A.P. Pharma Inc., of Redwood City, Calif., said it completed its initial Phase I study with APF 112, its product for the treatment of post-surgical pain. Results indicated that APF 112 caused no adverse events in 16 subjects. The company said it is finalizing its protocol for a Phase Ib study and expects to finalize a Phase II study protocol by midyear. APF 112 incorporates mepivacaine, a local anesthetic with analgesic properties.
Alexion Pharmaceuticals Inc., of Cheshire, Conn., began its first Phase IIb trial in rheumatoid arthritis patients with its humanized monoclonal antibody C5 complement inhibitor, 5G1.1. The trial is designed to assess the safety and efficacy of 5G1.1 and to confirm the most efficacious dose regimen of the drug. The trial will consist of about 300 patients who are being treated concomitantly with moderate doses of methotrexate or leflunomide. The trial will consist of three treatment arms. Patients will be treated with placebo; 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks and then once every month; or 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks and then once every two weeks. The patients will be evaluated after six months, with the primary endpoint being the ACR20 score.
Alfacell Corp., of Bloomfield, N.J., reported results of a new collaboration with Martin Michaelis at the Institute of Medicinal Virology at Johann Wolfgang University in Frankfurt, Germany, which focuses on the use of Onconase, an anticancer drug to treat various forms of childhood soft tissue and muscle cancer. Results of in vitro studies reveal significant antitumor activity of Onconase against neuroblastoma, rhabdomyosarcoma and chemotherapy-resistant variants of the same cell lines. Onconase, a new class of ribonuclease drug, is active even in cell lines where traditional chemotherapy has failed, the company said.
Arcturus Engineering Inc., of Mountain View, Calif., introduced five new Cellex Mouse Neuron cDNAs, providing help for gene expression or discovery studies of the mouse brain. PCR of cDNA from specific neuron subtypes affords higher resolution than that of whole biopsies or brain regions. The five PCR-ready cDNAs are derived from fronto/parietal motor cortex neurons and four hippocampal neuron subtypes: CA1/CA2, CA3, dentate gyrus and subiculum. Arcturus provides systems for microgenomics that allow researchers to prepare pure cell populations from tissue and extract nucleic acids and proteins from captured cells.
BD Biosciences, of San Jose, Calif., a business segment of Becton, Dickinson and Co., entered into a collaboration with the Harvard Institute of Proteomics at Harvard Medical School in Cambridge, Mass., to generate thousands of gene clones involved in biological processes. Harvard scientists will use the BD Creator gene cloning and expression system to clone the genes. BD Biosciences will retain commercial rights to the resulting cloned genes. BD Biosciences will support the proteomics program. Additional terms were not disclosed.
Cellomics Inc., of Pittsburgh, said it is taking “action to drive the company toward profitability” by year’s end or early 2003. Those actions include canceling some projects following a review of the organization’s operations and activities, as well as eliminating 50 positions, the company said. Cellomics focuses on cellular-knowledge extraction and said it is the first to integrate fluorescent reagents, kits, cell lines, multiparametic assays and HCS instruments, informatics and cellular bioinformatics.
Connetics Corp., of Palo Alto, Calif., said results from its Phase IV trial of Olux (clobetasol propionate) foam for mild-to-moderate non-scalp psoriasis will be presented today at the 26th annual Hawaii Dermatology Seminar. The 279-patient, placebo-controlled, randomized, double-blind study was conducted at 17 clinical centers. Patients received either Olux or placebo twice daily for 14 days and were evaluated using the Physician’s Static Global Assessment score as the primary endpoint. Of those patients treated with Olux, 71 percent had complete or almost complete clearance of disease, compared with 22 percent treated with placebo.
Corcept Therapeutics Inc., of Menlo Park, Calif., set the range for its initial public offering at $14 to $16 per share and its number of shares at 4.5 million. At those figures, the offering would raise between $63 million and $72 million. The company filed for the offering on Dec. 21, 2001. It focuses on the development of drugs for the treatment of severe psychiatric and neurological diseases. (See BioWorld Today, Dec. 28, 2001.)
Demegen Inc., of Pittsburgh, said it is reducing operating costs to conserve cash flow until new funding can be obtained from investors or partners for licensing or development. The company said it would actively seek co-development partners and expects to announce a development partnership for the D2A21 infected burn/wound gel in the near future. Also, it said grants and other sources should allow Demegen to sustain operations. However, until new funding is secured, clinical programs will proceed slowly, the company said.
Epimmune Inc., of San Diego, provided an update on its initial HIV vaccine candidate, including clinical trial plans. Because additional time is necessary to complete all animal safety studies outlined in its pre-investigational new drug application discussions with the FDA, it plans to file an IND for its initial vaccine during the second quarter. Clinical trials could begin about one month after the filing of the IND, pending FDA review.
Hemosol Inc., of Toronto, demonstrated in a preclinical study that HRC-102, a conjugate of o-raffinose-polymerized hemoglobin and a soluble vitamin E analogue with broad antioxidant properties, may have special application in the treatment of reperfusion injury. These findings were presented at the second annual winter symposium of the American Society of Transplant Surgeons in Miami.
Human Genome Sciences Inc., of Rockville, Md., said that results from the its Phase IIa trial of repifermin (keratinocyte growth factor-2, or KGF-2) as a treatment for chronic venous ulcers appear in the current issue of Wound Repair and Regeneration. In the 15-center, randomized, double-blind, placebo-controlled trial, Repifermin was shown to accelerate wound healing, with significantly more patients achieving 75 percent wound closure within the 12-week duration. The safety assessment of the 94-patient study showed that repifermin was well tolerated.
