• aaiPharma Inc., of Wilmington, N.C., said pursuant to its previously reported solicitation of consents with respect to its 11 percent senior subordinated notes due 2010 that it has received consents from holders of more than 98 percent of the notes to adopt the proposed amendments to the indenture governing the notes. All holders of record who submitted valid and unrevoked consents prior to noon EST on April 20 will receive the consent fee of $10 in cash per $1,000 principal amount of notes for which consents were delivered, subject to the terms and conditions of the solicitation.

• AEterna Laboratories Inc., of Quebec, and its wholly owned Zentaris GmbH subsidiary said a dose-ranging study is under way to evaluate EP-1572 Growth Hormone Secretagogue (GHS), an orally available peptidomimetic agent designed to stimulate growth hormone secretion from the pituitary gland. The study's initiation triggered an undisclosed milestone payment to AEterna from Ardana Bioscience Ltd., of Edinburgh, UK. Potential indications for EP-1572 include treatment of growth hormone-deficiency disorders in adults and children and frailty of the elderly, as well as metabolic complications associated with AIDS-associated cachexia, cancer and trauma.

• Avant Immunotherapeutics Inc., of Needham, Mass., received a subcontract award from DynPort Vaccine Company LLC, of Frederick, Md., to develop biodefense vaccines for the U.S. Department of Defense. The $3 million award supports the human clinical testing of Avant's oral combination vaccine against anthrax and plaque. To date, Avant has received subcontracts totaling more than $7 million in funding for the combination vaccine program.

• Bioenvision Inc., of New York, reported the presentation of interim Phase II data for clofarabine as first-line treatment in older adults with acute myeloid leukemia considered unsuitable for intensive chemotherapy. Clofarabine achieved a complete response rate of 64 percent. Those data were presented Wednesday at the British Society of Hematology meeting in Cardiff, UK. The investigator-sponsored study has enrolled 18 patients to date, of which an interim analysis has been performed on 14. Nine out of those 14 patients have shown a complete response using clofarabine as a single agent, the company said.

• CuraGen Corp., of New Haven, Conn., initiated a Phase I study of CG53135 for oral mucositis (OM) in cancer patients undergoing bone marrow transplantation. The study will evaluate CG53135 in about 15 patients. CG53135 also is being investigated for the prevention of OM in patients with solid tumors, such as colorectal cancer, as well as patients with hematologic tumors, such as the ones that require bone marrow transplantation.

• CV Therapeutics Inc., of Palo Alto, Calif., said Ranexa produced statistically significant increases in exercise duration and time to onset of angina pain in a Phase III clinical study. Results of the drug, which is being developed to treat chronic angina, will be published this week in the Journal of the American College of Cardiology. The drug continues to demonstrate anti-anginal activity without compromises in heart rate or blood pressure, the company said. About 191 angina patients were enrolled in the study. They were randomized to receive placebo or Ranexa twice a day at different doses. Dose-related adverse events included dizziness, nausea, asthenia and constipation.

• Diversa Corp., of San Diego, said its scientists are the first to link the precise function of proteins to genetic sequence information derived from complex microbial communities, such as those living in tropical rainforests and deep ocean vents. Diversa said it believes advances such as that in metabiology will help address issues such as energy production, understanding infectious disease mechanisms and improving nutrition. Also, Diversa said it received undisclosed additional grant funding from the Department of Energy to apply its high-throughput culturing technology for growing previously uncultured microbes, combined with other metabiology technologies, to problems posed by large-scale sequencing of microbial communities.

• Enzo Biochem Inc., of Farmingdale, N.Y., said its subsidiary Enzo Therapeutics Inc. entered two agreements with the University of Connecticut Health Center to license and develop therapeutics to stimulate and enhance bone formation. The technology relates to the modulation of signaling pathways in cell development and differentiation by signaling proteins and small molecular compounds or drugs. Under the agreement, Enzo holds an exclusive license for the technology and is a co-inventor along with university scientists.

