• Aesgen Inc., of Princeton, N.J., said pivotal Phase III data showed Saforis (L-glutamine) for oral suspension significantly reduced the severity and duration of clinically significant oral mucositis in breast cancer patients receiving standard chemotherapy treatments. The data reinforced earlier results showing Saforis reduced the severity and duration of oral mucositis and the need for narcotic pain control in cancer patients undergoing chemotherapy or radiation therapy.

• Allos Therapeutics Inc., of Westminster, Colo., said Phase III data of RSR13 (efaproxiral) in patients with brain metastases showed that the concentration of RSR13 in the red blood cells of patients treated with whole-brain radiation therapy clearly correlated with improvement in survival. Patients who achieved optimal RSR13 levels had better clinical outcomes than patients who did not.

• Amgen Inc., of Thousand Oaks, Calif., and Abgenix Inc., of Fremont, Calif., said interim data from an ongoing Phase II study demonstrated that panitumumab (formerly ABX-EGF) has antitumor activity when administered as a single agent to patients with metastatic colorectal cancer who have failed chemotherapy. Patients with measurable metastatic colorectal cancer that expressed the epidermal growth factor receptor experienced partial responses. Also, Amgen said Aranesp when used in treating anemia in cancer patients not undergoing chemotherapy may improve hemoglobin levels, reduce the need for transfusion and improve fatigue experienced by patients.

• AnorMed Inc., of Vancouver, British Columbia, said AMD3100, its lead candidate for stem cell transplantation, helped multiple myeloma patients who previously had failed to collect enough stem cells, to undergo tandem stem cell transplantation. In the Phase II study, AMD3100 combined with G-CSF improved cell collection in seven out of 10 patients, making them eligible for transplant, AnorMed said.

• Antigenics Inc., of New York, said a total of 644 patients have been randomized in the Phase III trial of its cancer vaccine Oncophage in renal-cell carcinoma. It also reported Phase II data from an Oncophage combination treatment trial in metastatic melanoma showing that 10 of 16 patients experienced disease stabilization. Researchers concluded that the immunological and clinical responses induced by Oncophage given in combination with GM-CSF and IFN-alpha did not appear to be significantly superior to those mediated by vaccination with Oncophage alone.

• Aphton Corp., of Miami, said Phase III data of G17DT as a monotherapy for patients with advanced pancreatic cancer who are unable to tolerate or unwilling to take chemotherapy showed the product prolonged survival with statistical significance.

• Aphton Corp., of Miami, said Phase II data of G17DT Immunogen in combination with irinotecan-based chemotherapy in patients with irinotecan-refractory metastatic colorectal cancer showed a median survival for all patients of 229 days. Immune responders (62 percent) lived significantly longer than patients who were not immune responders. The best overall tumor response rate was 3 percent (partial responses), and the addition of G17DT did not exacerbate the toxicity profile of irinotecan. Aphton also said a Phase II study of G17DT in combination with cisplatin and 5-fluorouracil in chemotherapy-na ve patients with locally recurrent or metastatic gastric and gastroesophageal cancer showed an overall tumor response rate of 51 percent. Patients treated with the combination had a median survival of 8.9 months, and those who developed G17 antibodies had a median survival of 10.8 months.

• Biogen Idec Inc., of Cambridge, Mass., said Zevalin may produce high complete remission rates in previously untreated patients with low-grade follicular lymphoma when used following Rituxan and a short course of CHOP chemotherapy.

• Biomira Inc., of Edmonton, Alberta, said an exploratory analysis showed a statistically significant survival advantage for women in the hormonal therapy subset of patients receiving Theratope vaccine as part of the company's Phase III study to treat metastatic breast cancer. The overall survival for patients in the hormonal subset now shows a statistically significant difference between the two treatment arms - women in the Theratope arm survived a median of 36.5 months, while those in the control arm survived a median of 30.7 months.

