Aastrom Biosciences Inc., of Ann Arbor, Mich., said that it has expanded the Phase I/II trial of its adult stem cell-based tissue repair cells in the treatment of severe long bone or non-union fractures to include the University of Nebraska Medical Center in Omaha.
Adams Respiratory Therapeutics Inc., of Chester, N.J., priced its initial public offering of nearly 8 million shares at $17 each, raising gross proceeds of about $135.2 million. Of the shares being sold, 5.7 million come from Adams, while 2.25 million come from certain selling stockholders. The underwriters, Merrill Lynch & Co., Morgan Stanley, Deutsche Bank Securities and RBC Capital Markets, have an overallotment option for about 1.2 million shares. The company's stock will trade on the Nasdaq National Market under the symbol "ARXT." Adams plans to use net proceeds to build its Mucinex brand, to fund product development and for potential acquisitions and product in-licensing.
Adherex Technologies Inc., of Research Triangle Park, N.C., said it completed its previously announced private placement, raising gross proceeds of $8.5 million in connection with a licensing and development agreement with London-based GlaxoSmithKline plc, which invested $3 million. Proceeds will fund the company's operations and research and development programs. (See BioWorld Today, July 18, 2005.)
Affymetrix Inc., of Santa Clara, Calif., said the Broad Institute of MIT and Harvard will use the company's GeneChip Mapping 500K Set for genome-wide association studies in the areas of cancer, cardiovascular, metabolic and neuropsychiatric diseases. The institute will work with its collaborators to generate more than 6 billion individual genotypes from 12,000 human DNA samples.
Agilix Corp., of New Haven, Conn., granted Protana Inc., of Toronto, a nonexclusive license to its i-PROT proteomics technology for use in Protana's proteomic services, including biomarker discovery. The technology is a set of isobaric labels that are attached to proteins so they can be quantified or analyzed using mass spectrometry. Terms were not disclosed.
Alexza Molecular Delivery Corp., of Palo Alto, Calif., changed its name to Alexza Pharmaceuticals Inc. to reflect its transition from a research-focused organization to a development stage company with the advancement of its product candidates into clinical trials. Late last year, the company completed a Phase I study with AZ-001, and has begun a Phase IIa study in migraine headaches. A second candidate, AZ-002, is in Phase I.
Alfacell Corp., of Bloomfield, N.J., signed a material transfer agreement with The Novartis Institute for Tropical Diseases (NITD), of Singapore, for the company's ribonuclease antiviral drug candidate, AC 03-636. NITD receives rights to conduct in vitro tests using cell-based assays to evaluate the activity of AC 03-636 in Dengue fever, with in vivo studies in animal models to follow. Alfacell will provide technical assistance for all studies to be conducted by NITD.
Altor BioScience Corp., of Miramar, Fla., received a Phase I Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md., to support development of its processes for making therapeutic antibodies in transgenic lettuce. The application was submitted in response to President Bush's executive order encouraging innovation in manufacturing related research and development. Altor said its long-term goal in the project is to use its plant expression system to produce immunotherapeutic drugs at low manufacturing costs.
Aphton Corp., of Philadelphia, reported the enrollment of its first patient in a newly initiated open-label Phase I/II trial of IGN311. IGN311 is a humanized monoclonal antibody targeting the Lewis Y tumor-associated antigen, which is expressed in up to 90 percent of all epithelial cancers. The endpoints are to evaluate the ability of IGN311 to effectively reduce the number of Lewis-Y positive tumor cells and to decrease the volume of pleural effusions or ascites, in patients with epithelial cancers. The study is intended to enroll up to 24 patients.
APT Pharmaceuticals Inc., of Tucson, Ariz., closed its $6 million Series A round, led by new investor Charter Life Sciences, of Palo Alto, Calif., and existing investor Research Corp. Technologies, of Tucson. Proceeds will fund the initial Phase II trial of its lead compound, an inhaled version of hydroxychloroquine (HCQ) for the treatment of asthma. APT and partner Hayward, Calif.-based Aradigm Corp. advanced the HCQ program into Phase II, with Aradigm responsible for sourcing the active pharmaceutical ingredient, conducting formulation development and handling manufacturing and clinical development.
BioAlliance Pharma SA, of Paris, submitted an investigational new drug application to conduct a pivotal Phase III trial of its antifungal agent, miconazole Lauriad, a once-daily 50-mg extended-release bioadhesive buccal tablet in development as a first-line local treatment for oropharyngeal candidiasis. Pending clearance by the FDA, the company plans to begin the trial in HIV patients during the fourth quarter of 2005.
Biosignal Ltd., of Sydney, Australia, and Q.Stat Pty. Ltd., of Melbourne, Australia, demonstrated in initial testing that Biosignal's anti-biofilm compounds are effective in preventing biofilm formation and corrosion of metals caused by sulphur-reducing bacteria and fungi.
