• Acell Inc., of Jessup, Md., completed a $6 million financing. Capital raised in the first round of financing will be used for general corporate purposes, including strengthening Acell's position in regenerative medicine-based veterinary products and developing the company's portfolio of medical products.

• Affymetrix Inc., of Santa Clara, Calif., launched its new GeneChip Rate Genome 230 2.0 Array, offering researchers the transcribed rat genome on a single microarray, designed to reduce the labor, time and resources needed for gene expression experiments, the company said. The product represents the largest number of rat transcripts and variants available on a single-expression analysis array, consolidating the data from the previous two-array Rate Expression Set 230.

• Altana AG, of Bad Homburg, Germany, said that new clinical data on its inhaled asthma drug, Alvesco (ciclesonide), and on its intranasal formulation of ciclesonide were presented at the 2004 American Academy of Allergy, Asthma and Immunology's 60th annual meeting in San Francisco. Safety studies with Alvesco showed that lower-leg growth in children was not affected. The data presented for the intranasal formulation of ciclesonide showed a dose response in patients with allergic rhinitis.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, said a new study published this month in Proteomics shows that 2-dimensional difference gel electrophoresis (2-D DIGE) technology provided by Amersham Biosciences reveals statistically significant differences in protein abundance between normal and colorectal cancer samples that would not have been easily detected using classic 2-D gel separation. Using that method, 52 proteins that had a statistically significant difference in abundance between tumor and normal samples were identified.

• Antisoma plc, of London, reported progress Monday on two of its cancer drugs in development. The third and final Phase I study of AS1404 as a monotherapy was completed, providing data required to plan a Phase II program. AS1404 is considered most likely to provide a benefit when used alongside other therapies, the company said. AS1405 started its first trial in patients with glioma. That trial will provide information on safety, dosing and distribution of the drug, as well as evidence of any antitumor activity. Patients included in the study have suffered a relapse of their glioma with regrowth of the tumor after initial treatment.

• Astex Technology Ltd., of Cambridge, UK, said it will collaborate with the Wellcome Trust, the Institute of Cancer Research and Cancer Research Technology, all of London, to discover drugs against the cancer target BRAF. In 2002, scientists from the Institute of Cancer Research and the Cancer Genome Project at the Wellcome Trust Sanger Institute identified BRAF as a key target implicated in a variety of cancers. The gene is involved in up to 70 percent of certain cancer types, including malignant melanoma. The parties began a collaboration in 2003 with Cancer Research Technology to identify BRAF inhibitors. Astex now will provide its knowledge in fragment-based drug discovery. The partners will work together in drug discovery, cancer biology, and the preclinical and clinical development of cancer drugs.

• BioSyntech Inc., of Laval, Quebec, filed for its initial public offering in Canada. The company filed its final prospectus with regulatory authorities in Quebec, Ontario, Manitoba, Alberta and British Columbia for the sale of up to 4 million units at a price of C$1.25 per unit to raise C$5 million (US$3.8 million). Each unit includes one common share and half of one warrant. A first closing has been scheduled for March 29. Canaccord Capital is acting as BioSyntech's agent for the offering. BioSyntech trades on the Over-the-Counter Bulletin Board under the symbol "BSYI."

• Bone Care International Inc., of Middleton, Wis., filed a registration statement with the SEC to offer 4.5 million shares of common stock. The company will offer 4 million of the shares, while a selling shareholder, Richard Mazess, will offer 500,000 shares in the offering. Proceeds will be used for general corporate purposes. Citigroup Inc. is acting as lead manager in the offering. Co-managers are Robert W. Baird & Co.; First Albany Capital Inc.; Adams, Harkness & Hill; and Roth Capital Partners. The underwriters have an option for an additional 675,000 shares to cover overallotments.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., presented previously reported Phase III data at the Skin Disease Education foundation's Phoenix Dermatology Open Seminar, showing that Periostat (doxycyline) was effective in treating rosacea. Treatment with the product resulted in a reduction of inflammatory lesions 76 percent higher than that of the control group. The data were first reported last month. (See BioWorld Today, Feb. 18, 2004.)

