Advaxis Inc., of Princeton, N.J., said its common stock has been approved for listing on the Over-the-Counter Bulletin Board, and trading began Thursday, under the symbol "ADXS." Advaxis is developing cancer vaccines designed to enhance the immune system's cancer-fighting abilities.
Altea Therapeutics Corp., of Atlanta, raised more than $30 million in its Series C round. Altea said it will use the proceeds to continue clinical development of its lead products for pain management and diabetes control. The company develops products based on a class of advanced transdermal patches designed to deliver sustained therapeutic levels of proteins and water-soluble drugs. The financing was led by Aperture Venture Partners, and also included Series B investors Domain Associates, Venrock Associates and vSpring Capital. Other investors were KBC, Quilvest Capital, CX Ventures, and Rockport Ventures. In connection with the investment, Paul Tierney, of Aperture and Ruth Devenyns, of KBC, joined Altea's board.
Biolex Therapeutics Inc., of Pittsboro, N.C., acquired LemnaGene SA, of Lyon, France, a company that provides biomanufacturing services to various markets, and one that has several research agreements in the pharmaceutical and human/animal vaccine areas. The acquisition gives Biolex protein capabilities.
Cara Therapeutics Inc., of Tarrytown, N.Y., said Phase I trial results showed its peripherally acting kappa opioid agonist, CR665, was safe and well tolerated. It is being developed as a treatment for post-operative pain. The drug also displayed plasma levels associated with clinical analgesic activity.
Competitive Technologies Inc., of Fairfield, Conn., granted a homocysteine assay license to Beckman Coulter Inc., of Fullerton, Calif. Elevated levels of homocysteine resulting from vitamin B12 and folate deficiency might be a risk factor in heart attacks, strokes, blood clots, various pregnancy complications, dementia from Alzheimer's disease, rheumatoid arthritis, osteoporosis and presbyopia. Beckman Coulter will pay an initial license fee and royalties on sales of homocysteine assay products.
Cortex Pharmaceuticals Inc., of Irvine, Calif., began enrollment in the second and third Ampakine CX717 Phase IIa studies - one in attention deficit hyperactivity disorder, and the other in mild to moderate Alzheimer's disease. The fourth Phase IIa study in simulated night shift work is scheduled to start enrollment at the end of August. In May, the company reported positive results in the first Phase IIa study, which suggested that CX717 may provide a new approach to enhancing memory cognition and wakefulness by cortical arousal without systemic stimulating effects.
CV Therapeutics Inc., of Palo Alto, Calif., submitted to the FDA an amendment to the new drug application for Ranexa (ranolazine) to treat chronic angina in a restricted patient population. The amendment is intended to provide a complete response to the approvable letter received in October 2003. It is based on a recently completed trial that met its primary endpoint and was conducted under the FDA's special protocol assessment. Ranexa, if approved, could be launched in the first half of 2006. (See BioWorld Today, April 19, 2005.)
Cytokinetics Inc., of South San Francisco, started two additional trials involving ispinesib, its kinesin spindle protein inhibitor, bringing the total number of Phase II trials being conducted by London-based GlaxoSmithKline plc or the National Cancer Institute to eight in multiple settings of advanced cancer. Cytokinetics also is set to start a trial for CK-1827452, its lead cardiac myosin activator, this year.
DiscoveRx Corp., of Fremont, Calif., launched the latest additions to its kinase product portfolio, ADP Quest and TK Substrate Quest. Both products introduce a novel fluorescence-based approach for detection of ADP in solution as a result of kinase or ATPase activity.
Encysive Pharmaceuticals, of Houston, completed the submission of a marketing authorization application with the European Agency for the Evaluation of Medicinal Products for Thelin 100 mg as a once-daily oral treatment for patients with pulmonary arterial hypertension. Earlier this year, the company filed its new drug application with the FDA. (See BioWorld Today, May 26, 2005.)
Enzon Pharmaceuticals Inc., of Bridgewater, N.J., established new share ownership guidelines, requiring members of senior management to acquire and maintain share holdings in the company's common stock in amounts expressed as a multiple of each executive's base salary. The guidelines will align the compensation of senior executives with the company's performance and the interests of its shareholders.
EvoGenix Ltd., of Sydney, Australia, closed its initial public offering, raising A$9 million (US$6.8 million) through the issue of 36 million shares at A$0.25 cents each. The company is expected to list on the Australian Stock Exchange in early August with a post-listing market capitalization at the issue price of A$32.2 million. The company focuses on identifying and developing antibody-based drugs.
Genesis Bioventures Inc., of New York, received notice from the American Stock Exchange that the company does not meet certain continued listing standards, and it must submit a plan of action by Aug. 18. The company has had trouble sustaining those standards due to the abandoned proposed merger with Corgenix Medical Corp., of Denver, in January. Management is in the process of securing a bridge financing that will allow the company to continue operations until a larger private placement can be completed.
