• Arena Pharmaceuticals Inc., of San Diego, presented positive Phase IIa trial results of APD125, an oral selective inverse agonist of the 5-HT2A serotonin receptor, for the treatment of insomnia. The results showed that when compared to placebo, patients treated with APD125 experienced statistically significant improvements in polysomnographic measurements of sleep maintenance, or the ability to maintain sleep during the night after falling asleep. These improvements were achieved without any next day impairment of cognition or coordination. Arena is currently evaluating the effects of APD125 on patients' subjective assessment of sleep in a Phase IIb study.

• BioLineRx Ltd., of Jerusalem, Israel, has begun a Phase IIb trial to assess the efficacy, safety and tolerability of BL-1020, a GABA-enhanced antipsychotic for the treatment of schizophrenia. In the six-week, double-blind, parallel group study, patients will be randomized to one of four arms, receiving a low dose or high dose of BL-1020; risperidone, an approved atypical schizophrenia drug; or placebo. The study will also include a blinded six weeks continuation phase. It is expected to include 360 schizophrenia patients and is being conducted under an FDA investigational new drug application.

• Calando Pharmaceuticals Inc., of Pasadena, Calif., said it has entered into a collaboration with City of Hope in Duarte, Calif., to initiate an investigator sponsored clinical trial using Calando's nanoparticle drug candidate, IT-101, in patients with various forms of lymphoma. The trial will be an open-label, Phase II study of IT-101 intended to demonstrate safety and efficacy in patients with relapsed or refractory lymphoma, including B cell, T cell and Hodgkin's lymphoma who satisfy eligibility requirements.

• ChemoCentryx Inc., of Mountain View, Calif., said it has completed enrollment of 436 patients in PROTECT-1, a Phase II/III clinical trial of Traficet-EN (CCX282-B) in patients with moderate-to-severe Crohn's disease. The trial comprises three discrete phases that allows for evaluation of efficacy and safety of Traficet-EN in inducing a clinical response or remission and maintaining response-remission in Crohn's disease over one year. Traficet-EN is an orally-active inhibitor of the chemokine receptor known as CCR9, which is selectively expressed by inflammatory T cells to migrate to the digestive tract in a process that ultimately results in the persistent inflammation underlying the disease.

• Cytomedix Inc., of Rockville, Md., said it plans to enter the multi-billion dollar anti-inflammatory market with patent protected peptides derived from platelet factor 4 (PF4), a growth factor released when blood platelets are activated. Preclinical studies indicate that the company's CT-112 peptide may be active for the treatment of inflammatory diseases such as rheumatoid arthritis, Crohn's disease, tissue reperfusion injury and other autoimmune diseases, the company said. The studies also indicated that CT-112 may be administered orally, unlike other anti-inflammatory drugs currently on the market which are administered via injection.

• GenVec Inc., of Gaithersburg, Md., announced encouraging results from its Phase I/IIa clinical trial sponsored by the Naval Medical Research Center and the U.S. Military Malaria Vaccine Program showing that its malaria vaccine candidate induced strong T-cell responses against the target antigens in all volunteers. The vaccine is designed to provide protection against both liver and blood stages of the malaria parasite. NMRC is planning to evaluate the protective effects of the vaccine following experimental challenge with Plasmodium falciparum parasites that cause malaria in the second half of the study.

• Geron Corp., of Menlo Park, Calif., said newly presented data indicate that GRNCM1, the company's human embryonic stem cell (hESC)-based therapeutic for the treatment of heart failure, evades direct attack by the human immune system in vitro. Unlike whole organ transplants, cell therapies derived from hESCs may provoke only minimal immune reactions suggesting that rejection may be controlled or prevented by short courses of low-dose immunosuppressive drugs, according to data presented at the International Society for Stem Cell Research annual meeting. The work also suggests that patient-specific hESC lines may not be needed to prevent immune rejection.

