* Alkermes Inc., of Cambridge, Mass., began a Phase II clinical trialof RMP-7, the company's receptor-mediated permeabilizer (RMP)drug delivery technology, with the chemotherapeutic agent,carboplatin, for treatment of recurrent malignant brain tumors. RMP-7 is designed to facilitate the passage of carboplatin through theblood-brain barrier. Patients will receive the drug intra-arterially via asmall catheter inserted in the major blood vessel supplying the tumor.The RMP-7 and carboplatin combination is being evaluated in otherPhase II studies where the drug is administered intravenously.
* Alliance Pharmaceutical Corp., of San Diego, and Hoechst MarionRoussel, of Frankfurt, Germany, completed an agreement, signed inFebruary 1996, giving Hoechst a worldwide license to develop andmarket Alliance's Liquivent, which is in pivotal studies for acuterespiratory failure. The agreement could be worth up to $122 millionto Alliance.
* Aphton Corp., of Woodland, Calif., said results of a Phase I/II trialof Gastrimmune, targeted for treatment of cancers of thegastrointestinal system, demonstrated the drug was safe andgenerated high levels of antibodies against Gastrin 7 hormone, whichhas been linked to colorectal, stomach and pancreatic cancers. Fiftypatients whose colon cancer had metastasized to the liver participatedin the study.
* Cel-Sci Corp., of Alexandria, Va., said it raised $1.2 million in aprivate placement of convertible debentures in the U.S. and receivedanother $250,000 through the exercise of warrants during March1996.
* Cytogen Corp., of Princeton, N.J., filed a shelf registration with theSecurities & Exchange Commission for 5 million shares. Thecompany, which said it has enough cash to operate into 1997, has notentered into any agreements related to the sale or exchange of theshares.
* CytoTherapeutics Inc., of Providence, R.I., expanded a Phase I trialof its pain control device from 15 to 25 patients in the U.S. withadvanced cancer. The device, implanted near the spinal cord,contains bovine adrenal cells, which secrete natural analgesics. Theadditional 10 patients will receive higher doses of the pain-blockingsubstances. The company said no clinically significant safety issuesor product-related adverse events have been observed in patientsparticipating in the study. CytoTherapeutics is developing the painremedy in collaboration with Astra AB, of Sodertlje, Sweden.
* Emisphere Technologies Inc., of Hawthorne, N.Y., filed aninvestigational new drug application to conduct a Phase I studyevaluating its proprietary technology for the oral delivery of heparin.If successful, the company would run a Phase II study evaluating theformulation over two weeks as a prophylaxis for deep veinthrombosis following knee and hip surgeries.
* Gensia Inc., of San Diego, received product licenses to market theGenESA system in Belgium and Portugal. Gensia now has approvalto market the system, designed for use in diagnosing coronary arterydisease, in nine European countries.
* Gilead Sciences Inc., of Foster City, Calif., began a Phase I/II trialof cidofovir topical gel for treatment of genital warts associated withhuman papillomavirus (HPV). The European studies will involve 60patients who are immunocompetent and do not have AIDS. A PhaseI/II trial in the U.S. is testing the drug for treatment of HPV-associated genital warts in HIV-infected patients. Cidofovir is anantiviral nucleotide analogue. Gilead's most advanced product,Vistide, is an injectible form of cidofovir and is under review by theFDA for AIDS-related cytomegalovirus retinitis.
* Guilford Pharmaceuticals Inc., of Baltimore, sold another 300,000shares in association with its 2 million-share public offering whenunderwriters Oppenheimer & Co. and Hambrecht & Quist LLC, bothof New York, exercised overallotment options. The offering, pricedlast week at $20 per share, generated gross proceeds of $46 million.Guilford has 9.1 million shares outstanding following the offering.
* ImmuCell Corp., of Portland, Maine, said the Center for SpecialImmunology Inc. (CSI), of Fort Lauderdale, Fla., will conductongoing clinical trials of ImmuCell's CryptoGAM for prevention ofcryptosporidiosis in AIDS patients. CryptoGAM, studied in fourPhase I/II trials, is a hyperimmune bovine immunoglobulin. Financialterms were not disclosed. ImmuCell has worldwide manufacturingand marketing rights to the drug. CSI will continue clinical trials inreturn for royalties on the product.
* NeXstar Pharmaceuticals Inc., of Boulder, Colo., said Spaincleared for marketing the company's AmBisome, a liposomal form ofthe antifungal, amphotericin B, as a second-line treatment for fungalinfections. The drug also was approved for visceral leishmaniasis inAIDS patients and others who are immune compromised. AmBisomehas now been approved in 23 countries outside the U.S.
* The Immune Response Corp., of Carlsbad, Calif., said its corporatepartner, Trinity Medical Group Co. Ltd., of Bangkok, began clinicaltrials in Thailand with Immune Response's therapeutic AIDSvaccine, Remune. The evaluation of the HIV-1 immunogen willenroll 300 AIDS patients and may be followed by other trialsinvolving up to 10,000 people infected with the deadly virus. Thestart of the Thailand clinical studies triggers a milestone paymentfrom Trinity in the form of a $5 million equity investment. Trinitywill receive 333,334 Immune Response shares for $15 per share.
* Vyrex Corp., of San Diego, completed an initial public offering(IPO) of 1 million units for $6.50 per unit generating proceeds of$6.5 million. Each unit consists of one share of Vyrex common stockand one warrant to buy another share for $8. First Equity Corp., ofMiami, managed the IPO. Vyrex's research includes developingdrugs based on antioxidants, gene discovery, cyclodextrins andapoptosis.
(c) 1997 American Health Consultants. All rights reserved.