Advaxis Inc., of Princeton, N.J., presented updated data at the Society for Immunotherapy of Cancer meeting in North Bethesda, Md., from its ongoing 110-patient Phase II trial testing ADXS-HPV vs. ADXS-HPV plus cisplatin in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. As of Oct. 22, landmark survival at six months, nine months, 12 months and 18 months was 65 percent, 44 percent, 33 percent and 17 percent, respectively, with no apparent

Asahi Kasei Pharma America Corp., of Waltham, Mass., said it started an 800-patient Phase III trial of ART-123 (recombinant human thrombomodulin, sold as Recomodulin in Japan) in severe sepsis patients with coagulopathy. The study is designed to measure 28-day all-cause mortality as its primary efficacy endpoint; primary safety measures include serious adverse events, adverse events and major bleeding events. Secondary endpoints include all-cause mortality at three months and resolution of

AB Science SA, of Paris, reported Phase III results showing that masitinib in combination with Gemzar (gemcitabine, Eli Lilly and Co.) significantly extended overall survival in patients with pancreatic cancer by six months and 2.7 months in two independent patient populations, representing 65 percent and 45 percent of the overall population – namely, patients with a genetic biomarker indicative of aggressive disease progression. AB Science also said the European Medicines Agency accepted for

Bioheart Inc., of Sunrise, Fla., said it will start its ANGEL trial in Mexico and said NorthStart Biotech LLC, a consortium of Bioheart directors and shareholders, agreed to fund the study, which will test the safety and efficacy of LipiCell (adipose-derived stem cells) in congestive heart failure patients. The first cohort of five patients will be completed and analyzed to help establish a safety profile and preliminary efficacy. Cellceutix Corp., of Beverly, Mass., said it has recruited the

AstraZeneca plc, of London, said it started a Phase III study, dubbed FALCON, to compare fulvestrant to Arimidex (anastrozole) in hormone therapy-naïve postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer. The study is expected to involve 450 women and will evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg.

Biogen Idec Inc., of Weston, Mass., reported in its third-quarter earnings call that it will not proceed with a planned Phase IIa rheumatoid arthritis (RA) study of its Syk inhibitor partnered with Portola Pharmaceuticals Inc., of South San Francisco. Biogen said the compound did not meet the "stringent target product profile to be competitive in this specific market." The companies, which entered the potential $553.5 million Syk collaboration last year, will continue exploratory work in

Daiichi Sankyo Co. Ltd., of Tokyo, said it completed patient enrollment in the Hokusai-VTE Phase III study testing once-daily oral Factor Xa inhibitor edoxaban for the treatment and prevention of recurrence of venous thromboembolism in patients who have had an acute symptomatic deep vein thrombosis, pulmonary embolism or both.

Cytori Therapeutics Inc., of San Diego, said two independent investigator-sponsored and funded cell therapy clinical trials in Japan have been approved. One study will investigate Cytori's cell therapy as a treatment for ischemic heart failure and the other for cirrhosis of the liver. In each study, patients will receive an injection of Cytori's cell therapy, which consists of the patient's own adipose-derived stem and regenerative cells (ADRCs) processed using Cytori's Celution system. The

Teva Pharmaceutical Industries Ltd., of Jerusalem, said its women's health subsidiary reported Phase III findings showing that Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an extended-regimen oral contraceptive, showed the product is efficacious for the prevention of pregnancy and has a safety profile similar to those of other oral contraceptives. Data were presented at the American Society of Reproductive Medicine meeting in San Diego.

Abbott, of Abbott Park, Ill., said results from a post-hoc subanalysis of the 52-week Humira (adalimumab) ULTRA 2 study showed clinically meaningful rates of mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis who failed, were intolerant or had contraindications to certain other medications and achieved a response to Humira induction therapy at eight weeks. Of the 494 patients included in the analysis and who responded at eight weeks, significantly more

Abbott, of Abbott Park, Ill., said results from three-year long-term data from an ongoing extension study of the Humira (adalimumab) ULTRA 1 and ULTRA 2 studies in ulcerative colitis showed a reduction in observed mean Partial Mayo score from 5.9 at the time of first Humira dose to 1.4 at week 172. A 55.3 percent remission rate, per Partial May score, at week 60 of the extension study also was seen. Data were presented at the American College of Gastroenterology meeting in Las Vegas. Eli

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Aeterna Zentaris Inc., of Quebec City, said its ghrelin agonist, AEZS-130, showed potential as an oral diagnostic test for adult growth hormone deficiency, and that its accuracy is comparable to currently available tests. The study and its results were presented at the International Congress of the Growth Hormone Research and Insulin-like Growth Factor Society in Munich, Germany. Curis Inc., of Lexington, Mass., achieved the first two development milestones related to its agreement with the

Chiesi Group, of Parma, Italy, said it completed a Phase I trial of inhaled PDE4 inhibitor CHF 6001 that showed the drug was well tolerated up to the highest doses administered, in single and multiple dose parts of the study. Based on those data, two Phase IIa studies are ongoing in patients with asthma and chronic obstructive pulmonary disease. Pfizer Inc., of New York, said it completed a study to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg twice daily compared to

Amgen Inc., of Thousand Oaks, Calif., presented data at the American Society for Bone and Mineral Research meeting in Minneapolis, including results from the open-label extension study of the pivotal Phase III trial of Prolia (denosumab), which showed continued increases in bone mineral density (BMD) and low fracture incidence over six years. Data demonstrated that nearly all women who received six years of treatment with the RANK ligand-targeting drug showed gains in BMD at the lumbar spine

Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). The anti-diuretic effect of desmopressin melt correlated strongly with reduced PLMS, with 90 percent of children in the study experiencing reduced PLMS. Data were presented at the Joint Congress of the International Children's

Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a Phase I trial of APD811, an oral drug candidate designed to target the prostacyclin receptor for the treatment of pulmonary arterial hypertension. The dose-titration study is planned to enroll up to 30 healthy adult volunteers and will evaluate safety, tolerability and pharmacokinetics of multiple ascending doses. Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the

Pfizer Inc., of New York, disclosed top-line Phase III data from an open-label long-term safety study of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, noncancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release

Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells. Euthymics Bioscience Inc