Cardiome Pharma Corp., of Vancouver, British Columbia, completed patient enrollment in its second pivotal Phase III atrial fibrillation trial, ACT 3. The study is being conducted by partner Astellas Pharma US Inc., of Deerfield, Ill., to evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia. The primary endpoint is acute conversion of atrial fibrillation to normal heart rhythm.
ChemDiv Inc., of San Diego, extended its collaboration with Palm Beach County-based Scripps Florida, which gains access to the screening libraries designed by ChemDiv. The company also is offering synthetic, medicinal chemistry, as well as its global logistics services, for researchers at Scripps Florida. Financial details were not disclosed.
Corgentech Inc., of South San Francisco, has begun treating patients in its multicenter Phase I/II trial of its NF-kappaB Decoy drug candidate for the treatment of atopic dermatitis. The 120-patient trial is the second of two parallel Phase I/II trials to be initiated. The trial is a multicenter, randomized, double-blind study. NF-kB Decoy is an inhibitor of the transcription factor, NF-kB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease.
CytRx Corp., of Los Angeles, said it has been in communication with the FDA regarding the investigational new drug application for a Phase II trial of the orphan drug arimoclomol to treat amyotrophic lateral sclerosis. The FDA has placed the trial on clinical hold pending review of information that CytRx has been asked to provide. The trial is designed to investigate the safety and tolerability of arimoclomol in ALS patients.
Evotec AG, of Hamburg, Germany, and Almirall Prodesfarma SA, of Barcelona, Spain, entered a two-year library synthesis agreement. Evotec will design and synthesize for Almirall several thousand drug-like compounds across a range of chemical templates.
Introgen Therapeutics Inc., of Austin, Texas, said its researchers, along with collaborators at the University of Texas M.D. Anderson Cancer Center, published new findings on the role of IL-24 in regulating the immune system in the current online issue of the Journal of Leukocyte Biology that indicate that the expression of IL-24 is increased by greater than 10,000-fold in specific cells that regulate the immune response. Introgen's INGN 241, an investigational therapy in Phase II for the treatment of malignant melanoma, is designed to stimulate the immune system to attack cancer cells through IL-24 dependent mechanisms.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis division was granted contracts for about $5 million from several government agencies, such as the Defense Advanced Research Projects Agency and the Department of Homeland Security, to continue the development of applications and to support the initial operations of the TIGER (Triangulation Identification for Genetic Evaluation of Risks) biosensor system. The system is designed to identify thousands of infectious organisms without having to know what might be present in a sample.
Mesoblast Ltd., of Melbourne, Australia, said it entered an agreement with Colorado State University to perform preclinical dose-escalation trials of its universal donor adult stem cell technology for the treatment of long bone fractures, and for intervertebral spinal fusion. The trials are expected to begin before the end of August, with the first results to be available within five months of initiation.
Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., initiated the first clinical study for its vaccine being developed to prevent Staphylococcus aureus type 336 infections in at-risk patients. The type 336 study is a double-blinded, placebo-controlled study to evaluate safety and antibody responses of the vaccine in up to 48 patients at four different dosage levels.
NanoBio Corp., of Ann Arbor, Mich., completed its Phase II study of NB-001 in patients with herpes labialis and has plans to start Phase III trials next year. NB-001 is a topical emulsion comprised of nanometer-size water/oil droplets coated with a surfactant that has demonstrated antiviral, antibacterial and antifungal activity in previous studies. The Phase II study enrolled 332 patients. There were no drug-related adverse events, reports of drug-induced skin irritation or drop-outs due to adverse events.
Newron Pharmaceuticals SpA, of Milan, Italy, completed patient enrollment in its Phase III trial with safinamide to treat Parkinson's disease. A total of 260 patients in 26 centers worldwide have been randomized in the study, which aims to show safety and efficacy of safinamide used as adjunctive treatment to a dopamine agonist in early stage Parkinson's disease patients. Data should be available in the first half of 2006.
NicOx SA, of Sophia Antipolis, France, said several compounds have been selected for further development from the company's agreement with New York-based Pfizer Inc. to develop nitric oxide-donating compounds for ophthalmology. Those compounds, submitted by NicOx, will be tested by Pfizer to identify a possible candidate for clinical development. The companies signed the agreement in August 2004, with Pfizer receiving the option to obtain an exclusive worldwide license to the compounds. NicOx has received \2 million (U.S. $2.4 million) so far, and stands to receive a further \35 million, plus royalties if the collaboration results in a commercialized product.
Oscient Pharmaceuticals Corp., of Waltham, Mass., said David Stone, board member since 2001, will succeed David Singer as chairman, effective immediately. Singer, who became chairman in 2004 when the merger of Genome Therapeutics Corp. and GeneSoft Pharmaceuticals Inc. created Oscient, will remain a member of the company's board. Stone covered the biotechnology sector from 1989 to 1999 as an analyst at Cowen & Co. Since 2000, Stone has been a partner at Flagship Ventures.