• ESP Pharma Inc., of Edison, N.J., said the FDA granted orphan drug designation to the company's lead drug, hydralazine hydrochloride, a peripheral vasodilator. The designation is for the treatment of severe intrapartum hypertension associated with severe pre-eclampsia and eclampsia of pregnancy. ESP Pharma, in collaboration with Northfield, Ill.-based Barbeau Pharma Inc. is working to develop an improved intravenous formulation of hydralazine, which is an approved anti-hypertensive agent.

• Hemosol Inc., of Toronto, said shareholders approved a resolution authorizing the previously disclosed arrangement involving Hemosol, its shareholders and MDS Inc., of Toronto. Under the arrangement, Hemosol will, in effect, exchange a portion of its tax losses and other tax assets for a cash infusion of C$16 million (US$11.8 million). The arrangement is expected to close on or about April 30. Hemosol is developing Hemolink, an oxygen therapeutic, designed to improve oxygen delivery via the circulatory system.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, completed its acquisition of Adprotech Ltd., of Cambridge, UK. Inflazyme issued about 12.7 million shares in exchange for all of the issued and outstanding shares of Adprotech. Adprotech shareholders now will hold about 12 percent of the outstanding Inflazyme shares. Adprotech shareholders agreed to lock up their shares, which will be released on a percentage basis from a date four months after completion of the acquisition. Shareholders in privately held Adprotech agreed in early April to be taken over by Inflazyme for about C$20 million (US$14.9 million) in shares. (See BioWorld Today, April 13, 2004.)

• Inspire Pharmaceuticals Inc., of Durham, N.C., initiated a Phase II trial for INS37217 Ophthalmic (denufosol tetrasodium) for the treatment of rhegmatogenous retinal detachment (RRD). The double-masked, randomized, placebo-controlled, parallel-dose study is designed to compare the safety and efficacy of INS37217 Ophthalmic to placebo as a first-line therapy in patients with RRD. The study will enroll about 160 patients in 25 centers across the U.S.

• Integrated BioPharma Inc., of Hillside, N.J., raised $8.5 million from a private placement of 850 shares of newly issued Series B redeemable convertible preferred stock at $10,000 apiece with a group of institutional investors led by Alexandra Investment Management LLC. The stock is convertible at $10 per share into common shares at the option of each investor. The company also issued five-year warrants to purchase 425,000 additional shares at an exercise price of $14 each, as well as rights entitling the investors over the next 18 months to purchase 425 additional Series B preferred shares, convertible into 425,000 common shares, and warrants to purchase an additional 212,500 common shares. Integrated BioPharma produces paclitaxel and related drugs through one subsidiary and is developing preventive cancer compounds in transgenic plants through another.

• Introgen Therapeutics Inc., of Austin, Texas, said the Southwest Oncology Group in San Antonio began a clinical trial of Advexin for Stage III or IV squamous-cell carcinoma of the oral cavity, or oropharynx, which is able to be removed surgically. The study is designed to assess the feasibility, efficacy and safety of administering the gene therapy at the time of surgery for suppression of remaining tumor cells, followed by a combination of chemotherapy and radiation therapy.

• Isotechnika Inc., of Edmonton, Alberta, said it received approval from Health Canada for the multiple dose-finding study of trans-ISA247. The multiple-ascending-dose study will involve about 36 subjects over a nine-week period. Data from the study will be used to determine the dose in future clinical trials for psoriasis and renal transplantation. Isotechnika hopes to enter a Canadian Phase III psoriasis trial by the end of the year. (See BioWorld Today, April 21, 2004.)

• Marshall Edwards Inc., of Washington, began a multicenter trial to study the ability of phenoxodiol to restore the sensitivity of ovarian cancer to the standard chemotherapies, paclitaxel and cisplatin. Yale-New Haven Hospital in Connecticut will enroll about 40 patients in the study. It will be expanded to another site later this year. In laboratory studies, phenoxodiol has been shown to restore sensitivity to standard chemotherapies in ovarian cancer cells.