Genzyme Corp., of Cambridge, Mass., announced positive results from the dialysis clinical outcomes revisited (DCOR) trial, which involved more than 2,100 chronic kidney disease patients over three years. It compared the difference in mortality and morbidity outcomes, and demonstrated that patients treated with Renagel (sevelamer hydrochloride) for two years or more, and those over 65, experienced a stronger clinical benefit than those treated with calcium-based phosphate binders.
GTC Biotherapeutics Inc., of Framingham, Mass., and Scancell Ltd., of Nottingham, UK, signed an agreement to evaluate the expression of Scancell's SC101 cancer monoclonal antibody using GTC's transgenic production platform. The agreement contemplates that both companies will work toward establishing a definitive agreement for the clinical development of SC101.
Harvard Biosciences Inc., of Holliston, Mass., plans to divest its capital equipment business and is working to engage an investment bank to assist in the process. The business fell short of expectations in the second quarter.
Introgen Therapeutics Inc., of Austin, Texas, made a $3 million equity investment in SR Pharma plc, of London, resulting in an 8.3 percent stake. The investment will be used to develop SR Pharma's siRNA technology in the oncology area, including atuPLEX, its delivery system accessed recently through its acquisition of Atugen AG, of Berlin. Separately, SR Pharma said it raised £8.3 million (US$14.5 million) via a placement with institutional investors.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis division has been granted a $1.1 million contract from the U.S. government, under subcontract from San Diego-based Science Applications International Corp. The Ibis division has developed the TIGER (triangulation identification for genetic evaluation of risks) biosensor system, which identifies infectious organisms. The company plans to commercialize the system to government customers for use in biowarfare defense, epidemiological surveillance and forensics.
Paratek Pharmaceuticals Inc., of Boston, said it is conducting a Phase I trial of its lead compound from a new class of antibiotics called aminomethylcyclines, derived from the tetracycline family. PTK 0796 has been shown to be effective in animal models at treating clinically prevalent infections caused by Gram-positive, Gram-negative, atypical and anaerobic bacteria, including those with multidrug resistance.
ParinGenix, of Tucson, Ariz., named Eric Leire CEO. The company is developing multiple products based on a modified form of heparin. It plans to start Phase II trials of PGX-100 in acute exacerbations of chronic obstructive pulmonary disease and in cardiac ischemia reperfusion injury following myocardial infarction.
Prolexys Pharmaceuticals Inc., of Salt Lake City, is participating in an international consortium of investigators to work on finding drugs to treat latent tuberculosis infection. The consortium leader is Douglas Young, of Imperial College in London, and it is supported by a $20 million grant from the Grand Challenges in Global Health initiative, which was launched in 2003. Prolexys will be responsible for the proteomics component of the project.
Pro-Pharmaceuticals Inc., of Newton, Mass., said the SEC has terminated its investigation, begun in October 2003, without recommendation of any enforcement action. The company focuses on the development and commercialization of a new generation of cancer treatments using carbohydrate compounds to glyco-upgrade the safety and efficacy of FDA-approved chemotherapy drugs.
Savient Pharmaceuticals Inc., of East Brunswick, N.J., completed its end-of-Phase II meeting with the FDA for Puricase to treat refractory gout. The company will continue to meet with the FDA to finalize the details of the Phase III program, and it has elected to submit a special protocol assessment to the FDA. The trial could begin in the first quarter of 2006.
Schering AG, of Berlin, and Novartis Pharma AG, of Basel, Switzerland, said its Confirm II trial of PTK/ZK as a first-line treatment of metastatic colorectal cancer probably will not demonstrate an improvement in overall survival, as assessed by a data safety monitoring board. Overall survival results are expected in mid-2006. The companies are reviewing the regulatory filing strategy and timelines for the drug, a competitor of South San Francisco-based Genentech Inc.'s Avastin. Schering and Novartis said in March that the first pivotal trial, Confirm I, did not meet its endpoint. (See BioWorld Today, March 22, 2005.)
Sigma-Genosys, a division of St. Louis-based Sigma-Aldrich, has incorporated into its quality control lab an LC-MS system from Novatia, of Princeton, N.J. The system improves the molecular weight determination of larger synthetic oligonucleotides, as well as synthetic peptides.
Third Wave Technologies Inc., of Madison, Wis., appointed David Thompson chairman. He was the senior vice president and president of the diagnostic division of Abbott Laboratories, of Abbott Park, Ill. Lance Forse, who co-founded Third Wave in 1993, has resigned as executive chairman and is leaving the board, but will remain a technology adviser. The company also appointed James Connelly to the board.
ZymoGenetics Inc., of Seattle, intends to offer 6.5 million primary shares of common stock in a public offering. It has granted the underwriters an option to buy 975,000 shares to cover overallotments. Merrill Lynch & Co. will act as the lead manager for the offering, while Pacific Growth Equities LLC; Bear, Stearns & Co. Inc.; and Piper Jaffray & Co. will act as co-managers.