ReNeuron plc is planning to move its stem cell therapy ReN001 into a Phase I trial in critical limb ischemia (CLI), just as Aastrom Biosciences Inc., an erstwhile leader in the field, is stepping away from the fray. (See BioWorld Today, March 28, 2013.) Guildford, UK-based ReNeuron is also in the process of wrapping up a Phase I trial of ReN001 in stroke patients and plans to initiate a Phase II study in that indication in the second half of the year. ReN001 is based on a neural stem cell line
By Cormac Sheridan | BioWorld International | Wednesday, April 3, 2013
Anaeropharma Science Inc., of Tokyo, initiated a Phase I trial of APS001F in U.S. patients with advanced or metastatic solid tumors whose disease is no longer responsive to available treatments. The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors. The therapy is expected to limit the systemic toxicity of the antitumor agent 5-FU. Convergence
Shares in ChronTech Pharma AB plunged as much as 40 percent during trading Tuesday on news that ChronVac-C, the company's therapeutic DNA vaccine for treating hepatitis C virus (HCV) infection, failed to attain efficacy in an interim analysis of data from a Phase II trial. Its partner, electroporation device developer Inovio Pharmaceuticals Inc., of Blue Bell, Pa., sustained collateral damage. Its stock (NYSE:INO) was off almost 10 percent early Tuesday afternoon. Comprising a plasmid encoding
By Cormac Sheridan | BioWorld International | Wednesday, April 3, 2013
LONDON – Clavis Pharma A/S is facing a merger or an orderly shutdown following the Phase III failure of elacytarabine, its lipid-enhanced version of cytarabine, in the 380-patient CLAVELA trial in advanced acute myeloid leukemia (AML). This is the second big failure of the lipid technology in five months, with Clavis reporting in November that CO-101 (CP-4126), a modified formulation of gemcitabine, had not shown any effect on overall survival in a 360-patient pivotal Phase II study in
By Nuala Moran | BioWorld International | Wednesday, April 3, 2013
LONDON – SEEK Ltd. has raised £25 million (US$37.9 million) to fund its spin-off, infirst Healthcare Ltd., toward an independent existence as a specialist in patent-protected over-the-counter (OTC) treatments. Meanwhile, SEEK is poised to advance the lead products in its in-house portfolio of vaccines and antiviral drugs into Phase III, with trial designs approved and the hunt for partners advancing. The funding for infirst, from the London-based investment firm Invesco Asset Management, will be
BioWorld International | Wednesday, March 27, 2013
Schizophrenia claimed another victim last week as shares of BioLineRx Ltd. plummeted after the company halted the Phase II/III CLARITY trial of BL-1020, its first-in-class, orally available GABA-enhanced antipsychotic and the lead program in the company's diverse pipeline. Results from a pre-planned interim analysis indicated the trial would not meet the pre-specified primary efficacy endpoint of improving cognitive function at six weeks or the secondary endpoints of long-term cognition at 12
By Marie Powers | BioWorld International | Wednesday, March 27, 2013
Underlining its ambitions in ophthalmology, Shire plc is acquiring SARcode Bioscience Inc. for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease. The acquisition, which is expected to close in the second quarter, comes hot on the heels of its recent purchase of Premacure AB, of Uppsala, Sweden. The latter firm is
By Cormac Sheridan | BioWorld International | Wednesday, March 27, 2013
LONDON – The part of the immune system that deals with viruses and other pathogens can also delay the healing of bone fractures, a new study has found. People with a high level of a particular type of T cell in their blood are more likely to suffer delayed healing of bone fractures, or even nonunion of the broken bones, the study showed. Up to 15 percent of people who break a bone experience delayed or nonunion healing, an outcome which has serious socioeconomic consequences, including further
By Sharon Kingman | BioWorld International | Wednesday, March 27, 2013
3SBio Inc., of Shenyang, China, called an extraordinary general meeting of shareholders for April 25 to vote on the merger plan with Decade Sunshine Ltd. and its wholly owned subsidiary Decade Sunshine Merger Sub. The merger would result in 3SBio becoming a privately held subsidiary of Decade Sunshine Ltd., with its American Depository Shares no longer listed on the Nasdaq Global Market. The company's board of directors approved the merger agreement and recommended that shareholders vote to
BioWorld International | Wednesday, March 27, 2013
With additional data in the offing for its Leber's hereditary optic neuropathy (LHON) drug Raxone (idebenone), Santhera Pharmaceuticals AG has withdrawn its marketing authorization application (MAA) from the European Medicines Agency's (EMA) re-examination process and will instead submit a new file with an expanded patient database. The move will significantly delay the program but should, the company hopes, substantially improve its chances of success. Liestal, Switzerland-based Santhera
By Cormac Sheridan | BioWorld International | Wednesday, March 27, 2013
LONDON – The shape of the UK's new drug pricing regime became clearer last week when the government confirmed it is handing responsibility for assessing the value of medicines to the National Centre for Health and Clinical Excellence (NICE), a body that has repeatedly clashed with the industry over its decisions on whether or not drugs should be funded by the National Health Service. Currently, NICE gets to pass judgement once a product has marketing authorization and the price is agreed; when