• MIV Therapeutics Inc., of Vancouver, British Columbia, said it raised additional funds to complete the next stage of its research and development program for its biocompatible coating technology being developed for cardiovascular stents and other medical devices. MIV entered agreements with accredited investors for the sale of common stock and warrants for gross proceeds of $700,000. The company has raised more than $3 million in fiscal 2004. With the most recent financing, MIV sold about 1.6 million shares, and issued to investors Series A and Series B warrants to purchase 1.6 million shares at 66 cents per share and 400,000 shares at 75 cents per share. Ducan Capital LLC served as placement agent.

• Nanogen Inc., of San Diego, completed its all-stock acquisition of SynX Pharma Inc., of Toronto. SynX now is a wholly owned subsidiary of Nanogen, which operates in the in vitro diagnostics market.

• Neose Technologies Inc., of Horsham, Pa., signed an agreement with BioGeneriX AG, of Mannheim, Germany, to use Neose's GlycoPEGylation technology to develop a long-acting, next-generation version of granulocyte-colony stimulating factor (G-CSF). They will share preclinical expenses, and BioGeneriX will fund the clinical development program. Neose, which is receiving an up-front fee, will have commercial rights in the U.S., Canada, Mexico and Japan. BioGeneriX will have commercial rights in Europe and the rest of the world. Each company will receive royalties on sales in the other company's territory. Separately, Neose delayed plans to file an investigational new drug application for GlycoPEG-EPO to the second quarter of next year. The company stressed that the delay is not connected to any concerns over the product, but is required to increase post-purification output.

• NuGEN Technologies Inc., of San Carlos, Calif., said the University of Rochester in New York will begin using its Ovation system as the standard RNA amplification and labeling systems in its Functional Genomics Center. The facility will be using the Ovation System for most new studies requiring RNA amplification and labeling.

• One Cell Systems Inc., of Cambridge, Mass., received about $950,000 through a Phase II Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md., to develop a fluorescence in situ hybridization assay for detecting levels of telomerase mRNA in cancer cells. The company said telomerase activation is associated with the onset and proliferation of most cancers, but is not possible to discriminate mRNA telomerase expression in single cells using current methods.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said its board approved an investment of up to an additional $40 million in its UK-based diabetes subsidiary, Prosidion Ltd. The first $10 million installment will be invested immediately at a cost of $10 per share, and will give OSI an 81 percent ownership position in the majority-owned subsidiary. The investment was based on a $24 million valuation of Prosidion. In January 2003, OSI decided to focus its core research and development activities on oncology, forming Prosidion in order to provide a vehicle to pursue research in diabetes and obesity.

• PharmaMar SA, of Madrid, Spain, said data on Aplidin showed the marine antitumor agent is an inducer of apoptosis in leukemic cells, and is active against human multiple myeloma cell lines and primary multiple myeloma tumor cells isolated from patients. The company plans to begin Phase II trials of Aplidin in multiple myeloma this year in Europe and the U.S. Aplidin is a cyclodepsidpeptide derived from the marine tunicate Aplidium albicans.

• Tissera Inc., of Tel Aviv, Israel, identified the optimal gestational window to harvest and dissect embryonic tissue in pigs to differentiate between teratoma-producing tissue as opposed to precursor tissue, which leads to heart, liver and pancreas development without teratoma. The specific embryonic anatomical sites that serve as tissue precursors for different organs exhibit different windows.

• Tm Biosciences Corp., of Toronto, announced the launch of Tag-It Cystic Fibrosis (CF) ASR products for the detection of mutations in the gene associated with CF. The products are manufactured to Analyte Specific Reagent (ASR) regulatory specifications. The Tag-It ASRs will be used to identify 39 mutations and four variants of the cystic fibrosis transmembrane conductance regulator gene. Tm Bioscience is a DNA-based diagnostics company that develops genetic tests.