility is part of a series of steps designed to improve the company's ability to identify and attract potential strategic relationships and/or investors, which is intended to enable the company to maximize the value to be derived through continued development of its 3D platform technology.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced that it has submitted a Marketing Authorization Application (MAA) for fidaxomicin to the European Medicines Agency (EMA) under the European Union's Centralized Procedure. Optimer is seeking approval to market fidaxomicin for the treatment of patients with Clostridium difficile infection (CDI).
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the Committee for Orphan Medical Products of the European Medicines Agency (EMA) has adopted a positive opinion and recommends the granting of orphan medicinal product designation for XOMA 052, an antibody to interleukin-1 beta, for the treatment of Behcet's disease.
Amarin Corporation plc (Nasdaq: AMRN) today announced that Dr. Declan Doogan, Interim Chief Executive Officer, is scheduled to present at the 30th Annual Canaccord Genuity Global Growth Conference on Thursday, August 12, 2010 at 1:30pm (EDT).
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.