• EraGen Biosciences Inc., of Madison, Wis., entered a collaboration with Emory University in Atlanta to develop a quantitative genotyping system useful in the early detection of HIV variants. EraGen will provide Emory with highly sensitive mixed-population quantitative genotyping systems for HIV. In turn, Emory will provide expertise and testing results. The program is supported by a grant from the National Institutes of Health in Bethesda, Md.

• First Horizon Pharmaceutical Corp., of Alpharetta, Ga., said the initial purchasers of $125 million in 1.75 percent senior subordinated contingent convertible notes due 2024 exercised in full their option to buy another $25 million in notes, bringing the total raised to $150 million. The company intends to use proceeds for future acquisitions of products, technologies and business, and for general corporate purposes. First Horizon markets and sells prescription products focusing on cardiology, and women's health and pediatrics.

• Gene Logic Inc., of Gaithersburg, Md., launched the ToxPlus program, a combination of toxicology services, combining the company's toxicogenomics data and services with its traditional preclinical safety and pharmacology studies capabilities. The ToxPlus program was scheduled for introduction at the Society of Toxicology annual meeting in Baltimore that began Sunday and continues through Wednesday.

• Genomics Collaborative Inc. and Whitehead Institute for Biomedical Research, both of Cambridge, Mass., are partnering to examine the human Y chromosome's role in male infertility. Researchers will study a large number of human male DNA samples to uncover Y chromosome variations. They will begin looking at DNA samples from 4,000 U.S. males, and then expand the research to look at 20,000 additional men worldwide. The samples are part of Genomics Collaborative's Global Repository.

• Health Discovery Corp., of Savannah, Ga., signed an agreement with Stanford University to use Health Discovery's Fractal Genomics Modeling techniques to identify new patterns of biomarkers in lymphatic insufficiency and its response to therapeutic lymphangiogenesis. Any invention discovered using Health Discovery's analytical tools on the Stanford database will be jointly owned by both parties.

• Helix BioMedix Inc., of Bothell, Wash., raised $1.1 million in gross proceeds through a private placement of equity. The company, which is developing small proteins for antimicrobial and wound-healing applications, said the funds would ensure that it will continue to execute its business plan through this year.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., began a Phase II study of INKP-102, its advanced-generation sodium phosphate purgative tablet. The multicenter, investigator-blinded trial is designed to compare several dosing regimens of the new tablets against the company's currently marketed Visicol tablets in adults scheduled for colonoscopy. InKine said the FDA has indicated that the study could be supportive of a single pivotal trial. Data are expected in the third quarter of this year. Separately, the company said it was named the defendant in a class-action lawsuit filed on behalf of a putative class of its stockholders who have purportedly been denied certain claimed preemptive rights during the last six years.

• Inpharmatica Ltd., of London, entered an agreement with GlaxoSmithKline plc, of London, allowing GSK to access its ADME (absorption, distribution, metabolism and excretion) technologies. Inpharmatica will apply its in silico ADME technology to an undisclosed number of GSK drug discovery programs in the UK and Europe. The ADME platform provides a framework in which large collections of molecules or chemistry ideas can be ranked and prioritized for progression based upon their likelihood of success.

• Microbix Biosystems Inc., of Toronto, entered an agreement to raise $500,000 in the form of an 8 percent convertible debenture, in a non-arms-length transaction with an existing shareholder. The principal amount of the debenture is convertible into common shares at 90 cents per share for a period of eight years. Proceeds will be used to fund working capital. Microbix specializes in developing and manufacturing biological products.

• MIV Therapeutics Inc., of Vancouver, British Columbia, entered into agreements with certain accredited investors for the sale of stock and stock warrants for gross proceeds of about $2.3 million. The company has sold an aggregate of about 5.2 million shares and issued to the investors Series A warrants, exercisable for five years from the date of issuance, to purchase about 2.6 million shares at an exercise price of 66 cents per share and Series B warrants, exercisable for 180 days from the effective date of the registration statement, to purchase about 1.3 million shares of stock at a price of 75 cents per share. The funds are necessary for completion of the next stage of its research and development program leading toward commercialization of its biocompatible coating technology developed for cardiovascular stents and other medical devices.