• Human Genome Sciences Inc., of Rockville, Md., said the results from a long- term Phase II continuation trial showed that LymphoStat-B (belimumab) was associated with sustained improvement in disease activity across multiple clinical measures, decreased frequency of disease flares, potential steroid-sparing activity, and was generally well tolerated through three years on treatment in combination with standard of care in patients with serologically active systemic lupus erythematosus. The overall incidence of adverse events (in general and by system organ class), serious adverse events, infections, malignancies and laboratory abnormalities continued to decrease or stabilize from Week 52 to Week 160.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported positive Phase I/II data for IDX899, a non-nucleoside reverse transcriptase inhibitor being developed for the treatment of HIV-1 confirming potent antiviral activity and favorable safety profile in treatment-naive HIV-infected patients. No treatment-related serious adverse events were reported for any of the patients receiving IDX899 and no patients discontinued the study. Also, there were no discernable patterns in adverse events between treatment groups and there were no laboratory abnormalities during the treatment period.

• Incyte Corp., of Wilmington, Del., presented positive results from a 28-day Phase IIa trial of INCB18424, its orally available janus-associated kinase inhibitor, in patients with rheumatoid arthritis. Results from the first of four treatment groups, involving 12 treated and 4 placebo patients, demonstrated that the 15 mg twice-daily dose was well tolerated and provided ACR20/50/70/90 response rates of 75 percent/50percent/25percent/17 percent, respectively, with responses seen as early as one week. These results suggest that INCB18424 has the potential to be more effective than currently available RA therapies, including the widely used injectable biologicals.

• Iomai Corp., of Gaithersburg, Md., said data from the company's positive Phase II field study of its travelers' diarrhea vaccine were published online and in the June 14, 2008, edition of The Lancet. The study analyzed data from 170 travelers and found that those who received the Iomai patch-based vaccine were statistically significantly less likely to suffer from clinically significant diarrhea than their counterparts who received a placebo. The study found that of the 59 individuals who received the patch-based vaccine, only three suffered from moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered from moderate or severe diarrhea, a 75 percent reduction (p=0.007).

• MethylGene Inc., of Montreal, said the first patient was dosed in a Phase I trial evaluating MGCD265 in solid tumors (Trial 101). This is the second Phase I trial with the compound which is being evaluated on different dosing schedules. In this dose-escalating Phase I trial, MGCD265 is administered orally to patients at an initial starting dose of 24 mg/m2 daily on a continuous basis for a 21-day cycle. The purpose of this trial is to evaluate the safety, pharmacokinetics, pharmacodynamics, and the maximum tolerated dose of MGCD265 in patients with advanced metastatic or unresectable solid tumors that are refractory to standard therapy.

• Micromet Inc., of Bethesda, Md., and Medimmune Inc., of Gaithersburg, Md., said that the first patient has started treatment in a multi-center, Phase II trial conducted in Germany investigating BiTE antibody blinatumomab (MT103/MEDI-538) in patients with adult acute lymphoblastic leukemia (ALL), a very aggressive form of B cell leukemia. Blinatumomab is a T cell engaging antibody targeting the CD19 antigen, which is only expressed on B cells. This Phase II trial recruits ALL patients with low number of residual tumor cells in their bone marrow after chemotherapy and will test whether blinatumomab can eliminate residual tumor cells and prolong the time to relapse.

• Opexa Therapeutics Inc., of The Woodlands, Texas, said data showed that 27.3 percent of patients receiving Tovaxin, an investigational T-cell vaccination therapy for multiple sclerosis, demonstrated sustained improvement, 59.1 percent had no disease progression and 13.6 percent experienced sustained worsening of disability. During the two-year study period, 72.7 percent of patients remained relapse-free. Tovaxin was well-tolerated throughout the two-year study period. The safety profile revealed only mild-to-moderate injection site reactions and no serious adverse reactions related to T-cell vaccination.

• OPKO Health Inc., of Miami, Fla., said it has acquired exclusive worldwide rights to a novel small molecule agent in Phase II clinical development for the treatment of viral conjunctivitis and other viral infections. The agent, CTC-96, also known as Doxovir, was developed by Redox Pharmaceutical Corp., of New York. It is a member of a novel drug class that has demonstrated potent anti-viral activity and non-steroidal anti-inflammatory properties with good safety in preclinical and human clinical testing. OPKO expects to initiate in the coming months Phase II trials assessing CTC-96 for the treatment of viral conjunctivitis. Financial terms were not disclosed.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., said Phase IIb data in heavily treatment-experienced patients demonstrated that functional monotherapy with bevirimat, its oral HIV maturation inhibitor, resulted in a mean viral load reduction of 1.26 log10 in patients who had these response predictors and a threshold bevirimat concentration of 20 ug/mL. In the study, 44 heavily treatment-experienced patients were given bevirimat for 14 days as functional monotherapy in escalating dose groups. Data were presentedat the International HIV Drug Resistance Workshop in Sitges, Spain.

