Adherex Technologies Inc., of Research Triangle Park, N.C., said it gave effect to the consolidation of its outstanding share capital on the basis of one new security for every three outstanding securities, reducing the number of outstanding shares from about 29.6 million to about 9.9 million. The cancer drug development firm also filed notice to change its name to Fennec Pharmaceuticals Inc., which it said will better reflect its current business focus and activities, and will trade post-consolidation on the TSX Exchange under the ticker FRX.
Aerpio Therapeutics Inc., of Cincinnati, reported the publication of preclinical data showing that lead candidate AKB-9778 reduced abnormal blood vessel growth and leakage in mouse models of ophthalmic diseases such as diabetic macular edema (DME) and age-related macular degeneration. The company said the findings demonstrated the potential benefit of restoring Tie2 activation in mouse models of vision-robbing eye diseases and supported the benefit of AKB-9778 as monotherapy or an adjunct to anti-VEGF agents. The results also confirmed clinical findings that the drug is safe and well tolerated. The data were published in collaboration with researchers at Johns Hopkins School of Medicine, Max Planck Institute and Duke University in The Journal of Clinical Investigation. AKB-9778 is a small-molecule activator of Tie2 that is being evaluated in a phase II study in DME. (See BioWorld Today, Oct. 5, 2012.)
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the National Institute for Health and Clinical Excellence Evaluation Committee acknowledged that FDA-approved Soliris (eculizumab) is an effective treatment option for patients with atypical hemolytic uremic syndrome, and that the use of eculizumab would be of significant value to patients with the life-threatening disorder who have no other treatment options. (See BioWorld Today, Sept. 25, 2011.)
Biscayne Pharmaceuticals Inc., of Miami, said it was presenting data at the American Society of Clinical Oncology's Breast Cancer Symposium in San Francisco supporting the anticancer potential of its growth hormone-releasing hormone (GHRH) technology. The data, which used specimens from breast cancer patients, suggested that the majority of breast cancers – both primary and metastatic tumors – are GHRH-receptor positive, confirming the validity of GHRH as a potential therapeutic target for breast cancer drugs. Nobel laureate Andrew Schally previously discovered that cells throughout the body, including cancer cells, have receptors for GHRH – which releases growth hormone to manage growth and tissue repair – thereby fueling their own growth. Biscayne licensed rights to Schally's GHRH discoveries and is developing GHRH antagonists that inhibit tumor growth by binding to and blocking the activity of the GHRH receptors on cancer cells.
Chimerix Inc., of Durham, N.C., disclosed in vitro activity of its investigational antiviral brincidofovir (BCV) against the Ebola virus following testing at the Viral Special Pathogens Branch of the Centers for Disease Control and Prevention (CDC) and NIH. Additional assessments of BCV in animal model studies are being conducted through the CDC and NIH, Chimerix said.
Cleveland Biolabs Inc., of Buffalo, N.Y., said the minutes from its meeting with the FDA in July confirmed that the company's existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-emergency use authorization submission for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. The firm is developing the drug, a Toll-like receptor 5 agonist, as a cancer treatment and as a medical countermeasure to reduce the radiation damage to hematopoietic and gastrointestinal tissues. Shares of the company (NASDAQ:CBLI) closed Wednesday at 56 cents, up 16 cents, or 40 percent. (See BioWorld Today, July 30, 2013.)
Halozyme Therapeutics Inc., of San Diego, said the FDA granted fast track designation for Halozyme's program investigating PEGPH20 (pegylated recombinant human hyaluronidase) in combination with gemcitabine and Abraxane (nab-paclitaxel, Celgene Corp.) for the treatment of patients with metastatic pancreatic cancer to demonstrate an improvement in overall survival.
Iroko Pharmaceuticals LLC, of Philadelphia, said it secured favorable decisions from key managed care organizations for inclusion of Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug, on their 2015 national formularies. The FDA approved Zorvolex in October 2013 for the management of mild to moderate acute pain in adults and in August 2014 for the management of osteoarthritis pain.