• Celgene Corp., of Warren, N.J., said Phase III data showed thalidomide plus dexamethasone in multiple myeloma compared with dexamethasone monotherapy showed a statistically significant difference in response rates of 59 percent vs. 41 percent at four months. The study enrolled 207 patients, with 103 randomized to the thalidomide/dexamethasone group. The combination group experienced more side effects, including deep-vein thrombosis, rash, sinus bradycardia and neuropathy.

• Cell Genesys Inc., of South San Francisco, said GVAX for acute myelogenous leukemia showed it was well tolerated and may reduce residual leukemic cells that persist after chemotherapy as indicated by decreased levels of WT-1. Patients with newly diagnosed leukemia were treated with chemotherapy, and if responsive, received autologous bone marrow stem cell transplantation and GVAX leukemia vaccine.

• Cell Therapeutics Inc., of Seattle, said Phase III trials of Xyotax in non-small-cell lung cancer showed higher than predicted survival rates, meaning the primary efficacy analysis and data release will not occur until early 2005. Separately, it said Trisenox (arsenic trioxide) injection in 67 patients with myelodysplasia was active in both low- and high-risk disease. Among 62 evaluable patients in the Phase II trial, six of 29 low-risk patients achieved a major hematologic response and four of the 33 high-risk patients achieved a major response.

• Cel-Sci Corp., of Vienna, Va., said Phase II data in 19 of 39 head and neck cancer patients using Multikine prior to surgery and radiation showed that treatment with the compound caused a significant shift in the ratio of key immune cells that infiltrate the tumor. Patients treated with Multikine had a much higher rate of tumor-cell killing, resulting in a 42 percent overall response rate, including 12 percent complete responses.

• Chiron Corp., of Emeryville, Calif., initiated a new Phase II study of Proleukin interleukin-2 plus rituximab in rituximab-na ve patients with low-grade non-Hodgkin's lymphoma. The randomized study will employ translational medicine to determine the Fc-gamma RIIIa genotypes of patients and identify those who are more likely to respond to treatment.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., said Phase II data of ProMune combined with chemotherapy compared to the standard chemotherapy alone in advanced non-small-cell lung cancer showed objective tumor responses. About 42 percent of the 31 patients given ProMune vs. 24 percent of 17 patients given chemotherapy alone achieved objective tumor responses.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., and Inex Pharmaceuticals Inc., of Vancouver, British Columbia, said Phase II data indicate Onco TCS (vincristine sulfate liposomes injection) has potential to be used in combination with other cancer drugs for the first-line treatment of patients with aggressive non-Hodgkin's lymphoma. Follow-up results showed that 63 of 68 evaluable patients responded to the therapy, with 62 of them having their tumors completely eliminated for a complete response rate of 91 percent.

• Genaera Corp., of Plymouth Meeting, Pa., said Phase IIb data of squalamine in combination with carboplatin and paclitaxel in non-small-cell lung cancer showed the combination therapy was well tolerated. Overall, 72 percent of patients had stable disease or partial or complete responses, as a result of the therapy. Objective responses occurred in 24 percent of the patients.

• Genta Inc., of Berkeley Heights, N.J., said Phase III data of Genasense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma showed the product did not achieve statistical significance in the primary endpoint of survival. Patients treated with the combination therapy, however, did show a significant increase in progression-free survival compared with patients treated with dacarbazine alone (74 days vs. 49 days). The company withdrew its new drug application in May, following an FDA panel's decision not to recommend approval. (See BioWorld Today, May 4, 2004; May 14, 2004; and May 17, 2004.)

• GenVec Inc., of Gaithersburg, Md., said TNFerade in unresectable, locally advanced pancreatic cancer showed a median survival of 200 days at 6.6 months and 235 days at 7.8 months. TNFerade was used in combination with standard chemotherapy and radiation as front-line therapy. More than half of the patients treated at the highest dose level remained alive at 340 days.

• GTx Inc., of Memphis, Tenn., said Acapodene had positive Phase II data in treating side effects associated with androgen deprivation therapy. Acapodene was well tolerated at all doses studied, resulting in an increase in bone mineral density after six months of therapy, compared to a decrease in the placebo group.