• NeoRx Corp., of Seattle, formed an agreement with the University of Missouri-Columbia Research Reactor Center for the manufacture and supply of radioisotope holmium-166 for NeoRx's Phase III trial of STR (Skeletal Targeted Radiotherapy). Within the next few weeks, NeoRx expects to open enrollment in the Phase III trial of STR in primary refractory multiple myeloma. The company uses holmium-166 in the formulation of STR. Financial terms were not disclosed.

• NexMed Inc., of Robbinsville, N.J., released positive data from an international pilot study of NM100061, the firm's candidate for early ejaculation. The three-month multicenter study was double-blind, placebo-controlled and included a total of 89 patients. The primary endpoint was drug efficacy, as measured by simultaneously extending the ejaculatory latency time to more than two minutes and improving the patient's overall sexual satisfaction ratio by a minimum of 20 percent. Results show that the primary endpoint was achieved, with a satisfaction rate for patients using the product being 84.8 percent vs. 23.3 percent in the placebo group (p<0.001). Adverse events were local, mild and transient, and none of the patients reported numbness or decrease in penile sensation.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., reported results from metabolomics analyses undertaken as part of its biomarker research collaboration with the National Institutes of Health in Bethesda, Md., at the Society of Toxicology meeting. Conducted to study acetaminophen toxicity in the liver, the metabolomics data demonstrated that biochemical profiling is "a powerful tool" for generating biomarkers useful in monitoring and diagnosing liver injury, and will help to reveal the biochemical mechanisms involved in toxicity.

• PharmaMar SA, of Madrid, Spain, began a Phase I study of Aplidin, its marine antitumor agent, for pediatric solid tumors and hematological malignancies. The multicenter European trial is expected to recruit 35 to 41 patients with solid tumors and leukemias, including acute lymphoblastic leukemia, with a primary endpoint of determining a recommended dose for Phase II studies. The company said it began the trial following positive results from Phase I studies in adults with advanced solid tumors and non-Hodgkin's lymphoma, together with preclinical data. Aplidin was three to 10 times more selective toward leukemia and lymphoma cells than toward normal hemopoietic cells in preclinical studies.

• Pluristem Life Systems Inc., of Haifa, Israel, said by using its PluriX bioreactor, the firm has expanded hematopoietic stem cells to quantities large enough for transplantation in more than one adult. The company believes its technology could affect the field of cord blood transplantation and also provide an effective and immediately available source of those stem cells for bone marrow transplants in adults.

• Protein Design Labs Inc., of Fremont, Calif. reported positive findings from two clinical studies of two humanized antibodies being evaluated in ulcerative colitis and Crohn's disease. The company said a strong signal of activity was observed in both doses tested in a 32-patient Phase I trial of Nuvion (visilizumab) in patients with severe ulcerative colitis. Meanwhile, the company said HuZAF (fontolizumab) did not meet the primary endpoint at day 28 in two Phase II trials (HARMONY I and HARMONY II) in Crohn's disease following administration of a single intravenous dose. However, HuZAF demonstrated statistically greater activity compared to placebo at several subsequent time points following administration of a second intravenous dose. The trial included 133 evaluable patients. Results were presented at the International Organization of Inflammatory Bowel Disease in Monterey, Calif.

• SIGA Technologies Inc., of New York, reported preclinical results showing that mice immunized intranasally and orally with its smallpox vaccine prototype showed 100 percent immunity to vaccinia virus challenge. The product uses SIGA's live vector vaccine delivery system, which is designed to activate the immune system at the body's mucosal surfaces - the mouth, the nose, the lungs, and the gastrointestinal and the urogenital tracts - in order to prevent infection at the earliest possible stage. Separately, the company said it is exploring a divestiture of certain vaccine assets, including selected assets acquired from Plexus Vaccine Inc., of San Diego, which are not part of its core vaccine programs. SIGA bought Plexus last spring. SIGA's stock (NASDAQ:SIGA) gained 43 cents Monday, or 23.2 percent, to close at $2.28. (See BioWorld Today, April 2, 2003.)

