LONDON – Photocure ASA claimed it has taken photodynamic therapy (PDT) "to a completely new level," as it published positive data from the final analysis of the 262-patient Phase IIb trial of Cervira in treating oncogenic human papillomavirus (HPV) infections and pre-cancerous lesions of the cervix. The product is now ready to enter Phase III, and the company is in talks with potential partners. "We want a strong partner with a strategic focus on women's health care before undertaking further

LONDON – Gene therapy start-up GenSight Biologics has raised €32 million (US$41 .6 million) in a Series A funding, hinting that following on from the first European regulatory approval of a gene therapy and with an increasing volume of positive clinical data, this iconic field is now de-risked in the eyes of venture capital investors. The money will fund the ophthalmology specialist until 2016, enabling it to advance two products into Phase II for the treatment of Leber's hereditary optic

SHANGHAI – As the S&P 500, the Dow Jones Industrial Average and the Nasdaq Biotechnology Index close at record highs, one might think that respectable Chinese biopharmas on the New York Stock Exchange or Nasdaq would be well positioned to enjoy the benefits of such a robust stock market. In fact, many are cutting their ties. In the middle of this record-setting market behavior: 3SBio Inc., of Shenyang, China, announced that it will hold an extraordinary general meeting of shareholders on April

S-TARget therapeutics GmbH, an Austrian start-up developing therapeutic vaccines for allergies, aims to close a €6 million (US$7.8 million) Series A funding round in the coming months. The company has just started a second preclinical study in nonhuman primates of its lead product, SG100, which is in development for treating house dust mite-induced asthma. A readout is expected in late July, by which time the Vienna-based firm also hopes to have completed due diligence with investors

LONDON – Scientists are close to identifying new genes that may be linked to several eye diseases in humans, many of which cause blindness. The researchers are being guided by genes they have found in mice that, when absent, cause similar defects to those occurring in the eyes of humans who are affected by conditions such as one type of age-related macular degeneration (AMD). The genes that, in their absence, lead to the development of various visual defects in mice are known to play a key role

LONDON – Cancer specialist Activartis Biotech GmbH will present positive survival data from the Phase II trial of its dendritic cell therapy in treating glioblastoma at the American Association of Cancer Research (AACR) Wednesday, as it steps up efforts to find a partner to back a Phase III study. The first interim analysis of the open-label, 100-patient trial indicated that when the final numbers are in there will be an overall survival benefit in patients treated with AV0113, which consists

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, reported results of a Phase II study in acromegaly patients showing that Somatoprim, its somatostatin analogue, demonstrated a dose-dependent effect on lowering excess growth hormone in treatment-naïve patients. No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature. The trial was designed to test single-ascending doses of Somatoprim in up to 20 patients. Axelar AB, of Stockholm

MedDay raised €8 million (US$10.5 million) to take forward three drug development programs, two of which already have yielded promising data in small-scale human trials, in progressive forms of multiple sclerosis (MS) and in treatment-resistant forms of psychotic illness. The company was formed in 2011 but has been operating in stealth mode until now. It initially was formed to commercialize 10 years of research into inherited rare neurological diseases by company co-founder Frédéric Sedel, a

LONDON – A fault in glucose metabolism lies at the heart of polycystic kidney disease, a common inherited condition that can cause end-stage renal failure by the age of 50, new research has shown. The discovery suggested that it may be possible to treat the disease with existing drugs that interfere with glucose metabolism, slowing the development of the cysts in the kidneys and conserving the function of normal kidney tissue. Alessandra Boletta, associate scientist at the Dulbecco Telethon

Themis Bioscience GmbH is planning to begin clinical trials of viral vaccine candidates to protect against dengue virus and chikungunya virus infections before year-end, following successful preclinical proof of concept studies. The data indicated a single shot was sufficient for protection in the case of chikungunya virus, while the dengue vaccine elicited an immune response against all four serotypes of the virus. The Vienna, Austria-based company is developing recombinant live attenuated

LONDON – Following the FDA approvals of the first two antibody-drug conjugates (ADCs), the market is moving forward to develop enhanced products based on linker technologies that will make that new class of biopharmaceutical/small-molecule hybrids safer, more effective and easier to manufacture. Enter Synthon Biopharmaceuticals, which is poised to discuss details of its lead ADC product at the American Association for Cancer Research (AACR) meeting in Washington, April 9, highlighting increased

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

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

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

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

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

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

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