• Adherex Technologies Inc., of Research Triangle Park, N.C., said data from its proof-of-mechanism trial of eniluracil showed that three patients who received a single, oral dose of the drug 12 to 14 hours prior to surgery for colorectal cancer resulted in inhibition of dihydropyrimidine dehydrogenase (DPD) activity. The company also reported results from 16 patients enrolled to date in its Phase I trial of eniluracil plus 5-fluorouracil in solid tumors. In the 13 patients for whom DPD results were available, DPD was inhibited at the time of 5-FU dosing, which was given 12 to 20 hours after eniluracil.

• Antisoma plc, of London, said final Phase II data reported at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showed that non-small-cell lung cancer patients who received AS1404 in addition to standard chemotherapy had a median survival 5.2 months longer than that of patients who received standard chemotherapy alone (14 months vs. 8.8 months). Addition of AS1404 reduced the risk of death by 27 percent. In addition, patients who received AS1404 and chemotherapy had 23 percent increases in both median (5.4 months vs. 4.4 months) and mean (6.3 months vs. 5.1 months) time to tumor progression compared with patients on chemotherapy alone.

• Argenta Discovery Ltd., of Harlow, UK, initiated a Phase I trial with ADC4022 for chronic obstructive pulmonary disease and severe asthma. The trial is to enroll 36 healthy volunteers for ADC4022 dosage by inhalation, to assess the tolerability and pharmacokinetics of single and multiple doses of the drug given alone and with inhaled corticosteroids.

• Bioniche Life Sciences Inc., of Belleville, Ontario, began a Phase III trial of Urocidin (MCC, or mycobacterial cell wall-DNA complex) in refractory bladder cancer. The open-label study will include 105 patients to show the efficacy of Urocidin in superficial bladder cancer refractory to Bacillus Calmette-Guérin (BCG), a live, attenuated strain of Mycobacterium bovis that is standard therapy in this indication. The trial will be conducted in North America and last between three and four years. This study is the first of two in the company's Phase III bladder cancer program, with a second trial to test Urocidin as first-line therapy to begin next year. It will compare Urocidin to BCG in treatment-naive non-muscle invasive bladder cancer patients.

• Cellgate Inc., of Redwood City, Calif., began a Phase I study of CGC-11047 for age-related macular degeneration (AMD). The open-label trial is designed to determine the product's safety and tolerability in that population, and a total of 15 patients will be treated in cohorts of escalating doses. They will receive the drug subconjunctivally, avoiding the need to inject into the eye. CGC-11047 is a polyamine analogue that targets the hyper-proliferating blood vessel growth, known as choroidal neovascularization, associated with AMD.

• Dendreon Corp., of Seattle, said preliminary results from an ongoing Phase II trial of Provenge (sipuleucel-T) demonstrated a prolongation in prostate-specific antigen doubling time (PSADT) in patients who received the product compared to placebo. Specifically, patients randomized to receive Provenge had a 35 percent increase in their PSADT compared to those on placebo (p=0.046). In addition, there was a delay of nearly 27 percent in the time to distant metastasis for Provenge patients compared to placebo. The PROTECT (Provenge Treatment and Early Cancer Treatment) study was designed to explore Provenge's biologic activity in androgen-dependent patients with recurrent prostate cancer prior to the development of metastatic disease. Dendreon plans to submit the data for presentation at a future medical meeting.

• DNA Therapeutics SA, of Evry, France, presented data at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showing its short inhibiting DNA molecule Dbait, in association with radiotherapy, induced necrosis of tumors in mouse models superior to radiotherapy alone. The company anticipates starting clinical trials late in 2007 or early in 2008.

• Emisphere Technologies Inc., of Tarrytown, N.Y., said additional Phase II results showed the high dose of its oral insulin product, 10 mg QID, had the most profound effect on HbA1c reduction. Specifically, in patients with HbA1c levels of 8 percent to 8.9 percent, a statistically significant decrease vs. placebo (p=0.03). In patients with HbA1c levels at baseline between 7 percent and 8.9 percent, a decrease of 0.1 percent was seen in patients on oral insulin vs. a 0.05 percent increase on placebo. In patients with HbA1c levels of 7.5 percent to 8.9 percent, a decrease of 0.22 percent was seen in patients on oral insulin vs. a 0.075 percent increase on placebo. The oral insulin product employs the company's eligen oral delivery technology.