• Pharmaxis, of Sydney, Australia, said it has completed a 12-month Phase III trial evaluating the safety of Bronchitol in 100 subjects with bronchiectasis. This 12-month treatment period was an open label extension to a three-month efficacy trial which showed that Bronchitol improved quality of life and mucus clearance. The objective of the open label extension is to determine the adverse event profile of Bronchitol following prolonged use. Results of the trial will be reported in July.

• PTC Therapeutics Inc., of South Plainfield, N.J., said results from an Israeli Phase IIa extension study evaluating three months of oral PTC124 treatment in adult patients with nonsense-mutation-mediated cystic fibrosis demonstrated statistically significant improvements in the function of the cystic fibrosis transmembrane conductance regulator protein CFTR and a statistically significant mean, 28 percent, decrease in the frequency of cough, one of the most prominent and burdensome CF-related symptoms. Separately, results from a European study evaluating 14-day courses of PTC124 in pediatric patients with nonsense-mutation-mediated CF confirmed the CFTR activity observed in previous short-term studies in adult patients.

• Repligen Corp., of Waltham, Mass., said it plans to initiate a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder later this year. The 150-patient multicenter, parallel arm placebo-controlled, clinical trial will assess the efficacy and safety of RG2417 on the symptom of depression as measured by the Montgomery-Asberg Depression Rating Scale.

• Rigel Pharmaceuticals Inc., of South San Francisco, has begun two Phase IIb trials of its orally bioavailable Syk inhibitor, R788 (fostamatinib disodium), in patients with rheumatoid arthritis. The trials will evaluate the efficacy of R788 compared to placebo in distinct RA patient groups. Results of the clinical trials are expected to be available in late 2009.

• Somaxon Pharmaceuticals Inc., of San Diego, presented new subset of data from its completed Phase III clinical development program, which comprised four Phase III trials, evaluating SILENOR, a low-dose formulation of doxepin, for the treatment of insomnia. The new analysis showed that elderly subjects with chronic insomnia taking SILENOR experienced consistent symptom improvement beyond the traditional analyses of quantitative nighttime sleep. Doxepin was well-tolerated in both studies, with side effect profiles comparable between groups, no reports of complex sleep behaviors, amnesia or anticholinergic effects and no next-day residual effects.

• Tengion Inc., of East Norriton, Pa., said the results of a preclinical study of its Neo-Bladder Augment will be featured in the July issue of the Journal of Urology. Key findings of the preclinical trial. show that the Tengion Neo-Bladder Augment restored baseline urodynamics as early as six months after implantation and led to a structurally and functionally complete regenerated bladder wall as early as nine months. In contrast, scaffold implants alone failed to return to urodynamic baseline by the study termination and failed to regenerate a complete bladder wall.

• Tolerx, of Cambridge, Mass., said its lead drug otelixizumab showed remission rates of up to 68 percent in non-obese diabetic mice with new onset of Type I diabetes at five separate doses (5-50 mg). The data showed that T-cell receptor modulation levels varied and reflected drug administration, but did not predict efficacy of treatment. Efficacy is likely dependent on initial beta-cell mass present in new onset diabetic NOD mice, Tolerx said. Tolerx also said otelixizumab showed induction of T regulatory cells, characterized as CD4+FoxP3+ in vitro 7 days after antibody treatment. The increase of T regulatory cells seen in vitro was also seen in vivo in subjects dosed with otelixizumab.

• Transcept Pharmaceuticals Inc., of Port Richmond, Calif., said data showed that within 20 minutes of administration, Intermezzo, a low-dose sublingual formulation of zolpidem, delivered overall bioavailability that was significantly greater than that product by a swallowed Ambien tablet containing a zolpidem dose that was nearly three times higher. Results also showed that, despite that higher bioavailability, subjects receiving Intermezzo had significantly lower zolpidem blood levels four hours after administration compared to those who received the 10 mg Ambien dose. The study involved 36 healthy subjects randomized to receive Intermezzo or Ambien following an overnight fast.