Active Pass Pharmaceuticals Inc., of Vancouver, British Columbia, and NeoGenesis Pharmaceuticals Inc., of Cambridge, Mass., entered a two-year collaborative agreement to discover and develop drugs to target proteins called ABC transporters, which are implicated in age-related macular degeneration, lipid disorders, Type II diabetes and Alzheimer’s disease. Active Pass will supply ABC transporter targets, and NeoGenesis will apply its Automated Ligand Identification System to discover lead molecules. The companies will then use the NeoGenesis Rapid Ligand Optimization platform and Active Pass biological assays to develop candidates for clinical development. The companies will share ownership of resulting compounds.
Amgen Inc., of Thousand Oaks, Calif., said new data presented at the National Kidney Foundation’s annual clinical nephrology meeting in Chicago continue to show Aranesp’s ability to correct anemia and improve quality of life for chronic kidney disease patients. Data from an Australian study showed Aranesp dosed once monthly maintained hemoglobin in 83 percent of dialysis patients, while 91 percent of those receiving the drug once every three weeks maintained hemoglobin levels. A U.S. study showed that treatment with Aranesp improved health-related quality of life, and another U.S. study showed every-other-week, de novo administered Aranesp effectively maintained hemoglobin in early stage patients.
BioMedicines Inc., of Emeryville, Calif., completed enrollment in its Phase II trial of naturally occurring omega interferon in patients with chronic hepatitis C. The 90-patient study will evaluate escalating doses of omega interferon.
Ceregene Inc., of San Diego, which focuses on gene therapies for neurological disorders, moved into a newly constructed, 20,000-square-foot facility. Ceregene was launched in January 2001 and is a majority-owned subsidiary of Cell Genesys Inc., of Foster City, Calif.
Gilead Sciences Inc., of Foster City, Calif., announced 48-week data from a Phase III trial (Study 438) of its once-daily, oral antiviral agent, adefovir dipivoxil 10 mg, designed to treat patients with chronic hepatitis B. Study results show that 48 weeks of treatment with adefovir dipivoxil was associated with improved liver histology and reduced serum hepatitis B virus DNA concentrations in patients infected with the precore mutant strain of the virus. Also, serum HBV DNA concentrations were reduced to below the limit of detection in more than half of patients. The data were presented at the 37th annual meeting of the European Association for the Study of the Liver in Madrid, Spain. Adefovir dipivoxil is a nucleotide analogue designed to work by blocking HBV DNA polymerase. Separately, the company said it also presented at the meeting data from a single-center, open-label clinical trial called Study 460i. The data showed that adefovir dipivoxil was associated with sustained reductions in levels of HBV DNA through 92 weeks in chronic hepatitis B patients with lamivudine-resistant HBV and co-infected with HIV.
Guilford Pharmaceuticals Inc., of Baltimore, completed a Phase I study of Aquavan injection administered by bolus injection. Preliminary results of the 24-volunteer study suggest that rapid bolus administration of Aquavan safely produces loss of consciousness at a similar time as an equipotent infusion of propofol, and produces a longer duration of effect. The study was designed to evaluate the safety, pharmacokinetic and pharmacodynamic properties of propofol derived from Aquavan injection, compared to Diprivan injectable emulsion.
Hemispherx Biopharma Inc., of Philadelphia, and the AIDS Community Research Initiative of America initiated clinical trials, called AMP 719 and AMP 720, involving the application of Hemispherx’s Ampligen to the treatment of HIV/AIDS. AMP 720 will study whether Ampligen can assist the immune system’s response to an interruption of highly active anti-retroviral treatments (HAART). AMP 719 will study whether Ampligen can resensitize the immune system to certain of the HAART or cocktail regimens to which it has become desensitized through drug resistance.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., completed the sale of 26 million shares of its subsidiary, Ribapharm Inc., of Costa Mesa, Calif., pursuant to a $260 million public offering this week. ICN also accepted for payment all of the company’s 8 percent Series B senior notes due 2008 pursuant to its previously announced tender offer and consent solicitation. The tender offer expired Wednesday. (See BioWorld Today, April 15, 2002.)