OSI Pharmaceuticals Inc., of Melville, N.Y., said it has initiated a Phase I trial of PSN357. Discovered by Prosidion, OSI's diabetes and obesity team, PSN357 is a glycogen phophorylase inhibitor, which is designed to rapidly lower blood glucose levels by preventing glycogen breakdown to glucose in the liver.
Pain Therapeutics Inc., of South San Francisco, said four peer-reviewed journals and an academic review book are publishing new data that further demonstrate how ultra-low-dose opioid antagonists suppress undesirable effects of opioid therapy. Data show that the antagonists can enhance analgesia, suppress tolerance and physical dependence effects of opioid therapy, and reduce the addictive properties of the drugs. The company's drug Oxytrex is a painkiller that combines an opioid antagonist, like naltrexone, with an opioid agonist, like oxycodone.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., signed a cooperative research and development agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to evaluate the therapeutic application of Tarvacin to treat hemorrhagic diseases resulting from Ebola and Marburg viral infections. Peregrine will supply Tarvacin, its lead anti-phospholipid therapy agent, for in vitro and in vivo animal studies conducted by the USAMRIID.
Perlegen Sciences Japan KK, of Tokyo, and RIKEN (The Institute of Physical and Chemical Research) in Japan formed a high-throughput research collaboration using technology from Santa Clara, Calif.-based Affymetrix Inc. to conduct whole genome association studies aimed at identifying the genetic causes of up to 47 diseases. Perlegen will work with RIKEN's SNP Research Center to conduct first-pass genome scanning of patients to identify regions of the genome associated with many diseases.
Pfizer Inc., of New York, said it plans to file its new drug application to the FDA in August for Sutent (sunitinib malate) for metastatic renal cell and gastrointestinal stromal cancer indications. The drug's data demonstrates a time to progression of 8.7 months. While potential competitor sorafenib had less severe side effects, the partial response rates were much higher with Sutent: 40 percent vs. 2 percent for sorafenib. Emeryville, Calif.-based Onyx Pharmaceuticals Inc. and Bayer Pharmaceuticals Corp., of West Haven, Conn., filed the NDA for sorafenib earlier this month. (See BioWorld Today, July 12, 2005.)
Provectus Pharmaceuticals Inc., of Knoxville, Tenn., obtained final clearance to begin the first Phase I trial in New South Wales, Australia, of PV-10, the company's lead cancer treatment. The study is designed to evaluate the safety and preliminary efficacy of PV-10 in 20 subjects with Stage III metastatic melanoma. PV-10 will be injected into one to three tumors in each patient.
Rigel Pharmaceuticals Inc., of South San Francisco, closed its public offering of 4.2 million shares of common stock, including 547,500 issued to cover overallotments, at a price of $20.75 each for net proceeds of about $81.9 million. Proceeds are expected to fund research and development, as well as general corporate purposes. (See BioWorld Today, July 18, 2005.)
Rubicon Genomics Inc., of Ann Arbor, Mich., formed an agreement with the Genome Institute of Singapore (GIS) to use Rubicon molecular diagnostics technology to recover genetic information from clinical serum samples for a large study of the immune response to vaccination against the hepatitis B virus. Rubicon will isolate and amplify very small amounts of genomic DNA in archived serum samples from 5,000 participants in a hepatitis B vaccine trial. Later this year, GIS will use the DNA in an international study in Indonesia and the Netherlands to discover genes important for hepatitis B prevention and treatment.
Sanofi Pasteur, of Swiftwater, Pa., the vaccines business of the Sanofi-Aventis Group, said work officially began on its new manufacturing facility, which will expand the ability of the U.S. to produce influenza vaccine for routine immunization and in case of a global pandemic. Pennsylvania Gov. Edward Rendell joined company executives and other officials in breaking ground for the new 145,000 square-foot, $150 million manufacturing plant in Swiftwater. It should be ready for production for the 2009 influenza season.
Transgene SA, of Strasbourg, France, said Merck & Co. Inc., of Whitehouse Station, N.J., met a clinical development milestone for a vaccine candidate constructed with Transgene's homologous recombination technology. The technology enables the efficient and fast generation of recombinant viral vectors, in particular adenovirus vectors, which can be used in recombinant vaccines and in vitro diagnostics, among other applications. The parties entered the nonexclusive license for this technology in January 2003.
Viral Genetics Inc., of Azusa, Calif., said it completed enrollment for the eight-week, 16-injection treatment phase of the ongoing Phase III South African study of VGV-1 in HIV. The trial is evaluating VGV-1 in 137 patients with Stage CDC-2 HIV, known as the stage before full-blown AIDS, to monitor its safety, efficacy and immunological function. An interim safety analysis will be conducted next month, and a follow-up phase will conclude in late 2005, with results expected in early 2006.