• St. Jude Children's Research Hospital in Memphis, Tenn., said its researchers published findings in the current online issue of Nature Structural and Molecular Biology demonstrating that many proteins actually exploit disorderliness in their structure to perform a variety of different jobs. They said the discovery explains how many of the body's proteins can adapt their structures to the needs of the moment, binding to different molecules depending on the job at hand.

• Stanford University School of Medicine in Palo Alto, Calif., reported findings in the March 21, 2004, online issue of Nature showing that blood-forming stem cells are unable to replace heart muscle after a heart attack, which refutes earlier findings. In mice, blood-forming stem cells lodge in damaged hearts but retain the form of blood cells rather than transforming into muscle cells.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., completed enrollment in a Phase II study of SPI-0211 for constipation-predominant irritable bowel syndrome (IBS). The safety and efficacy study randomized 195 patients, including men and women, with documented IBS into four treatment groups (three doses of SPI-0211, a chloride channel activator, and one of placebo) in the U.S. The company said it expects to complete the study in the third quarter. SPI-0211 activates specific chloride channels on cells lining the gut, naturally increasing intestinal fluid secretion that softens the stool, promotes spontaneous bowel movements and reduces abdominal discomfort, pain and bloating.

• Targeted Molecular Diagnostics LLC, of Chicago, entered a research collaboration with Johns Hopkins University in Baltimore and the Weizmann Institute of Science in Rehovot, Israel. TMD, an oncology-focused, specialty reference laboratory that specializes in the application of molecular pathology, entered a clinical study to identify the role of a newly discovered ligand called Epigen in the clinical behavior of prostate cancer.

• Tissera Inc., of Tel Aviv, Israel, completed an equity private placement with a group of individual and institutional investors representing gross proceeds of $5.5 million. Tissera is focused on the development and commercialization of tissue-transplantation therapies using tissue precursor regeneration technologies for the treatment of disease and organ transplantation.

• Transgenomic Inc., of Omaha, Neb., signed a contract with Regado Biosciences, of Durham, N.C., to manufacture the two components of an antidote-controlled, anticoagulant therapy. Transgenomic also will provide analytical method-development stability studies and other formulation development activities in support of Regado's advance toward an investigational new drug application filing. Oligonucleotide manufacturing and related work will be completed at Transgenomic's facility in Boulder, Colo.

• ViroPharma Inc., of Exton, Pa., filed a registration statement with the SEC relating to a proposed exchange offer involving holders of its currently outstanding 6 percent convertible subordinated notes due March 2007. In the proposed exchange offer, ViroPharma would offer up to about $99.1 million aggregate principal amount of its new 6 percent convertible senior plus cash notes due 2009 for up to all of the $127.9 million aggregate principal amount of its currently outstanding 6 percent convertible subordinated notes. The company also filed a registration statement in connection with its offer to the public of an additional $25 million of the new convertible senior plus cash notes for cash. If consummated, the exchange offer will extend the maturity of the company's indebtedness by more than two additional years. Piper Jaffray & Co. is serving as the dealer manager for the exchange offer and placement agent for the cash offer.

• Weill Cornell Medical College in New York said its researchers, along with collaborators from the University of Texas Southwestern Medical Center in Dallas, Ohio State University in Columbus and the University of Saarland in Germany, published findings in the current online issue of the Proceedings of the National Academy of Sciences showing that they were able to prevent the injury-induced death of cortical neurons in mice and rats by neutralizing a protein called proNGF, which cells in the injured brain secrete. They used an antibody to proNGF to prevent its interaction with another protein called p75, a treatment that boosted nerve-cell survival to more than 90 percent in injured rats, compared to a survival rate of 61 percent to 66 percent in untreated rats.