• Affymax Inc., of Palo Alto, Calif., said it has begun enrollment for a Phase II trial of Hematide to correct anemia in patients with chronic renal failure who are undergoing dialysis and are not actively being treated with an erythropoiesis stimulating agent (ESA) in a prior 12-week period. The primary objective is to evaluate the safety, efficacy and dose response to Hematide, a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and acts as an ESA, administered once per month. Enrollment in this trial is expected to be completed by year end.

• Antisense Therapeutics Ltd., of Melbourne, Australia, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said ATL/TV1102, an antisense drug, significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis. A randomized, double-blind, placebo-controlled Phase IIa study met its primary endpoint showing a significant reduction by 54.4 percent (p = 0.01) in a cumulative number of new active lesions in patients taking ATL/TV1102 for eight weeks, compared to placebo, as measured by magnetic resonance images. Based on those results, Teva said it intends to conduct additional preclinical and clinical research before continuing to a Phase III study with the molecule.

• Aradigm Corp., of Hayward, Calif., announced positive results from an open-label, two-week efficacy and safety Phase II study of its once-daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis. The primary efficacy endpoint was the change from baseline in the sputum Pseudomonas aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load. The data showed that Pseudomonas CFU was decreased significantly over the 14-day treatment period and continued to decrease one week after treatment was discontinued without the need of additional antibiotic use. The drug was well tolerated, and there were no serious adverse events reported during the trial.

• ArGentis Pharmaceuticals LLC, of Memphis, Tenn., reported Phase II results of ARG201 (highly purified Type 1 bovine collagen) in diffuse cutaneous systemic sclerosis, which showed that late-phase patients had a statistically and clinically significant decrease from baseline in modified-Rodnan Skin Scores (-7.9 units) in the collagen-treated patients vs. placebo. There was no difference in skin scores in early phase patients, though subsequent analysis demonstrated that those who were diagnosed as early as 1.75 years diagnosis might benefit from Type 1 collagen therapy. Those data were published in the June 2008 issue of Arthritis & Rheumatism.

• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., has begun enrollment for its randomized, double-blind, placebo-controlled U.S. Phase II clinical trial evaluating CPP-109 for the treatment of patients addicted to methamphetamine. CPP-109, an orally administered, small-molecule drug, which inhibits psychostimulant-induced dopamine release, is Catalyst's version of vigabatrin.

• Cytokinetics Inc., of of South San Francisco, reported what it called encouraging results of a Phase Ib trial to evaluate ispinesib in combination with capecitabine, an oral chemotherapy agent commonly used in the treatment of breast cancer. Although a single-dose regimen was not formally confirmed as the optimally tolerated regimen, ispinesib administered at 18 mg/m2, its maximum tolerated dose as monotherapy, was well tolerated in combination with doses of capecitabine at daily doses of 2,000 mg/m2 and 2,500 mg/m2. Investigators concluded that the combination of ispinesib with capecitabine had an acceptable tolerability profile on the 21-day schedule investigated. The dose limiting toxicity in that combination regimen was consistent with the monotherapy toxicities of ispinesib (prolonged neutropenia) and capecitabine (rash). The best response observed among the 24 patients treated was a partial response by Response Evaluation Criteria In Solid Tumors (RECIST) in a patient with advanced breast cancer. In addition, 11 patients had a response of stable disease by RECIST. The trial is being conducted by partner GlaxoSmithKline plc, of London.

• DeCode Genetics, of Reykjavik, Iceland, announced positive topline results from its latest clinical pharmacology study of DG041, the company's first-in-class antagonist of the EP3 receptor for prostaglandin E2, being developed as a next-generation oral antiplatelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current antiplatelet treatment, Plavix (clopidogrel) and aspirin. The results confirmed previous clinical findings that DG041 inhibits platelet aggregation without increasing bleeding time as monotherapy, and demonstrated that in combination with clopidogrel alone, as well as with clopidogrel and aspirin, DG041 provided additional antiplatelet effect without prolonging bleeding time.

• Emisphere Technologies Inc., of Cedar Knolls, N.J., said Novartis Pharma AG, of Basel, Switzerland, launched a Phase I study in postmenopausal women to determine the safety and tolerability of oral PTH134, a combination of human PTH-1-34 and the absorption enhancer 5-CNAC using Emisphere's proprietary Eligen technology, for the treatment of postmenopausal osteoporosis. The study is to assess the bioavailability profile of increasing doses of PTH-1-34 combined with different amounts of 5-CNAC administered orally. The trial is being conducted in Switzerland and is estimated to yield first interpretable results by the end of the year.

• Epigenomics AG, of Berlin, said enrollment of the first subjects in the PRESEPT study has begun. The trial of up to 7,500 asymptomatic subjects will evaluate the clinical performance of Epigenomics' biomarker, Septin 9, for colorectal cancer population wide screening of guideline-eligible individuals. Epigenomics hopes to demonstrate that colorectal cancer early detection with a blood test based on Septin 9 will meet the requirements of current U.S. screening guidelines for noninvasive screening tests.

• EUSA Pharma, of Oxford, UK, said new data show that use of Caphosol, an advanced oral electrolyte solution, resulted in both favorable impact on rates and severity of oral mucositis in cancer patients undergoing chemotherapy and radiation therapy. The data, presented at the International Symposium of the Multinational Association of Supportive Care in Cancer in Houston, also demonstrate that Caphosol use is associated with low use of pain medication and high levels of patient and physician satisfaction.

