¿ Adolor Corp., of Exton, Pa., was awarded three Small Business Innovation Research grants from the National Institutes of Health to fund research into novel compounds for pain relief. A Phase II award will support research to develop small-molecule antagonists of the ORL-1 receptor and determine their therapeutic utility in the treatment of inflammatory and neuropathic pain. A Phase I award for $113,000 will aid research focusing on an artificial protein designed to identify small-molecule drug candidates that activate kappa opioid receptors. Another Phase I award, for $157,110, will fund research focusing on the discovery and development of small-molecule activators of cannabinoid receptors expressed on peripheral nerves.
¿ Alliance Pharmaceutical Corp., of San Diego, said data from a preclinical study reported in the recent issue of Blood, the journal of the American Society of Hematology, showed that Oxygent (perflubron emulsion) reduced the vaso-occlusion associated with sickle cell disease. Oxygent, an intravascular oxygen carrier, dislodged sickled red blood cells that were trapped in blood vessels. The product also helped reverse the partial obstruction of the vessels, causing an improvement of hemodynamic parameters. A comprehensive report and a clinical trial outline for a new Phase III study are being finalized for submission to the FDA within several weeks.
¿ Bioject Medical Technologies Inc., of Portland, Ore., said it signed a second agreement with Amgen Inc., of Thousand Oaks, Calif., following the initial supply and license agreement signed in March 2000. The new contract broadens Amgen¿s potential use of Bioject¿s needle-free injection system and includes product licensing and commercial supply terms. Bioject will provide Amgen with an exclusive license for use of a modified version of the Bioject B2000 needle-free injection system for certain undisclosed therapeutics. Bioject receives an up-front payment of $1 million, as well as development milestones and other payments.
¿ BioMarin Pharmaceutical Inc., of Novato, Calif., completed its public offering of common stock, selling about 8 million shares, including about 1.05 million to cover overallotments, at a price of $12 per share. The offering raised $96.6 million, with proceeds to BioMarin, before expenses, of approximately $90.8 million. (See BioWorld Today, Dec. 10, 2001.)
¿ Cell Pathways Inc., of Horsham, Pa., reported the presence, in breast cancer cells, of the cyclic GMP phosphodiesterases (cGMP PDEs) targeted by the company¿s selective apoptotic antineoplastic drugs (SAANDs). SAANDs, including Aptosyn (exisulind) and CP461, inhibit certain cyclic GMP PDEs found to be overexpressed in a variety of tumor types. Investigators also demonstrated that inhibition of these cGMP PDEs decreased another important protein, beta-catenin. The accumulation of beta-catenin within the cell has been implicated in the growth of several types of cancers including, most recently, breast cancer. The findings were presented during the annual San Antonio Breast Cancer Symposium.
¿ Exelixis Inc., of South San Francisco, and Bristol-Myers Squibb Co., of New York, identified and selected the first small-molecule cancer targets in their collaboration using Exelixis¿ screening platform to identify targets to fight cancer. The targets will now move into drug discovery programs at both companies. The collaboration, valued at up to $200 million, was established in July 2000. (See BioWorld Today, July 19, 2001.)
¿ Gene Logic Inc., of Gaithersburg, Md., formed a genomics database agreement with Aventis Pharmaceuticals Inc., the U.S. pharmaceuticals division of Aventis Pharma AG, of Frankfurt, Germany. Aventis will establish a CustomSuite subscription, gaining access to a customized selection of biosamples across a specific group of organ types culled directly from the BioExpress Module of Gene Logic¿s gene expression database, the GeneExpress Suite. The agreement also calls for data generated from samples provided by Aventis. These data will be integrated with the Gene Logic data in the CustomSuite data product. The resulting combined database tool will be housed within Gene Logic¿s bioinformatics interface, the GeneExpress Software System. Financial details were not disclosed.
¿ Genzyme General, of Cambridge, Mass., said it was added to the S&P 500 Index, effective at the close of trading Thursday.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, raised $11.5 million through the sale of about 1.3 million shares at $9 per share. It also issued warrants to purchase up to 128,000 shares of common stock having an exercise price of $12. The warrants are exercisable in cash for a period of two years. The company said it intends to use the funds to conduct clinical trials with its immune-regulating hormones in a number of indications. Hollis-Eden is engaged in the discovery, development and commercialization of products for the treatment of infectious diseases and immune system disorders, including HIV/AIDS, hepatitis C and malaria. Its lead compound in this series, HE2000, is in Phase I/II studies in the United States and South Africa.
¿ Inex Pharmaceuticals Corp., of Vancouver, British Columbia, closed its offering of 6,145,000 common shares at a price of C$7 per share, in connection with the previously announced agreement with an underwriting syndicate led by BMO Nesbitt Burns Inc., and including Raymond James Ltd., RBC Dominion Securities Inc., Yorkton Securities Inc. and Dlouhy Merchant Group Inc. The gross proceeds of the offering totaled C$43 million (US$27.4 million). The proceeds will be used to continue to invest and broaden the clinical and commercial opportunity for INEX¿s lead product, Onco TCS, as well as to accelerate and expand the pipeline. (See BioWorld Today, Nov. 27, 2001.)
