CancerVax Corp. said a retrospective analysis of Phase II data indicated that Canvaxin increased survival in patients with Stage II melanoma, according to data reported at the American Association for Cancer Research meeting.
Researchers from the John Wayne Cancer Institute documented a matched-pair analysis of 315 patients with Stage Ib/II melanoma who received the drug following surgical removal of their tumors, compared to 315 historical control patients who did not receive Canvaxin. Findings indicated that the 25th percentile of survival for the patients treated with Canvaxin was 74.8 months, while the 25th percentile of survival for the control group was 44 months (p=0.03).
The results are similar to the survival benefit found in previous retrospective studies in Stage III and Stage IV melanoma. The immunotherapy product remains in Phase III trials for Stage III and Stage IV melanoma.
The Carlsbad, Calif.-based company also reported preclinical findings demonstrating that humanized monoclonal antibodies and a synthetic peptide licensed to its wholly owned subsidiary, Cell-Matrix Inc., suppress angiogenesis and inhibit tumor growth in animal models of melanoma and breast cancer.
The 95th AACR conference, which began Saturday in Orlando, Fla., ended Wednesday.
In other news from the meeting:
• AEterna Laboratories Inc., of Quebec City, Quebec, said its Zentaris GmbH subsidiary reported positive preclinical results showing nontoxic concentrations of ZEN-014 inhibited endothelial cell sprouting and vessel formation. Also, cancer cells (KB/HeLa) were arrested completely in the G2M phase of mitosis at nanomolar concentrations and subsequently underwent apoptosis.
• Cylene Pharmaceuticals Inc., of San Diego, reported preclinical data showing that CX-3543 reduced expression of the c-Myc oncogene and inhibited tumor growth in colorectal tumor animal models. The small molecule also inhibited growth of prostate and pancreatic tumor models in mice. Cylene said it selected CX-3543 as the first of its oncogene inhibitors that it will advance toward clinical trials.
• EntreMed Inc., of Rockville, Md., reported preclinical findings showing that three lead oncology analogues have a reduced rate of metabolism and improved pharmacokinetics and antitumor activity in animal models. They exhibited the ability to induce apoptosis, target microtubules and inhibit hypoxia inducible factor 1, which is overexpressed in more than 70 percent of human cancers and their metastases.
• Human Genome Sciences Inc., of Rockville, Md., and DakoCytomation A/S, of Glostrup, Denmark, said new assays distinguish between expression of the TRAIL Receptor-1 and TRAIL Receptor-2 proteins, and are suitable for further exploration of the relationship between TRAIL-R1 and TRAIL-R2 expression and therapeutic response to agonistic antibodies. The companies entered an agreement under which DakoCytomation acquired exclusive worldwide rights to develop and commercialize pharmacogenomic diagnostic tests in the field of oncology based on TRAIL-R1 and TRAIL-R2. DakoCytomation will be the exclusive partner of HGS for any licensed immunohistochemical diagnostic products based on the TRAIL-R1 or TRAIL-R2 proteins.
• Hybridon Inc., of Cambridge, Mass., said a Phase I trial showed HYB2055 was safe and biologically active in healthy volunteer subjects. The company said it expects to begin a Phase II study of the drug, named IMOxine in oncology applications, in cancer patients later this year. HYB2055 is a second-generation immunomodulatory oligonucleotide that combines a DNA structure referred to as an Immunomer and a synthetic CpR immunomodulatory motif. It is called Amplivax for vaccine adjuvant use.
• Introgen Therapeutics Inc., of Houston, reported preclinical data supporting the use of MDA-7/IL-24, the active ingredient in INGN 241, demonstrating the antitumor activity of INGN 241 in multiple cancer settings as a single agent and in combination with other therapeutic approaches. The findings show that INGN 241 can be combined with standard treatments such as radiation, and with other therapeutic agents such as monoclonal antibodies or small-molecule drugs, to enhance tumor cell death. Specifically, preclinical data demonstrate that INGN 241 enhances the antitumor effects of Herceptin (trastuzumab) in HER2-positive breast cancer.
• Kosan Biosciences Inc., of Hayward, Calif., said in vivo and in vitro data on the cytotoxic and antiproliferative effects of combining its lead epothilone, KOS-862 (Epothilone D), with carboplatin or capecitabine support clinical investigation of the combination. In a xenograft mouse model of human non-small-cell lung cancer, a combination with carboplatin demonstrated additive or synergistic effects under conditions in which weight loss of the animals was well tolerated and reversible. Other data illustrated that combinations with 5-DFUR and 5-FU resulted in broad additive or synergistic antiproliferative activity in four human breast cancer cell lines.
• Large Scale Biology Corp., of Vacaville, Calif., reported progress in its effort to develop vaccines to control papillomavirus-associated diseases. The company said its plant-based vaccine platform showed promise as a potential source of low-cost antiviral vaccinations against human papillomaviruses that cause benign and malignant tumors.
• Marshall Edwards Inc., of Washington, said various data confirm that phenoxodiol is on track in its development as a first-line therapy for early stage cancers and as a chemosensitizing agent for late-stage cancers. Findings from a Phase Ib/IIa trial in late-stage prostate cancer patients showed that oral phenoxodiol is biologically active as evidenced by a dose-dependent effect on serum prostate-specific antigen levels. Data from a Phase II study of monotherapy phenoxodiol in 40 patients with late-stage, unresponsive, recurrent ovarian cancer showed that a quarter of them responded when assessed after six weeks of treatment, although tumor mass was not assessed at the time.
• NeoPharm Inc., of Lake Forest, Ill., said data on the systemic delivery of siRNA using its recently developed NeoPhectin-AT revealed evidence of increased inhibition of tumor growth in mice. The findings describe in vivo comparability studies using NeoPhectin-AT in which enhanced transfection and lower toxicity was obtained compared to an already-marketed in vivo transfection reagent.
• OSI Pharmaceuticals Inc., of Melville, N.Y., said preclinical results showed that Tarceva, when used in combination with radiation, contributes to an increase in radiosensitization. Other results showed that in five of six bladder cancer cell lines, the drug enhanced radio-responsiveness. Additional data showed that pancreatic tumor cell lines responded to Tarceva by demonstrating growth inhibition, and that the drug might demonstrate broad-based antitumor activity in a variety of solid-tumor types.
• Sonus Pharmaceuticals Inc., of Bothell, Wash., said it is continuing to advance applications of its Tocosol drug delivery technology to the formulation of anticancer compounds. Specifically, the company reported preclinical data on its new camptothecin derivatives, including a formulation that showed increased antitumor activity in animal tumor models, as compared to an approved camptothecin analogue.
• Sunesis Pharmaceuticals Inc., of South San Francisco, reported on the in vivo antitumor activity of its lead cancer therapy, SNS-595, in a variety of mouse tumor models. The naphthyridine compound showed a dose-dependent inhibition of tumor growth with clear regressions and complete responses seen at doses at and below its maximum tolerated dose in established subcutaneous colorectal syngeneic tumors.
• Xanthus Life Sciences Inc., of Cambridge, Mass., said preclinical results showed that C-1311 demonstrated promising anticancer activity and reduced bone marrow toxicity for colon cancer treatment in comparison to several approved anticancer agents. It produced superior activity for colon cancer compared to paclitaxel, comparable activity for breast cancer and inferior activity for lung cancer. In another study, C-1311 had greater tumor killing activity in vitro in all three tested colon cancer cell lines compared to five other anticancer agents. A final study demonstrated that the drug was less toxic to both rat and human bone marrow, in vitro, than mitoxantrone.