Palatin Technologies Inc., of Cranbury, N.J., and Gedeon Richter plc, of Budapest, Hungary, signed a collaboration and license agreement to co-develop and commercialize bremelanotide for female sexual dysfunction indications in the European Union, other European countries and additional selected countries. Under the terms, Palatin will receive total up-front payments of €7.5 million (US$9.9 million). Palatin and Richter each will contribute to the European co-development activities (primarily one phase III trial in Europe) for obtaining regulatory approval in Europe. Palatin anticipates that its part of the European co-development activities will be cash-neutral through the European regulatory filing stage. All sales, marketing and commercial activities and associated costs in the licensed territory will be the sole responsibility of Richter. Palatin will also get €2.5 million upon the start of its phase III program in the U.S., and is eligible to receive €20 million in regulatory-related milestone payments, with up to €60 million if sales goals are reached, as well as low double-digit royalties on net sales in the licensed territory. Palatin's stock (NYSE:PTN) closed Wednesday at $1.04, up 13 cents, or 14.8 percent.
Psivida Corp., of Watertown, Mass., said the Swedish Medical Products Agency granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The drug has now been approved in 10 EU countries. Iluvien is currently under review by the FDA with a PDUFA date of Sept. 26.
RegeneRx Biopharmaceuticals Inc., of Rockville, Md., said it received $1 million, representing the last tranche of a $2.5 million product license and securities purchase agreement with Korea-based G-Treebnt Co. Ltd. to develop the company's RGN-259 preservative-free eye drop product candidate in Asia (excluding China, Hong Kong, Taiwan and Macau), and its RGN-137 topical dermal gel product candidate in the U.S. G-Treebnt purchased about 8.3 million shares of common stock at 12 cents each and retains an option until Jan. 31, 2015, to purchase additional common stock for $825,000 at 15 cents per share.
Replicel Life Sciences Inc., of Vancouver, British Columbia, said it joined the Centre for Commercialization of Regenerative Medicine's (CCRM) industry consortium. CCRM is currently engaged in providing the company with contract regulatory services, including documentation and filings related to its RCT-A-01 product for chronic Achilles tendinosis. That program is the subject of a planned trial in Canada that will involve clinical testing to address chronic tendinosis, a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury until there are very few pain-free and functional periods. RCT-A-01 will attempt to address the cellular deficit by providing an injection of a patient's own fibroblasts to the site of the injury.
Sunshine Biopharma Inc., of Montreal, said it is negotiating with several contract research organizations (CROs) with the intent to engage one of them to initiate, compile and manage a regulatory master drug file for Adva-27a, its lead anticancer compound.
Ventirx Pharmaceuticals Inc., of Seattle, inked an agreement with nonprofits Ludwig Cancer Research and the Cancer Research Institute (CRI) to conduct a clinical trial with motolimod (VTX-2337) combined with other immunotherapy agents available to Ludwig and CRI through other industry partnerships. Ventirx will provide motolimod, an immunotherapy agent designed to bind and activate Toll-like receptor 8. Terms of the agreement were not disclosed.
Viiv Healthcare Ltd., of London, said the European Commission granted marketing authorization of Triumeq for the treatment of HIV in adults and adolescents, ages 12 and older, and weighing at least 40 kg. The once-daily pill combining integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine, gained approval in the U.S. last month. Viiv is a joint venture between pharma firms Glaxosmithkline plc, of London, and Pfizer Inc., of New York. (See BioWorld Today, Aug. 25, 2014.)
Zymeworks Inc., of Vancouver, British Columbia, said it entered a master services agreement with contract manufacturer CMC Biologics Inc. for process development, formulation development and cGMP clinical manufacturing of a recombinant human IgG1 bispecific (heterodimeric) antibody. Terms were not disclosed.