• Exelixis Inc., of South San Francisco, said updated data from a Phase I study of XL999, an investigational cancer therapy, showed preliminary evidence of antitumor activity when administered weekly or every two weeks by intravenous infusion. Of the 45 patients enrolled as of Oct. 1, three have had partial responses and 10 others have had stable disease for three to 25.5-plus months. Cardiac failure and elevated hepatic transaminases were identified as dose-limiting toxicities. Those results were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic. At that same meeting, the company also presented preliminary results from a Phase I trial showed that XL820, an oral, small-molecule compound designed to inhibit tumor growth and angiogenesis, generally was well tolerated when dosed for five consecutive days every two weeks. A maximum tolerated dose has not yet been identified.

• Genta Inc., of Berkeley Heights, N.J., said new analyses from its Phase III trial of Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukemia showed that patients who were prospectively stratified as being non-refractory were four times more likely to achieve complete remission with Genasense as those treated with chemotherapy alone. Those non-refractory Genasense-treated patients also achieved a statistically significant increase in overall survival. Data were presented at the 24th annual Symposium of the Chemotherapy Foundation in New York. Genta submitted a new drug application late last year for Genasense in CLL in combination with fludarabine and cyclophosphamide, and the FDA recently extended the review period for 90 days. (See BioWorld Today, Dec. 30, 2005.)

• Human Genome Sciences Inc., of Rockville, Md., reported interim Phase Ib results at the EORTC-NCI-AACR meeting in Prague, Czech Republic, showing that HGS-ETR1 (mapatumumab) in combination with gemcitabine and cisplatin was well tolerated and could be administered safely and repetitively, and was well tolerated, at doses up to 20 mg/kg in patients with advanced solid tumors. In addition, objective responses were observed in nine patients to date, and stable disease was observed in 14. Also, the pharmacokinetics of gemcitabine and cisplatin were not influenced by HGS-ETR1 co-administration, or vice versa. The maximum tolerated dose has not been reached, and enrollment continues at 20 mg/kg.

• ImmunoGen Inc., of Cambridge, Mass., said initial data from an ongoing Phase I study of its huC242-DM4 compound in colorectal, pancreatic, gastric and other CanAg-expressing cancers showed that 28 patients have received at least one dose of the compound, with no reports of clinically significant myelosuppression. The trial is designed to establish the dose-limiting toxicities and to find the maximum tolerated dose of huC242-DM4 when administered once per three weeks.

• InSite Vision Inc., of Alameda, Calif., said it started a Phase I safety trial for AzaSite Plus (ISV-502), a combination of azithromycin and dexamethasone in DuraSite - the company's drug delivery system for topical ophthalmic indications. The product would be indicated for ocular treatment in which inflammation and bacterial infection are present, as in conditions such as blepharitis. Phase I will evaluate safety and tolerability of the AzaSite Plus formulation in normal volunteers.

• Manhattan Pharmaceuticals Inc., of New York, said it is adding sites for its Phase IIa trial for oral oleoyl-estrone (OE) for adult obesity. In addition to Switzerland, patients will be recruited in Salt Lake City and Baton Rouge, La., and dosing should begin at the new sites by mid-November. The trial is a randomized, double-blind, placebo-controlled, parallel-group study with about 100 obese adults with a body mass index of 27 to 38.9. It will evaluate safety, efficiency and pharmacokinetics for two 14-day dosing cycles of 5 mg, 10 mg or 20 mg of oral OE compared to placebo.

• OxiGene Inc., of Waltham, Mass., dosed the first patient in a Phase Ib trial of its lead vascular disrupting agent, CA4P, in combination with Avastin (bevacizumab, Genentech Inc.) in advanced solid tumors. In a recent scientific publication, the combination of a VDA with an anti-angiogenic agent was shown to be successful in suppressing tumor growth. The trial is designed as a dose-escalation study to evaluate the safety and efficacy of that combination.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said interim data from an ongoing Phase I study of PPI-2458 suggested that the oral small molecule is well tolerated at doses up to 8 mg, and the maximum tolerated dose has not yet been determined. PPI-2458 is designed to target methionine aminopeptidase-2, which is overexpressed in certain cancers, including non-Hodgkin's lymphoma. Results, which included data for 32 subjects treated across four dose cohorts, were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

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