The company said those findings supported the general safety of routine vaccine with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers

The trial will have two stages: The first stage will treat patients with escalating doses of SGI-100 and carboplatin to identify the maximum-tolerated dose and preliminary biological and clinical activity, while the second stage will randomize patients to receive SGI-100 plus carboplatin or one of three treatments of choice as determined by the clinical investigator – toptecan, pegylated liposomal doxorubicin or paclitaxel...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of

Clinical trials now represent an aggregate expense of approximately $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...The PCAST report is timely, given that industry concern about the cost and inefficiency of clinical trials prompted formation of the nonprofit TransCelerate BioPharma Inc., the pharma industry's initiative to accelerate drug commercialization that was officially launched last week

Proceeds will be used to fund ACT's clinical activities, including its three ongoing Phase I/II trials for forms of macular degeneration, for development of its other clinical activities and for general corporate purposes...Horizon Pharma Inc., of Deerfield, Ill., priced an underwritten public offering of 21.42 million units, with each unit consisting of one share of its common stock and a warrant to purchase a half share of its common stock...Royalty Pharma has invested $25 million under its royalty

The company said the financing will enable them to complete a clinical study to confirm the positive treatment effects of Oxabact previously seen in patients with primary hyperoxaluria, a rare inborn autosomal genetic disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it closed a registered direct offering of approximately 3 million shares of its common stock at $3.85 per share for gross proceeds

Pluristem's platform already has captured the attention of pharma...Proceeds will be used to support clinical studies, R&D activities and for general corporate purposes, including working capital and administrative expenses...Neuralstem Inc., of Rockville, Md., priced a registered direct offering of 7 million shares at $1 apiece for gross proceeds of $7 million to support working capital, capital expenditures, R&D activities, clinical trials and acquisitions of new technologies or businesses

Vascular Pharma will receive an up-front payment and milestone payments in exchange for the acquisition rights...Vascular Pharma expects its funding to last through completion of Phase II, getting the company to the point where Janssen may exercise its option...Pharma giants Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, have thrown their hats into the ring, as well

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said clinical results published in The Lancet showed the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types

Eaton Scientific Solutions Ltd., of Beverly Hills, Calif., a subsidiary of Pristine Solutions Inc., said it is finalizing preparations for a clinical program testing Tropine 3, which contains FDA-approved anticholinergic drug Homatropine, in an oral suspension...Proacta Inc., of San Diego, said the FDA cleared its investigational new drug application for clinical testing of PR610, a hypoxia-activated, irreversible multikinase inhibitor aimed at treating cancer...The first clinical study, to be

Meritage Pharma Inc., of San Diego, began a Phase II trial of oral budesonide suspension for eosinophilic esophagitis...The trial will be carried out at clinical centers in the U.S

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC

The FDA did not cite clinical safety or efficacy issues and did not request additional pre-approval studies, but the agency did raise questions relating to chemistry, manufacturing and controls, as well as issues related to a facility inspection at a third-party manufacturer. (See BioWorld Today, March 28, 2012.) The company completed an end-of-review meeting with the FDA in June to seek clarity from the agency in developing its response...Horizon Pharma Inc., of Deerfield, Ill., filed an S3 shelf

A.P. Pharma Inc., of Redwood City, Calif., said it is raising about $53.6 million through a private placement with certain new and existing institutional investors for 102 million shares priced at 5.25 cents per share...A.P. Pharma is developing APF530, a 5-HT3 antagonist formulated with its Biochronomer drug delivery system, for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting...Shares of A.P. Pharma (OTCBB:APPA) fell 7 cents, or 10.6 percent, to close

Dublin, Ireland-based pharma firm Shire plc also joined the round as a strategic investor...Proceeds from the financing also will support manufacturing, clinical and commercial infrastructure...Proceeds will support clinical trials of Nexagon, CoDa's lead candidate based on gap junction modulation for treating chronic wounds, including venous leg ulcers and diabetic foot ulcers

Berg Pharma LLC, of Boston, began a Phase I trial of compound 31543 for chemotherapy-induced alopecia...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study testing CRLX101 in platinum-resistant ovarian cancer...Results were published online in the Clinical Journal of Pain, ahead of the print edition

The company is partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, and recently expanded the collaboration to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's development capabilities and protein expression platform...The company plans to use the proceeds to complete clinical development of lead candidate dalbavancin, currently in a second pivotal Phase III trial in skin infections, and to fund commercialization activities in the U.S...LLC and CRT

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat

The company plans to use the proceeds to fund clinical trials, R&D activities and other corporate programs...Gemmus Pharma Inc., of San Francisco, closed a Series A round to advance its host-targeted treatment for influenza...The company plans to use the proceeds to cover the costs of clinical trials for its product pipeline, including CompleoTRT A bioadhesive intranasal testosterone gel, which is in a Phase III study in hypogonadism, to acquire manufacturing equipment and for other corporate purposes

The pivotal clinical study results were presented during the American Academy of Neurology annual meeting in April 2012. (See BioWorld Today, April 30, 2012