The GI Co., of Framingham, Mass., said a Phase II study to evaluate the safety and efficacy of its lead clinical compound, Intestinal Trefoil Factor (rhITF) Oral Spray, in development for oral mucositis, met both primary and secondary endpoints. The primary endpoint was the World Health Organization Scale and the secondary endpoint was OMAS score, a quantification tool that enables physicians to quantitate mucosal tissue damage. Mean OMAS scores were consistently and significantly lower in the low- and high-dose rhITF treatment arms compared to placebo over days seven to 14, post-chemotherapy and showed significant reduction in the frequency of grade greater than or equal to 2 oral mucositis in 99 colorectal cancer patients at high risk for developing chemotherapy-induced oral mucositis.

• Inovio Biomedical Corp., of San Diego, said its partner, Tripep AB, of Huddinge, Sweden, reported additional interim results from its ongoing Phase I/II study of its ChronVac-C therapeutic DNA vaccine, which is delivered using Inovio's electroporation-based DNA delivery system. Results from the first two patients in the intermediate dose group to complete treatment against hepatitis C virus infection, from samples taken before, during and after treatment, showed that the viral levels in blood decreased up to 87 percent and 98 percent, respectively, during treatment. ChronVac-C is a vaccine given to individuals already infected with the hepatitis C virus with the aim of clearing the infection from the liver by boosting the body's immune response against the virus.

• NuPathe Inc., of Conshohocken, Pa., reported positive Phase I results of NP101, a drug-device patch for acute migraine, which showed that, in 23 healthy volunteers, plasma concentrations for NP101 were more consistent compared to Imitrex (GlaxoSmithKline), administered as either the 20-mg nasal spray or as the 100-mg tablet formulation. NP101, which combines NuPath's SmartRelief iontophoretic transdermal technology with sumatriptan, also was well tolerated. Those results were presented at the American Headache Society meeting in Boston.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., has begun patient screening and dosing in a Phase II trial to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with non-small-cell lung cancer (NSCLC). The primary objective is to assess the overall response rate to the combination of bavituximab with a standard regimen of carboplatin and paclitaxel in NSCLC patients. The multicenter clinical trial is being conducted in India.

• Repros Therapeutics Inc., of The Woodlands, Texas, said two clinical sites were initiated for a Phase IIb study monitoring the effects of its oral drug Androxal on male fertility and testicular function in patients being treated for low testosterone as compared to Testim (Auxilium Pharmaceuticals Inc.), a popular marketed topical testosterone medication. The study plans to enroll 24 patients with secondary hypogonadism that have been treated with topical testosterone for at least six months but not more than two years. The primary endpoints will be the change in semen volume, sperm count and motility from baseline comparing the Androxal and Testim groups. Secondary endpoints will consist of changes in pituitary hormones as well as testosterone.

• SGX Pharmaceuticals, of San Diego, said it submitted an investigational new drug application to the FDA for SGX393, a selective, orally bioavailable small molecule for the treatment of relapsed and refractory chronic myelogenous leukemia (CML). It is being developed for patients who relapse or are intolerant to Gleevec (imatinib), which have been linked to drug-resistant mutant forms of the tyrosine kinase BCR-ABL. SGX393 inhibits both wild-type BCR-ABL and many drug resistant mutant forms of BCR-ABL, including the T315I mutation.

• Sinovac Biotech Ltd., of Beijing, has begun volunteer enrollment in its Phase II trial for its split pandemic influenza vaccine. Preliminary results are expected to be available in early 2009. The randomized and double-blind trial is expected to enroll 210 adolescents, between the ages of 12 to 17, who will receive doses of 10 ug, 15 ug or 30 ug, and 140 children, between the ages of 3 to 11, who will receive doses of 10 ug or 15 ug. Volunteers will be followed for two months with safety and immunogenicity data collected for the assessment of the vaccine.

• TorreyPines Therapeutics Inc., of La Jolla, Calif., said data showed the company's lead AMPA/kainate-type glutamate receptor antagonist, tezampanel, met the primary endpoint of headache pain relief at two hours and demonstrated improvement in secondary endpoints in a 306-patient Phase IIb clinical trial in acute migraine headache. Tezampanel demonstrated improvement in sustained headache response, absence of nausea or vomiting, absence of phonophobia and absence of photophobia. It was well tolerated with no reports of serious or medically important adverse events. Data were presented at the annual Scientific Meeting of the American Headache Society in Boston.

• XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y., announced the completion of the randomization of 350 patients in a Phase IIb trial of Bicifadine, a serotonin and norepinephrine reuptake inhibitor (SNRI). The randomized, double-blind, placebo-controlled study is aimed at demonstrating the efficacy of Bicifadine in diabetic neuropathic pain, using a study design similar to Cymbalta (Eli Lilly & Co.), another SNRI approved for this indication. Outcome of the study is expected in Q4 of this year.

• Zogenix Inc., of Seattle, said a study of healthy adult subjects showed, sumatriptan DosePro, a migraine medication under development, was bioequivalent to the needle-based autoinjector in the abdomen and thigh injection sites, and showed that maximum plasma concentrations of sumatriptan were reached rapidly, within approximately 12 minutes. An early time to peak plasma concentration for migraine drugs is important because it has been shown to correlate with speed and completeness of the response to symptoms of migraine headache. Sumatriptan DosePro and Imitrex Statdose treatments also exhibited highly similar safety profiles. A home-based study demonstrated that 98 percent of patients were able to correctly use the DosePro technology on their first try, even in the midst of an acute migraine attack.