(BioWorld Today Via Acquire Media NewsEdge) , of Los Angeles, presented preliminary results from a single-arm, open-label, Phase II trial evaluating Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine and epirubicin for the treatment of patients with locally advanced breast cancer (neoadjuvant treatment). In the preliminary analysis, 18 percent of patients (n = 23) given a regimen of Abraxane (nab-paclitaxel), gemcitabine and epirubicin achieved a complete pathologic response, and 68 percent (n = 84) achieved a partial response. Data were presented at the San Antonio Breast Cancer Symposium.

? Aposense Ltd., of Petach-Tikva, Israel, reported the initiation of a Phase II, multicenter study of its [18F]-ML-10 compound for molecular imaging of apoptosis at Memorial Sloan-Kettering Cancer Center, following approval by its institutional review board. This study aims to evaluate the safety and efficacy of [18F]-ML-10 in early assessment of response of metastatic brain tumors to high-dose, single-fraction radiotherapy. The study endpoints include assessment of apoptotic changes occurring within days after treatment, and the accuracy of those changes in predicting treatment results.

? BioTheranostics, of Cambridge, Mass., reported findings from three studies using its molecular breast cancer assay to predict risk of disease recurrence in individual patients. One study compared breast cancer risk recurrence stratification by Oncotype DX vs. Theros Breast Cancer Index and found that using the combined H/I-MGI biomarkers (Theros BCI) to assess risk recurrence resulted in a smaller intermediate risk group than OncoType Dx (18 percent vs. 47 percent, respectively). Another study found that the Theros BCI identified, among patients with early stage breast cancer, those with a higher risk of treatment failure when treated only with hormonal therapy. Data were presented at the San Antonio Breast Cancer Symposium.

? Cylene Pharmaceuticals, of San Diego, said it initiated a Phase II trial of quarfloxin (CX-3543), a small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs, in patients with carcinoid/neuroendocrine tumors (C/NET), which are malignant cancers arising from neural crest cells. The study will include an assessment of improvements in patients' symptoms and biochemical markers, in addition to RECIST tumor response measurements.

? Hawaii Biotech Inc., of Aiea, Hawaii, said it completed dosing of healthy subjects in a multiple-dose safety study of its West Nile virus vaccine. The company expected to have preliminary safety results and immunologic data in early 2009, with complete results by third-quarter 2009.

? Kamada Ltd., of Ness Ziona, Israel, said it completed patient enrollment in its Phase II trial of inhaled Alpha-1 Antitrypsin (AAT) delivered via the eFlow nebulizer system (PARI Pharma Gmbh) in patients with bronchiectasis. A total of 21 patients were randomized to receive either inhaled AAT or placebo, and the purpose of the study is to investigate safety and efficacy. The product has orphan drug designation for bronchiectasis, and Kamada also is testing it in AAT deficiency and cystic fibrosis.

? KeyNeurotek Pharmaceuticals AG, of Magdeburg, Germany, said patient recruitment for its European Phase IIa study of KN38-7271-001 in traumatic brain injury has been completed on schedule. The study will investigate the safety and tolerability, in addition to therapeutic efficacy signals, of KN38-7271. Results of the study are expected in summer 2009.

? Ortho Biotech Products LP, of Bridgewater, N.J., reported that results from a Phase III study showed that patients with metastatic breast cancer who were treated previously with an anthracycline in the adjuvant setting experienced a significant improvement in time to disease progression and overall response rates after receiving a combination of Doxil (doxorubicin HCl liposome injection) and docetaxel as compared to docetaxel alone. The study found that patients treated with the Doxil and docetaxel combination had a 35 percent risk reduction for developing disease progression compared with docetaxel alone (hazard ratio = 0.65; 95 percent confidence interval [0.55, 0.77]; p = 0.000001). There is an almost three-month improvement in median time to progression for patients treated with the combination compared with docetaxel monotherapy (9.8 vs. seven months, respectively). Data were presented at the San Antonio Breast Cancer Symposium.

? QRxPharma Ltd., of Sydney, Australia, said it started a comparative study to test MoxDuoIR, a combination of morphine and oxycodone, against equivalent analgesic doses of morphine and oxycodone alone in acute moderate to severe pain. The primary endpoints focus on pain relief and intensity scores of MoxDuoIR vs. equivalent doses of morphine and oxycodone during the first 24 hours following surgery. Secondary endpoints include efficacy relating to the time to onset of analgesia and global assessment of effect, as well as measuring the incidence and intensity of opioid-related adverse events. Data collected from that 180-patient trial will be used to support final Phase III studies required for new drug application submission. QRxPharma expects to complete dosing prior to the second quarter of 2009.

? Theratechnologies Inc., of Montreal, reported 52-week results of its confirmatory Phase III trial, evaluating the long-term safety profile of its lead compound, tesamorelin, in patients with HIV-associated lipodystrophy. The results showed are consistent with the safety profile observed in the first Phase III trial. In addition, patients lost 18 percent of their visceral adipose tissue after 52 weeks of treatment, while losing 11 percent after 26 weeks of treatment, compared to baseline. Theratechnologies plans to use the data for a new drug application to the FDA.

? Tibotec Pharmaceuticals Ltd., of Cork, Ireland, said it is recurring HIV-positive, treatment-na?ve adults in Europe for two Phase III trials of TMC278, a non-nucleoside reverse transcriptase inhibitor. The studies will compare TMC278, given as a once-daily oral tablet, to Sustiva (efavirenz, Bristol-Myers Squibb Co.), when administered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs). The first Phase III trial will use a fixed background regimen consisting of emtricitabine and tenofovir disoproxil fumarate, while the second pivotal study will involve an investigator-selected background regimen consisting of two N[t]RTIs, either abacavir plus lamivudine or emtricitabine plus tenofovir disoproxil fumarate or zidovudine plus lamivudine. The trials are expected to enroll about 680 patients, and the primary endpoint is to assess the proportion of patients with a confirmed plasma viral load of less than 50 HIV-1 RNA copies/mL at week 48.

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