Inex Pharmaceuticals Corp. presented interim results from an ongoing non-Hodgkin's lymphoma Phase II trial at the American Society of Clinical Oncology meeting in Orlando, Fla., and the results showed all patients responded to the treatment.

Inex, of Vancouver, British Columbia, presented interim results for its lead product, Onco TCS, in combination therapy for the first-line treatment of aggressive non-Hodgkin's lymphoma. Results from 26 patients in the Phase II trial showed all patients responded to treatment. Twenty-five patients of the 26 completely responded to therapy and had all their tumors eliminated; one patient partially responded and had tumor volume decreased by more than 50 percent for an overall response rate of 100 percent.

The trial is being conducted at the University of Texas M.D. Anderson Cancer Center in Houston. The lead investigator for the trial, Alma Rodriguez, said the data were from patients who are more than 60 years of age. The trial will conclude with a total of 73 patients.

The current standard first-line treatment for aggressive NHL is the CHOP chemotherapy combination - cyclophosphamide, doxorubicin hydrochloride, Oncovin (vincristine) and prednisone. In the Phase II trial, Onco TCS replaced Oncovin. Onco TCS is vincristine encapsulated inside Inex's liposomal drug delivery technology, Transmembrane Carrier System (TCS).

Onco TCS is being evaluated in eight other clinical trials for several cancers, including a pivotal Phase II/III trial for the treatment of relapsed aggressive NHL.

In other news from the meeting:

AEterna Laboratories Inc., of Quebec City, Quebec, said a planned safety analysis of its two Phase III trials in renal-cell carcinoma with Neovastat were completed with positive results. The Data Safety Monitoring Board in each trial concluded that both studies could continue with no adjustments. Neovastat is in two Phase III trials for the treatment of lung and kidney cancer, and one Phase II trial for the treatment of multiple myeloma.

AltaRex Corp., of Waltham, Mass., said final results of its OvaRex (oregovomab) 345-patient study in Stage III/IV ovarian cancer patients established that patients with optimal surgical debulking and sensitivity to platinum chemotherapy are most likely to achieve clinical benefit from OvaRex treatment in the adjuvant setting following front-line treatment. The company said the presentation, along with presentations it has made in the past, establish a foundation with which to advance OvaRex development.

Antigenics Inc., of New York, presented interim results of five clinical trials, including three evaluating Oncophage in the treatment of melanoma, gastric and colorectal cancers. The Phase I and II studies showed that patients treated with Oncophage experienced clinical and immunological response. Oncophage is a personalized cancer treatment derived from each individual patient's tumor.

AVI BioPharma Inc., of Portland, Ore., presented complete survival data from a Phase II trial of Avicine cancer vaccine. Pancreatic cancer patients were treated with Avicine alone or in combination with gemcitabine. The group treated with both Avicine and gemcitabine had a significantly improved one-year survival rate of 30 percent. AVI plans to initiate Phase III studies in pancreatic cancer in late 2002 with its U.S. marketing and co-development partner, SuperGen Inc., of Dublin, Calif.

BioNumerik Pharmaceuticals Inc., of San Antonio, and Grelan Pharmaceutical Co. Ltd., of Tokyo, presented results from a Phase I study of BNP7787 in patients with advanced non-small-cell lung cancer receiving paclitaxel and cisplatin. No severe nerve damage was seen in any of the patients. Nine of the 21 patients experienced a partial tumor remission after two cycles of treatment with BNP7787 and paclitaxel and cisplatin. Eight patients experienced no progression. BNP7787 is a chemoprotecting agent.

Bio-Technology General Corp., of Iselin, N.J., reported preliminary data on oxandrolone, an oral synthetic derivative of testosterone, in a study of cancer-related weight loss. Analysis of results of a subgroup of patients with complete data by weight category showed 81 percent of patients gained or maintained weight during the first two months, among other things. Oxandrolone use in cancer patients actively losing weight at study entry was associated with increased weight, increased body cell mass and improved performance status and quality of life scores, the company said.

EntreMed Inc., of Rockville, Md., reported data, including a complete tumor response, partial tumor responses and stable disease, from its Phase I trial that combined Panzem and Taxotere to treat patients with metastatic breast cancer. Findings presented demonstrated that the Panzem-Taxotere treatment was well tolerated with mild side effects. Separately, the company released Phase I data showing that Panzem was well tolerated and it stabilized disease for periods in patients with refractory metastatic breast cancer. Panzem provided clinical benefit in several patients and clinical investigators reported that Panzem did not alter patient hormone levels.

Genentech Inc., of South San Francisco, is the developer of Herceptin, which was used in a study conducted by the Sarah Cannon Cancer Center that also included Taxol (paclitaxel) plus Paraplatin (carboplatin). In the trial, in which 58 patients were evaluable, results showed that in advanced breast cancer patients, the addition of weekly Taxol and Paraplatin to Herceptin produced improved responses as compared to Herceptin alone, investigators said.

ImmunoGen Inc., of Cambridge, Mass., presented data from Phase I studies conducted with cantuzumab mertansine. The studies showed the product was well tolerated. No data related to biologic activity in the ongoing study were presented, but indications of antitumor activity previously reported include reductions in the carcinoembryonic antigen tumor marker and evidence of disease regression in several pretreated patients, the company said. Cantuzumab mertansine is a tumor-activated prodrug created by conjugating the cytotoxic agent DM1 with the humanized monoclonal antibody C242.

Immunomedics Inc., of Morris Plains, N.J., said investigators summarized results from a trial using radioimmunotherapy in 25 patients with metastatic tumors expressing carcinoembryonic antigen (CEA). In a Phase I/II study, patients received a bispecific antibody having one arm composed of Immunomedics' humanized anti-CEA antibody. Of 23 assessable patients, the average tumor-absorbed doses of the I-131 radiation was more than double with the bispecific antibody method than the directly labeled antibody. The company also presented results of its antibody in preclinical studies.