• Immunomedics Inc., of Morris Plains, N.J., said a pilot study of epratuzumab in combination with rituximab and CHOP chemotherapy showed an objective response rate of 87 percent, with 67 percent of the patients having a complete response. There was a high incidence of Grade 4 neutropenia with the therapy.

• Medarex Inc., of Princeton, N.J., said in a Phase II study overall response rate in metastatic melanoma patients treated with MDX-010 and dacarbazine was 17.1 percent, or six of 35 patients, with a median duration of complete/partial responses ongoing at 167 days. One patient experienced ongoing complete response at 10 months and five patients had partial responses, with the longest duration also 10 months.

• MedImmune Inc., of Gaithersburg, Md., said a Phase III trial involving 303 head and neck cancer patients showed that Ethyol (amifostine) reduced the incidence of moderate to severe dry mouth (xerostomia) in patients receiving radiation therapy. Data also showed that two years after treatment, patients treated with Eythol retained the ability to produce saliva, and that there was no evidence of tumor progression for the 24-month period of the study.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said Phase III data showed a statistically significant improvement in survival in patients treated in the Velcade-only arm compared to those treated with high-dose dexamethasone. Researchers saw about a 30 percent reduction in the risk of death during the first year in patients with relapsed multiple myeloma receiving Velcade. Velcade improved time to disease progression, the primary endpoint, by 58 percent, compared to patients receiving dexamethasone. In a non-small-cell lung cancer Phase II trial, Velcade showed promising activity both as a single agent and in combination with Taxotere.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said Phase II data of BAY 43-9006 used as a single agent in patients with advanced renal-cell carcinoma resulted in a high level of durable disease stabilization or tumor shrinkage. Thirteen of 37 patients experiencing tumor shrinkage had their tumors shrink by at least 50 percent at the 12-week assessment. The trial had 89 participants.

• Procyon Biopharma Inc., of Montreal, said Phase IIa data of PCK3145, a peptide being studies for metastatic hormone-refractory prostate cancer, confirmed the safety, tolerability and preliminary efficacy of the drug at all dose levels tested. Most adverse events were not clinically significant and unrelated to the study medication.

• Seattle Genetics Inc., of Bothell, Wash., said SGN-15 used in combination with Taxotere to treat non-small-cell lung cancer was well tolerated, resulting in improved overall survival compared to Taxotere alone.

• Sonus Pharmaceutical Inc., of Bothell, Wash., said Phase IIa data of Tocosol paclitaxel show encouraging efficacy in patients with late-stage non-small-cell lung, bladder and ovarian cancers after failure of prior chemotherapy. The data also indicate that the therapy was well tolerated.

• Telik Inc., of Palo Alto, Calif., said Phase II data of Telcyta and liposomal doxorubicin demonstrated a 46 percent objective response rate and a 77 percent disease control rate in patients with platinum-refractory or -resistant ovarian cancer. In a Phase II trial of Telcyta and docetaxel in patients with platinum-resistant non-small-cell lung cancer, the combination demonstrated a 27 percent objective response rate with one complete response and seven partial responses. The overall disease control rate was 67 percent. Telik also said a Phase II trial of Telcyta and carboplatin demonstrated a 56 percent objective response rate in patients with platinum-refractory or -resistant ovarian cancer, including three patients with complete responses. The overall disease control rate was 88 percent.

• Threshold Pharmaceuticals Inc., of South San Francisco, said data from a Phase II glufosfamide trial in breast cancer demonstrated antitumor activity when administered as second-line chemotherapy to patients who previously had received doxorubicin and cyclophosphamide. Hematological toxicity was mild, and the most common adverse effects were nausea and vomiting. In colon cancer, glufosfamide showed antitumor activity when administered as a first-line chemotherapy.

• Vical Inc., of San Diego, said Phase II data of high-dose Allovectin-7 in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma showed an overall response rate of 10.2 percent, with two complete responders and 11 partial responders. The raw median duration of response was at least 8.7 months. Allovectin-7 was safe and well tolerated.

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