Illumina Inc., of San Diego, signed a commercial agreement with investigators at Boston University Medical Center to provide single nucleotide polymorphism genotyping services for a large-scale research project on preterm birth. Illumina will use its BeadArray technology to score a set of SNPs thought to be associated with preterm birth. Illumina also will design SNP assays for the SNP loci provided by the investigators. Further details were not disclosed.
Inspire Pharmaceuticals Inc., of Durham, N.C., said that in order to maintain focus on its top priorities, it will reduce its 2002 operating budget by 25 percent. No layoffs of existing staff are expected for the budget reduction. It has put on hold its plans to re-initiate in 2002 the Phase II study for INS365 respiratory in chronic bronchitis, as well as plans to submit an investigational new drug application in 2002 for atrophic vaginitis. Based on the recently reported negative Phase III dry eye study results, the company will refocus efforts on four of its six clinical programs in the ophthalmology and respiratory areas. The programs of primary focus are those for dry eye, lung cancer diagnosis, rhinosinusitis and cystic fibrosis. Inspire’s top priority continues to be the further evaluation of data from the first of two Phase III studies for INS365 ophthalmic for dry eye, and the development of appropriate next steps for the program. Results of the second Phase III trial are expected in the second quarter. (See BioWorld Today, Jan. 17, 2002.)
ISTA Pharmaceuticals Inc., of Irvine, Calif., provided an update regarding the unmasking of data from its Phase III trials of Vitrase, its product for the treatment of severe vitreous hemorrhage. The company said it is in the process of securing final FDA agreement of its statistical analysis plan for the Vitrase Phase III studies before analyzing the results. The news was released after the market closed on Monday. ISTA’s stock (NASDAQ:ISTA) fell 53 cents Tuesday, or about 13.3 percent, to end the day at $3.47.
Keryx Biopharmaceuticals Inc., of Cambridge, Mass., received approval from the South African Medicines Control Council for the initiation of a Phase II trial of KRX-101 (sulodexide) for HIV-associated neuropathy. Keryx plans to begin the trial next month and to have results this year. The trial will be a randomized, placebo-controlled, dose-response study and will include about 75 AIDS patients with HIV-associated neuropathy. KRX-101 will be studied for its ability to diminish the rates of increase of serum creatinine and proteinuria, two common endpoints for the measurement of kidney function. Keryx also is moving forward to initiate a Phase III trial in the United States of KRX-101 for diabetic nephropathy.
MGI Pharma Inc., of Minneapolis, and MethylGene Inc., of Montreal, began a clinical trial of MG98, a second-generation antisense inhibitor of DNA methyltransferase. This 50-patient trial will assess the safety and pharmacokinetic profiles of MG98, define the optimal effective dose of MG98 in these patients and document both the biological and clinical effects of MG98 in patients with advanced myelodysplasia and relapsed or refractory acute myeloid leukemia. Enrollment is expected to last approximately 12 months. MGI is developing MG98 under an exclusive North American license, research and development agreement for MG98 and other inhibitors of DNA methyltransferase with MethylGene. Phase II trials of MG98 in head and neck cancer and in renal cell carcinoma are ongoing.
Neurobiological Technologies Inc., of Richmond, Calif., said its partner, Merz Pharma KGaA, of Frankfurt, Germany, was honored for its work on antidementia drug Memantine and granted the German Innovation Award 2002. The companies have a strategic and financial relationship with regard to Memantine. The drug is the most prescribed antidementia drug among prescription medicines in Germany. The company called Memantine the first pharmaceutical with proof of efficacy in patients with advanced stages of Alzheimer’s dementia.
Ortec International Inc., of New York, said it received an additional $5 million from Paul Capital Royalty Acquisition Fund, of New York, as part of a $15 million nonequity financing in August 2001. The remaining $5 million would be available to Ortec at its sole option and upon meeting specified milestones. Ortec is a tissue-engineering company. (See BioWorld Today, Aug. 31, 2001.)
Pozen Inc., of Chapel Hill, N.C., said preliminary results of its first carcinogenicity study for its lead product candidate, MT 100, indicate that it is not carcinogenic in the test species, transgenic p53 mice. Results from the ongoing two-year rat study will be available in 2003. MT 100 is being developed as an oral, first-line treatment for migraine pain and associated symptoms, and its effectiveness has been demonstrated in numerous Phase II and Phase III studies involving thousands of patients. It exhibited comparable efficacy with fewer side effects when tested against Imitrex, the worldwide market leader. The FDA set back Pozen last year with the request for the carcinogenicity study. (See BioWorld Today, Jan. 29, 2001.)
Protein Polymer Technologies Inc., of San Diego, received approximately $1 million in additional capital through the exercise of warrants for the purchase of common stock. Some of the proceeds will be used to accelerate clinical testing of its product to treat female stress urinary incontinence. Over the next few months, the company plans to raise additional funds for continuing operations through private or public offerings, and through additional collaborative agreements. Investors were not disclosed.
RLX Technologies Inc., of New York, and Platform Computing Inc., of Tucson, Ariz., entered into an agreement that allows RLX to offer Platform Clusterware as part of the RLX BLAST Cluster Solution. Together the RLX compute platform and Platform Clusterware will facilitate scale-out compute clusters that enable processing of BLAST jobs for bioinformatics customers.