Inhibitex Inc., of Atlanta, completed a $45 million Series D financing. The company said in February it raised $41.4 million through a first closing. Burrill & Co., of San Francisco, a new investor, and William Blair Capital Partners, of Chicago, an existing investor, provided the remaining $3.6 million. Inhibitex has raised a total of $65 million in private equity to date. (See BioWorld Today, Feb. 12, 2002.)
Introgen Therapeutics Inc., of Austin, Texas, said a preclinical study published in Cancer Research may help explain why INGN 241, an adenoviral vector encoding the melanoma differentiation association-7 (mda-7) gene, works effectively as a tumor suppressor against a range of cancers. Researchers identified a particular protein kinase gene, known as PKR, as playing a crucial role in facilitating the ability of INGN 241 to interfere with tumor development and induce programmed cell death. When cancer cells were treated with a chemical inhibitor of PKR, no apoptosis occurred after INGN 241 treatment.
Molecular Staging Inc., of New Haven, Conn., reported the publication of a paper in this month’s issue of Nature Biotechnology that describes a new approach to analyzing multiple proteins simultaneously on a glass chip microarray. The paper describes a chip-based proteomics discovery platform that employs RCAT to amplify signals from proteins in a highly multiplexed format, which the company calls the first effective protein chip to measure 80 proteins simultaneously in a human sample.
Ligand Pharmaceuticals Inc., of San Diego, said a Phase III trial of Ontak (denileukin diftitox) showed that patients with advanced or recurrent cutaneous T-cell lymphoma (CTCL) who responded to Ontak treatment also experienced significant quality-of-life improvements. Data were published in the March issue of Clinical Lymphoma. In the 71-patient study, 21 patients (30 percent) responded to Ontak therapy, as measured by absence of disease or a greater than 50 percent reduction in tumor burden that was sustained for six weeks or more. Among responders, composite questionnaire and most individual subscores gradually increased, generally reaching statistical significance by the third treatment cycle.
Maxim Pharmaceuticals Inc., of San Diego, presented preclinical results at the European Association for the Study of the Liver conference in Madrid, Spain, showing that Ceplene (histamine dihydrochloride) protected against alcohol-induced liver injury in an animal model. Animals administered the same dose of ethanol but treated with Ceplene had livers comparable in appearance to the control group, and had normal ALT and AST levels (p<0.05). Animals treated with Ceplene also had statistically significant better scores (p<0.05) for inflammation, necrosis and total pathology compared to the untreated group.
NewBiotics Inc., of San Diego, said an article published in the May issue of the journal Antimicrobial Agents and Chemotherapy demonstrated proof of principle of its “Trojan Horse” technology to destroy drug-resistant bacteria using the pathogen’s own resistance enzyme to release a toxin hidden within a drug. NewBiotics scientists tested antibacterial activity of NB2001 against 300 clinical isolates of Gram-negative and Gram-positive bacteria. The compound had activity against nearly all beta-lactamase-producing strains, including major human pathogens significant in drug-resistant hospital-acquired infections such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecalis, the company said.
Nonlinear Dynamics Ltd., of Newcastle upon Tyne, UK, was awarded a Department of Trade and Industry Smart Exceptional Development award worth about $630,000. The 19-month award funds a research-based project for the development of Progenera, a bioinformatics data engine with distributed computing technology to offer high-throughput data analysis management and mining solutions.
Oncolytics Biotech Inc., of Calgary, Alberta, reported results from a study of Reolysin in canines with naturally occurring cancers. The study entailed three injections of Reolysin administered on alternating days directly into a subcutaneous malignant tumor in 17 canines. In six of 15 evaluable canines, the tumors were classified as stable disease (five) or partial responses (one) on day 32 after the first injection. Sixty percent of post-treatment biopsies from tumor masses showed increased cell death. Two of the tumors appeared to be completely replaced by noncancerous cells and fibrous tissues and another four cases had evidence of cell death in at least 75 percent of the biopsy sample. There were no serious adverse reactions.