¿ Introgen Therapeutics Inc., of Austin, Texas, said INGN 241, its mda-7 gene drug, suppresses the growth of lung cancer tumors, as shown in preclinical studies. The data were presented at the 10th International Conference on Gene Therapy of Cancer in San Diego. Previous studies have shown that the product suppresses lung tumor cell proliferation in vitro. However, the new studies demonstrate INGN 241¿s tumor suppressing and anti-angiogenic activity in vivo.
¿ MediGene AG, of Munich, Germany, began an open-label Phase Ib/II trial for its anticancer therapeutic G207 in patients with recurrent malignant brain tumors. G207 is a modified herpes simplex virus that has been genetically engineered to selectively multiply in tumor cells and cause cancer cell death without harm to surrounding healthy tissue. The Phase Ib trial is designed to evaluate safety and tolerability of different doses of G207, and to select the dose for the Phase II trial that will evaluate safety and survival at six months. Overall, the trial may enroll up to 65 patients with recurrent malignant glioma at six U.S. centers.
¿ MGI Pharma Inc., of Minneapolis, expanded its ongoing Phase II trial of irofulven, its novel anticancer compound, for patients with unresectable hepatocellular carcinoma (inoperable liver cancer). The trial expansion criterion was met with a confirmed objective partial response (greater than 50 percent tumor shrinkage) observed in a liver cancer patient, resulting in this expansion. Patient enrollment is expected to be completed in 2002, and an additional Phase II trial of irofulven for liver cancer patients is anticipated to begin in early 2002 using the every-other-week dosing schedule of the drug.
¿ Nastech Pharmaceutical Company Inc., of Hauppauge, N.Y., reported results of a Phase II trial in 184 men with erectile dysfunction that concluded its nasally administered apomorphine formulation demonstrated efficacy and tolerance. The drug also showed an onset of action, about 15 minutes after dosing, that uniquely matches normal human sexual response physiology. The study supports the final stages of the clinical development of the product and Nastech expects the pivotal Phase III trials to begin early next year.
¿ National Institutes of Health provided a boost in the form of $1.1 million grants for research on facioscapulohumeral muscular dystrophy (FSHD), a genetic disease of skeletal muscle. The six new grants, designed to support both basic and clinical research studies, were awarded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Neurological Disorders and Stroke. FSHD is the third most common genetic disease of skeletal muscle, affecting approximately one in 20,000 people. Symptoms may begin during infancy, late childhood or early adulthood.
¿ Nymox Pharmaceutical Corp., of Maywood, N.J., said its management and board members intend to continue to purchase up to 1 million shares of its common stock in the open market. The company expects the purchases will take place over a period of 18 months. Nymox is working to develop treatments for Alzheimer¿s disease and other indications using its drug-screening technology.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, released interim Phase I results for Reolysin, a potential cancer therapeutic for RAS-activated cancers. None of the patients to date has experienced any serious adverse events related to the virus nor were there any dose-limiting toxicities detected. As secondary endpoints, Oncolytics measured tumor response at both the treated lesion and remote metastatic sites. Evidence of viral activity in tumors was observed, ranging from changes in structure to partial and complete regression in the injected tumors. In 12 of 18 patients, 50 percent of injected tumors showed evidence of viral activity. Preliminary evidence of remote responses was also noted.
¿ Serono SA, of Geneva, received confirmation from the FDA that the agency will convene its Peripheral and Nervous System Drugs Advisory Committee regarding Serono¿s pending biologics license application for its multiple sclerosis drug, Rebif (interferon beta-1a). The committee is scheduled to meet on Feb. 15. Serono submitted additional data to the FDA during the third quarter of 2001 as an amendment to its original BLA, filed in March 1998.
¿ SignalGene Inc., of Montreal, said small molecules developed under its angiogenesis inhibitor program for cancer therapies showed positive results in preclinical tests to assess their biological action in cell-based assays. The small-molecule inhibitors were produced with SignalGene¿s chemotype shifting drug design technology.
¿ Synaptica Ltd., of Oxford, UK, opened its newly refurbished, 4,000-square foot lab complex. The company said the space is sufficient for 30 research scientists and will be useful into 2003. Synaptica, a private neuroscience company developing therapies for Alzheimer¿s, Parkinson¿s and motor neuron disease, retains the option to expand on the same site.
¿ Targeted Genetics Corp., of Seattle, filed a shelf registration statement with the SEC for the sale of up to about 8.8 million shares of common stock, giving the company the flexibility to sell its stock at its discretion. The shelf registration could raise a total of about $23.5 million, based on Wednesday¿s closing price of $2.66.
¿ Theratechnologies Inc., of Montreal, completed its recently announced offering of 2,546,000 common shares to a group of underwriters led by Yorkton Securities Inc. at a price of $10.25 per share, raising $26 million. The underwriters retain an option, exercisable within 30 days of the closing date, to acquire an additional 382,000 common shares for purposes of covering overallotments and for market stabilization. (See BioWorld Today, Nov. 28, 2001.)