A.P. Pharma Inc., of Redwood City, Calif., said patient enrollment in the open-label APF530 Phase II trial was completed. APF530 is designed for the prevention of acute and delayed chemotherapy-induced nausea and vomiting and contains granisetron, formulated with the company's Biochronomer system. The Phase II study was designed for patients receiving moderately emetogenic chemotherapy for cancer to evaluate pharmacokinetics, safety and tolerability. Measures of efficacy also were introduced in the study.
Aegis Therapeutics LLC, of San Diego, filed its first drug master file for Intravail with the FDA as part of its goal to enable intranasal delivery of peptide and protein drugs across a wide spectrum of disease categories. Intravail's absorption enhancement agents are designed to deliver peptide, protein and other small- and large-molecule drugs that can be administered only through injection. To date, the company has licensed Intravail for beta-interferon, low-molecular-weight heparin, and for three undisclosed pediatric drugs.
ALS Association in Calabasas Hills, Calif., awarded funding for a collaborative project to screen thousands of existing compounds for possible activity as ALS therapeutics, using worms living in lab dishes that recreate aspects of amyotrophic lateral sclerosis. The grant gives continued support to the efforts of Richard Morimoto, of Northwestern University in Evanston, Ill., who created a worm that expresses the mutant gene for copper-zinc superoxide dismutase, responsible for some inherited cases of ALS. Morimoto will collaborate with Woburn, Mass.-based Cambria Biosciences LLC to carry out high-throughput screening of several libraries of compounds.
Array BioPharma Inc., of Boulder, Colo., received FDA clearance to begin clinical studies of ARRY-334543. The company said it would begin Phase I this fall at two academic medical centers in the U.S. and Canada to evaluate the product's tolerability and pharmacokinetics following oral administration to patients with advanced cancer. The dual growth factor inhibitor, the company's second small-molecule anticancer compound, disrupts both ErbB-2 and EGFR.
GeneGo Inc., of St. Joseph, Mich., a provider of databases, software and services in systems biology, reported that it received a Phase II SBIR grant from the National Institute of General Medical Science. The grant enables the development of a computational tool MetaDrug to improve the prediction of ADME and toxicology properties of small-molecule compounds.
GTC Biotherapeutics Inc., of Framingham, Mass., agreed to sell about 4.6 million shares of common stock at $1.75 per share to institutional investors to raise nearly $8 million. Investors also will receive 5-year warrants to purchase an aggregate of about 1.8 million additional shares at an exercise price of $2.68 per share. Proceeds are expected to be used for general corporate purposes, including funding GTC's ongoing trial and commercialization activities for ATryn, pending marketing approval in the European Union. New York-based Rodman & Renshaw LLC acted as placement agent. Shares of GTC (NASDAQ:GTCB) fell 20.2 percent Monday, losing 47 cents to close at $1.86. In other news, a presentation at the 20th Congress of the International Society of Thrombosis and Haematosis in Sydney, Australia, demonstrated the therapeutic potential of recombinant human antithrombin supplied by GTC in a human model of sepsis. The trial showed that supra-physiological levels of antithrombin without concomitant heparin have dose-dependent anticoagulant effects and anti-inflammatory properties in human experimental endotoxemia.
Halozyme Therapeutics Inc., of San Diego, said its Hylenex product would be sold in the European Union by Baxter Healthcare Corp., of Deerfield, Ill., through an option agreement. A year ago, they entered an exclusive sales and marketing agreement under which both parties are equal partners in its commercialization upon FDA approval, with Baxter also gaining a right of first refusal for additional developmental-stage products and territories. Hylenex is a local formulation of recombinant human hyaluronidase being developed for use as a spreading agent to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement. Halozyme filed a new drug application in March, and will be filing for regulatory approval in the European Union.
Hana Biosciences Inc., of South San Francisco, was awarded a $159,000 Small Business Innovation Research grant by the National Institutes of Health in Bethesda, Md. The award will enable Hana to expand preclinical studies of Talotrexin in combination with other therapeutic agents as a potential first-in-class therapeutic approach to treating various forms of cancer, it said.
Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, obtained feedback from the FDA regarding the clinical development of its lead compound, IPL51,602, for asthma, including the prospective use of patient-reported outcomes such as quality of life or symptom scores, as primary endpoints for Phase III studies. The company is moving the compound toward a Phase IIb study, set to begin during the first quarter of 2006.
