|Abbott hepatitis drug 93% effective in small study; GTx Submits Clinical Hold Complete Response Letter To FDA|
|By Staff and Wire Reports|
|Wednesday, 04 April 2012 18:27|
A combination of experimental oral hepatitis C treatments being developed by Abbott Laboratories (NYSE:ABT) led to cure rates of more than 90 percent in previously untreated patients, according to data from a small mid-stage study.
The data, to be presented at a major European liver meeting this month, puts Abbott firmly in the crowded race to produce a short duration, interferon-free treatment regimen for the serious liver disease.
"This demonstrates unprecedented cure rates for the most common form of hepatitis C infection. And we were able to achieve those rates with only a 12-week duration of therapy," said Scott Brun, Abbott's divisional vice president for infectious disease development.
Abstracts, or brief summaries, of studies to be presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona were made available on Wednesday.
"At EASL it's going to be very clear that we've reached a really transformational moment for patients with HCV (hepatitis C virus)," Brun said.
The Phase II trial of previously untreated patients, known as Co-Pilot, combined Abbot's protease inhibitor ABT-450 boosted by the antiviral drug ritonavir with its polymerase inhibitor ABT-333 and ribavirin, a drug that is part of all current hepatitis C regimens.
Patients received the combination therapy for 12 weeks and were checked 24 weeks later for signs of the virus in the blood to determine whether there was a sustained virologic response, or SVR. Any patients that achieved an SVR 24 weeks after completing treatment are deemed to be cured.
Eighteen of the 19 patients who received a 250 milligram dose of ABT-450 as part of their combination achieved SVR, or 95 percent, while 13 of 14 patients who got a 150 mg dose of ABT-450 were deemed to be cured, or 93 percent.
In a third arm of the study that involved patients who had failed to be helped by the former standard treatment of interferon and ribavirin, eight of 17 patients achieved SVR for a cure rate of 47 percent.
Abbott is also testing a drug from a promising class known as NS5A inhibitors in various all-oral combinations that it believes may improve cure rates for prior non-responders.
"For a first step it's very encouraging," Brun said of the new data in non-responders. "If you're able to add the potent NS5A inhibitor into the mix we think there's the potential to do even better and that's currently under study."
There were no serious side effects seen in the study, with the most common side effects fatigue, nausea and headache.
GTx, Inc. (Nasdaq: GTXI) announced the Company has submitted to the U.S. Food and Drug Administration (FDA) a complete response to the FDA’s letter regarding the previously announced Full Clinical Hold of the Company’s clinical trials evaluating Capesaris® (GTx-758) for primary (first line hormonal) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal therapy.
The FDA’s letter specified the information required by the FDA for the Company to resolve the safety related clinical hold deficiency seen in its recent clinical studies before the Company can initiate further clinical studies of Capesaris. The Company’s response provides the information requested by the FDA and includes its development plans for Capesaris as a secondary hormonal therapy for advanced prostate cancer at doses lower than those previously tested by the Company.
Assuming the FDA determines the Company’s response to be a Complete Response to its Full Clinical Hold letter by adequately addressing the FDA’s request for information to resolve the clinical hold deficiency, the FDA has stated that it will provide the Company a decision whether to lift the clinical hold on further Capesaris development within thirty (30) days of the Company’s submission.
AECOM Technology Corporation (NYSE: ACM), a leading provider of professional technical and management support services for public and private sector clients in more than 130 countries around the world, announced today that the U.S. Agency for International Development (USAID) has awarded the company a US$14.7-million contract to support the Mozambique Health Infrastructure Development Program.
AmerisourceBergen Corporation (NYSE: ABC) today announced that it plans to release its results for the 2012 Fiscal Second Quarter on Thursday, April 26, 2012 prior to the opening of trading on the New York Stock Exchange.
Bristol-Myers Squibb Company (NYSE:BMY) announced today that 20 abstracts on the Company’s research in liver disease have been accepted for presentation at The International Liver CongressTM 2012, the 47th annual meeting of the European Association for the Study of the Liver (EASL), in Barcelona, April 18 – 22.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a clinical-stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced today that the transfer of technology from the University of Pennsylvania to a second manufacturing site is complete.
Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that its first quarter 2012 financial results will be released before the market opens on Tuesday, May 1, 2012 and will be available on Impax’s Web site at www.impaxlabs.com.
Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of nutritional supplements based on Real Food Technology® solutions, announced the presentation of product research at the prestigious 10th Jenner Glycobiology and Medicine Symposium, which was held in The Hague, the Netherlands, March 31–April 3, 2012.
NXP Semiconductors N.V. (NASDAQ: NXPI) today launched the most efficient Schottky rectifier available in the ultra-small and flat 1.0 x 0.6 x 0.37-mm plastic SMD package DFN1006D-2 (SOD882D).
Roche (SIX: RO, ROG; OTCQX: RHHBY) today sent a second letter to shareholders of Illumina, Inc. (NASDAQ: ILMN) urging them to tender their shares into Roche’s increased offer and vote for Roche’s independent director nominees and other proposals at the 2012 Illumina annual meeting to be held on 18 April 2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the presentation of preclinical results on the use of ganetespib, the most advanced heat shock protein 90 (Hsp90) inhibitor in clinical development, in melanoma and colorectal cancer at the 103rd Annual Meeting American Association for Cancer Research (AACR).
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the first quarter 2012 before the market opens on Wednesday, April 25, 2012, and will hold a conference call on the same day at 8:30 a.m. EDT.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), has appointed Leland J. Gershell, M.D., Ph.D. as Chief Financial Officer and Bruce L. Daugherty, Ph.D., M.B.A. as Senior Director of Drug Development.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) announced today that it has received $682,699 (CDN) as the result of a 99.9% exercise of warrants that expired between the end of this March and the first week of April.
Walgreens (NYSE: WAG) (NASDAQ: WAG) had March sales of $6.02 billion, a decrease of 4.3 percent from $6.29 billion for the same month in fiscal 2011.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it was awarded U.S. Patent 8,148,414 for “Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical Compositions Thereof, and Methods of Use.”