By Nuala Moran | BioWorld International | Wednesday, March 27, 2013
LONDON – The cannabis-based drug specialist GW Pharma plc has filed for a listing on Nasdaq, with the ambition of raising up to $50 million to turbo-charge development of its preclinical pipeline and expand manufacturing capacity in anticipation of the U.S. launch of its lead product Sativex. "It's important for strategic reasons that we engage U.S. investors," Justin Gover, CEO told BioWorld International. The development of the company's product pipeline is increasingly focused toward the U.S
By Nuala Moran | BioWorld International | Wednesday, March 20, 2013
LONDON – AstraZeneca plc is once again taking the ax to its R&D operations, announcing plans to relocate 2,500 roles and cut about 1,600 jobs, mainly in the UK and U.S., as it consolidates discovery and development in Cambridge, UK; Gaithersburg, Maryland; and Mölndal, near Gothenburg, in Sweden. The recently appointed CEO of AstraZeneca, Pascal Soriot said the aim is to increase the company's R&D productivity. The changes "put science at the heart of everything we do," he said. This will
By Nuala Moran | BioWorld International | Wednesday, March 20, 2013
Sinovac Biotech Ltd.'s enterovirus 71 (EV71) vaccine looks good in preliminary results from Phase III data assessing efficacy, immunogenicity and safety against hand, foot and mouth disease (HFMD). The data showed that it was 95.4 percent efficacious against the disease in about 10,000 healthy infants between the ages of 6 months and 35 months. The rate of serious adverse events among infants receiving the vaccine was 2.2 percent, compared to 2.6 percent for those receiving a control vaccine, a
By Catherine Shaffer | BioWorld International | Wednesday, March 20, 2013
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong. Where contract research organizations (CROs) fit into the picture is not fully explained, though CROs do a great deal of clinical work in India. India's Ministry of Health & Family Welfare is asking for comment from drug
By Randy Osborne | BioWorld International | Wednesday, March 20, 2013
ThromboGenics NV is banking a €45 million (US$58.8 million) milestone payment from its partner, Alcon, a unit of Novartis AG, following formal European Union (EU) approval for Jetrea (ocriplasmin) for treating patients with vitreomacular traction (VMT), including those with a macular hole up to 400 microns in diameter. A second payment of €45 million will follow on the first EU sale of the drug, which are expected to occur in the coming weeks. The news was hardly unexpected, as the product was
By Cormac Sheridan | BioWorld International | Wednesday, March 20, 2013
LONDON – The genome of the tapeworm has been sequenced, providing researchers with a panoply of genes that may provide new targets for treatment of those parasites. Scientists hope that, by identifying tapeworm genes that are similar to human genes, it may be possible to select candidate drugs that are already approved for use against other conditions, such as cancer. Members of the multinational consortium that took part in the sequencing effort have already started testing laboratory cultures
By Sharon Kingman | BioWorld International | Wednesday, March 20, 2013
Newron Pharmaceuticals SpA and its partner, Zambon SpA, remain on track to file for approval for safinamide as add-on therapy in Parkinson's disease in the fourth quarter, following the release of pivotal Phase III data at the annual meeting of the American Academy of Neurology in San Diego this week. The drug attained the primary endpoints in two Phase III trials, MOTION, which recruited 679 patients with early stage disease, and SETTLE, which recruited 549 patients with mid-to-late-stage
By Cormac Sheridan | BioWorld International | Wednesday, March 20, 2013
Acuvax Ltd., of Brisbane, Australia, will acquire Biolife Science Ltd., also of Brisbane, and seeks to generate up to $5 million for Phase II trials of Biolife's HER-Vaxx vaccine for breast cancer, a potential alternative to Herceptin (trastuzumab, Roche AG). Acuvax is publicly listed on the Australian Securities Exchange (ASX:ACU) and will undergo a 200-to-1 share consolidation, after which it will seek to raise up to $5 million through placement of up to 25 million shares at A20 cents (US21
BioWorld International | Wednesday, March 20, 2013
LONDON – Start-up Helmedix Pty Ltd. has raised A$1.25 million (US$1.29 million) in seed funding, providing a springboard to the commercialization of molecules based on immune-modulating peptides used by helminth parasites to suppress the immune response of their hosts. "This is at a very early stage; the funding will cover the early stages of work to try and make variants around these compounds and to tease out the mode of action," said Stephen Thompson, a director of Helmedix and partner at
By Nuala Moran | BioWorld International | Wednesday, March 20, 2013
ReNeuron plc is planning to move its stem cell therapy ReN001 into a Phase I trial in critical limb ischemia (CLI), just as Aastrom Biosciences Inc., an erstwhile leader in the field, is stepping away from the fray. (See BioWorld Today, March 28, 2013.) Guildford, UK-based ReNeuron is also in the process of wrapping up a Phase I trial of ReN001 in stroke patients and plans to initiate a Phase II study in that indication in the second half of the year. ReN001 is based on a neural stem cell line