Orchid BioSciences Inc., of Princeton, N.J., decided to take certain actions intended to reduce operating expenses and accelerate expected profitability to the latter part of 2003. Orchid said it will eliminate about 90 positions, or about 15 percent of the company’s total staff, and is transferring most of its manufacturing and production operations from Princeton to its accredited facilities in Dayton, Ohio, and Stamford, Conn. A number of facilities also will be closed. The staff reductions are being made across all of Orchid’s strategic business units, but are higher in Orchid Life Sciences, reflecting the completion of research and development and product development projects, as well as a refocusing of marketing efforts to Orchid’s breakthrough SNPstream UHT system.
Qiagen NV, of Venlo, the Netherlands, completed the acquisition of Xeragon Inc., of Huntsville, Ala. The acquisition adds to Qiagen’s position in synthetic DNA products. Qiagen issued approximately 564,000 shares of its stock, valued at about US$8 million, in exchange for all of the outstanding stock of Xeragon. Qiagen also could make an additional payment of up to US$1.2 million in cash or stock in December 2003 upon the attainment of certain performance targets.
Repligen Corp., of Needham, Mass., received Medicines Control Agency approval to conduct a trial in the UK to assess the safety and efficacy of CTLA4-Ig in patients with refractory autoimmune thrombocytopenic purpura. A total of 12 patients with ITP will be treated in a Phase I/II open-label, dose-escalating trial. CTLA4 is a T-cell regulatory protein.
Structural Bioinformatics Inc., of San Diego, expanded its research collaboration with Johnson & Johnson Pharmaceutical Research & Development LLC, of La Jolla, Calif. The collaboration was initiated in January 2001. SBI will expand its structural proteomics services in support of PRD’s drug discovery programs using X-ray crystallography and drug-protein co-crystallization technologies for PRD proprietary compounds. Financial terms were not disclosed.
SurroMed Inc., of Mountain View, Calif., received an equity investment from PPD Inc., of Wilmington, N.C. SurroMed focuses on phenotyping and biological marker discovery technologies. SurroMed’s biomarker technology is useful in stratifying patients by disease type and response to therapy, as well as identifying and validating therapeutic and diagnostic targets. Financial terms were not disclosed.
Teva Neuroscience Inc., a unit of Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel, reported at the American Academy of Neurology conference in Denver the majority of patients treated with Copaxone remained either unchanged or improved in their neurologic status during an eight-year period of a 12-year, randomized, double-blind, placebo-controlled multiple sclerosis drug trial. The placebo-controlled phase lasted about 30 months. Patients who received placebo at the beginning of the study were more likely to have worsened by more than one step on the Expanded Disability Status Scale (p=0.0263). In addition, the relapse rate across the entire eight years was significantly better for patients always on Copaxone than those who began on placebo (p=0.0459).
Titan Pharmaceuticals Inc., of South San Francisco, reported at the American Academy of Neurology conference in Denver that treatment with Spheramine produced a nearly 50 percent improvement in motor function in patients with advanced Parkinson’s disease in a recently completed, 12-month Phase I/II study. Spheramine is a cell therapy product being developed by Titan in collaboration with Schering AG, of Berlin. The open-label, six-patient study also demonstrated significant improvement in quality of life for all patients, with no significant adverse events. Titan and Schering plan to begin a randomized clinical study of Spheramine.
TransMolecular Inc., of Birmingham, Ala., received a Phase II Small Business Innovation Research grant worth approximately $760,000 to discover and develop pharmaceutical alternatives for treating neuropathic pain over the next two years. TransMolecular exclusively licensed from Yale University a new sodium ion channel mined from the central nervous system that produces abnormal repetitive neuronal firing, an underlying cause of neuropathic pain.
Viragen Inc., of Plantation, Fla., completed new equity financing arrangements, and said it would release terms within two weeks. The agreement includes Viragen’s right to draw down funds in amounts and at such times that it considers most beneficial. Viragen plans to use the financing to fund its commercial programs and research and development projects.