InNexus Biotechnology Inc., of Vancouver, British Columbia, negotiated a private placement led by SDS Capital Group SPC Ltd. as a principle investor. The financing will support the continued development of the company's SuperAntibody and TransMab technologies. Terms call for InNexus to issue 25,000 convertible preferred shares at a price of $100 per share for total gross proceeds of $2.5 million, with the shares to be convertible at the holder's option for a period of five years from the closing date into units comprised of 400 common shares and 400 warrants.
Large Scale Biology Corp., of Vacaville, Calif., entered a three-year private equity agreement with Brittany Capital Management Ltd., a Southridge Capital Management LLC advised fund, allowing the company, from time to time, to sell up to $15 million. Proceeds of the sales are expected to be used for general working capital and for the retirement of certain bridge debt. Terms call for LSBC to periodically put shares to Brittany Capital, for which it will pay LSBC cash at a 7 percent discount to the market price calculated over a 10-day trading period.
Medarex Inc., of Princeton, N.J., and PharmAthene Inc., of Annapolis, Md., said the FDA cleared their investigational new drug application to begin a Phase I trial of Valortim (MDX-1303), a fully human monoclonal antibody targeting the Bacillus anthracis protective antigen. The dose-escalation study is expected to enroll up to 46 healthy volunteers. Its funding is supported in large part by a grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md.
MorphoSys AG, of Martinsried, Germany, said its first therapeutic antibody program with partner Novartis AG, of Basel, Switzerland, generated numerous fully human antibodies, and achieved the first milestone to MorphoSys. The companies formed an alliance in May 2004 to jointly develop antibody-based therapeutic substances against a range of illnesses. As part of the agreement, Novartis acquired an equity stake in MorphoSys worth about |9 million (US$11.1 million).
Nastech Pharmaceuticals Co. Inc., of Bothell, Wash., withdrew its previously announced public offering of 1.5 million shares of common stock under its shelf registration statement. Nastech President and CEO Steven Quay said the company's "present valuation requirements are not met by current market conditions." Nastech, which had intended to use the proceeds for general corporate purposes, including development of its intranasal parathyroid hormone (PTH 1-34) and RNAi programs, had about $52 million in cash, cash equivalents and short-term investments as of June 30.
NexBio Inc., of San Diego, said the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., awarded the company a $6 million Phase II Small Business Innovation Research grant to further test the company's lead drug candidate, Fludase, for the prevention and treatment of influenza. The drug candidate works by preventing all types and strains of influenza virus from entering the airway epithelial cells, including avian influenza as well as parainfluenza viruses.
Nuvelo Inc., of Sunnyvale, Calif., said Phase I data published in this month's issue of the Journal of Vascular and Interventional Radiology showed that alfimeprase was generally well tolerated with no bleeding complications in patients with chronic peripheral arterial occlusion. Plasminogen and fibrinogen levels remained unchanged, further evidence that alfimeprase acts directly, independent of the plasminogen-plasmin system. There was a dose-dependent consumption of alpha-2 macroglobulin, the protein that rapidly inactivates alfimeprase once it enters the systemic circulation.
OSI Pharmaceuticals Inc., of Melville, N.Y., said the Oncologic Drugs Advisory Committee panel will review at its Sept. 13 meeting the use of Tarceva (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment. The FDA accepted the supplemental new drug application in July, and, based on priority-review status, has until Nov. 2 to take action. Tarceva was approved in November 2004 in locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., initiated a Phase I study of Tarvacin, the company's first anti-phospholipid therapy candidate. The study is an open-label, dose-escalation trial in up to 32 adult patients with chronic hepatitis C infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy.
Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said the first patients have completed treatment in its Phase I trial of PV-10, also known as Provecta. PV-10 is the company's lead cancer agent that is being evaluated for safety and preliminary efficacy in 20 subjects with Stage III metastatic melanoma.
TorreyPines Therapeutics Inc., of San Diego, initiated a Phase I trial of NGX267 for the treatment of Alzheimer's disease. In preclinical models, NGX267 has shown potential as a therapy for symptomatic improvement and disease modification in Alzheimer's disease. NGX267 is a muscarinic or M1 receptor agonist.
Xenova Group plc, of Slough, UK, said a majority of its shareholders approved the company's proposed acquisition by private equity business Celtic Pharma Development UK plc. Board members agreed in June to a buyout for up to £26.1 million (US$47.5 million), after reaching terms on the offer concurrent with a licensing deal between the companies for two Xenova products. (See BioWorld Today, June 27, 2005.)