Kosan Biosciences Inc., of Hayward, Calif., reported interim results from its trial of KOS-862 (Epothilone D). The company has two ongoing Phase I trials with a third expected to be initiated this year. Results showed KOS-862 is well tolerated without dose-limiting toxicities or myelosuppression. Kosan said dose escalation is continuing as planned and the program remains on schedule for the initiation of Phase II testing late this year or early in 2003.

Ligand Pharmaceuticals Inc., of San Diego, reported a preliminary analysis of Phase I/II data showing that adding Targretin (bexarotene) capsules to standard chemotherapy may enhance the activity of lung cancer treatment and reduce the growth rate of lung cancer without causing unexpected side effects. In a separate presentation, eight of nine patients with fludarabine-refractory chronic lymphocytic leukemia (CLL) who were treated with at least three courses of Ligand's Ontak (denileukin diftitox) had reductions in peripheral CLL cells, with two patients achieving reductions of 99 percent or more. Three of the patients had a greater than 50 percent reduction in the diameter of their cancerous lymph nodes. One patient has had no evidence of adenopathy in follow-up exams and scans, and has ongoing partial remission after more than two months of treatment.

MediGene AG, of Martinsried, Germany, said investigators reported preliminary clinical results of its oncolytic herpes simplex virus product, NV1020, from a Phase I trial that delivers the product into the bloodstream for the treatment of liver metastases derived from colorectal cancer. Results from 10 patients at four dose levels demonstrated that NV1020 can be administered via the bloodstream. Tumors were radiographically stable and all subjects experienced a decrease in the tumor marker CEA during the 28-day period. The study is ongoing with final results expected in the third quarter.

Merck KGaA, of Darmstadt, Germany, presented data on its pipeline of drugs, including cetuximab (Erbitux). Investigators presented data on cetuximab in combination with cisplatin or carboplatin in 75 patients with recurrent/metastatic squamous-cell carcinoma of the head and neck who were failing treatment with cisplatin or carboplatin. The addition of cetuximab to the previously ineffective chemotherapies resulted in an overall response rate of 10.7 percent. Another 36 percent of patients showed stabilization of disease for more than six weeks. The overall rate of disease control was 46.7 percent. Cetuximab is licensed from ImClone Systems Inc., of New York, for regions outside North America.

Millennium Pharmaceuticals Inc., of Cambridge, Mass., said MLN341 (formerly LDP-341 and PS-341) was well tolerated and showed signs of antitumor activity when combined with the standard chemotherapy agents Gemzar (gemcitabine) and Camptosar (irinotecan) in certain pancreatic, lung and colorectal cancers. The studies were from two ongoing Phase I trials. MLN341 is designed to specifically inhibit proteasomes.

Peregrine Pharmaceuticals Inc., of Tustin, Calif., reported research demonstrating in preclinical studies its Vasopermeation Enhancement Agent (VEA) technology can improve the efficacy of some chemotherapeutic drugs for the treatment of various solid tumors. Pretreatment with VEAs in tumor-bearing mice resulted in a 150 percent to 300 percent enhancement of chemotherapeutic uptake in tumors with no concomitant increase seen in normal tissues. VEAs are a new class of drugs designed to increase the uptake of cancer therapeutics and imaging agents at the tumor site.

Procyon Biopharma Inc., of Montreal, said its monoclonal antibody, 2C5, Antinucleosome Antibody, showed reduction of tumor growth in xenograft models of human small-cell lung cancer in nude mice. Previous studies showed similar activity of the monoclonal against murine melanoma, lymphoma and colon cancer. 2C5 binds to nucleosomes released by dying cancer cells and concentrates preferentially at the surface of other cells.

QLT Inc., of Vancouver, British Columbia, said data on its late-stage cancer compound, tariquidar, were presented, showing it to be an effective inhibitor of P-gp, a membrane protein that pumps chemotherapy out of cells. Tariquidar is in a Phase II breast cancer trial and QLT plans to initiate a Phase III non-small-cell lung cancer program shortly. Following Phase III work, QLT said it plans to file for approval in the U.S. in advanced non-small-cell lung cancer in combination with first-line chemotherapy in 2005.

Seattle Genetics Inc., of Bothell, Wash., presented data on its SGN-15 Phase II breast and colon studies, as well as its SGN-10 Phase I single-agent study and had an abstract presented related to its ongoing Phase II study of SGN-15 in patients with prostate cancer. The company completed its first study in colon cancer and accrued more than half of the targeted patients in the breast cancer study. The company is expanding the number of clinical sites in its prostate and lung cancer trials and expects to open a study in ovarian carcinoma later in 2002. It said it made a key finding with SGN-10, discovering that by using Rituxan, it can achieve a longer administration of SGN-10 in patients with solid tumors.

Sonus Pharmaceuticals Inc., of Seattle, said investigators reported antitumor activity in the Phase I study with Sonus' lead cancer product, Tocosol Paclitaxel. In the study, tumor responses have been demonstrated in 14 out of 34 (41 percent) evaluable patients. Three of those have partial responses, two have minor responses and nine have transitioned into stable disease. The company also said enrollment in its Phase I study is complete at 37 patients.

SuperGen Inc., of Dublin, Calif., reported data from a Phase II trial suggesting Orathecin is effective against chordoma, a type of bone tumor. Of the nine patients in the study, four have confirmed metastatic disease. The results showed one near-complete response of 251 days, but was limited by the patient deciding to discontinue therapy. Three patients demonstrated stability of disease ranging from 165 to 317 days. Freedom from progression at three and six months was 66 percent and 33 percent, respectively.