Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from a phase 1 dose-escalation trial of XL147, a novel small molecule inhibitor of phosphoinositide-3 kinase (PI3K), which is implicated in tumor cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The trial is enrolling patients with metastatic or unresectable solid tumors for which known effective measures do not exist or are no longer effective. The trial is being conducted at Vall D’Hebron University Hospital, Barcelona, Spain; Mary Crowley Medical Research Center, Dallas, Texas, USA; and Dana-Farber Cancer Institute, Boston, Massachusetts, USA. Emiliano Calvo, MD, PhD, a lead investigator in the trial while Assistant Professor and Co-Director of the Phase I Unit at Vall D’Hebron University Hospital, and currently Director of Clinical Research, START-Madrid Phase I Unit at Centro Integral Oncologico Clara Campal, presented the data in a poster session (Abstract #218) at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, which is being held October 21-24 in Geneva, Switzerland. The poster will be available today on the Exelixis web site.

“We have observed robust pharmacodynamic activity in this trial, clearly demonstrating that XL147 inhibits PI3K in patients at well-tolerated doses,” said Michael M. Morrissey, PhD, President of Research and Development at Exelixis. “We are particularly pleased to see the preliminary signs of clinical benefit in some patients who have received XL147. We are very encouraged by these data, and believe they support the development of this compound both as a single agent and in combination with other anti-cancer agents. Our work with XL147 is one of several approaches we are taking toward PI3K pathway inhibition. We are also developing XL765, which targets PI3K and mTOR, a downstream effector in the pathway. We believe that pursuing multiple approaches to targeting this important signaling pathway is warranted given the diverse genotypes and cancers that involve activation of this pathway.”

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Aurora inhibitors play a key role in cell duplication and are implicated in both the onset and progression of numerous types of tumour. A lecture focusing on Aurora kinase inhibitors will be presented today by Dr. Bernard Laffranchi during the 20th EORTC-NCI-AACR Symposium “Molecular Targets and Cancer Therapeutics” organised from 21st to 24th October 2008 in Geneva. Dr Laffranchi, Director Clinical Research of Nerviano Medical Sciences, the largest R&D cancer drug stand alone company in Europe (http://www.nervianoms.com) has been invited to give a presentation on the state-of-the-art of Aurora kinase inhibitors, providing a comprehensive summary of ongoing clinical studies being performed on this molecular target to which increasing attention is being paid by the experts.

“Nerviano Medical Sciences (NMS) has been chosen by these prestigious scientific societies in view of the fact that the Italian centre has a recognized leadership in research & development of Aurora inhibitors,” explains Francesco Colotta, Research & Development Director at NMS. Indeed, compounds capable of inhibiting activity of this kinase family and displaying anti-tumour efficacy in a wide range of solid and blood cancers models were first identified at Nerviano. Moreover, emphasises Dr. Colotta, the Aurora inhibitors discovered at Nerviano were the first to be evaluated in patients and to undergo clinical development.

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Proteolix, Inc., a leader in the discovery and development of novel therapeutics that target protein degradation pathways in cancer and autoimmune diseases, presented positive data from a Phase 1 clinical trial of carfilzomib (PR-171) in patients with advanced solid tumors at the 20th EORTC-NCI-AACR symposium on “Molecular Targets and Cancer Therapeutics” in Geneva, Switzerland.

The Phase 1 clinical trial was designed to assess the safety, pharmacokinetics and pharmacodynamics of carfilzomib among patients with advanced solid tumors who had previously failed at least two rounds of prior treatment with approved chemotherapies. Patients received carfilzomib administered for two consecutive days for each of the first three weeks on a four week cycle. Dosing commenced at 20 mg/m2 and escalated thereafter to a dose of 36 mg/m2.

A total of fourteen patients were enrolled in the study. Of those, one renal cell (clear cell) patient who had previously failed three prior rounds of treatment achieved a partial response and remains on the study after eight months of treatment. One small cell lung cancer patient achieved stable disease and is continuing on study after six months, and a mesothelioma patient achieved stable disease for five months.

“Carfilzomib is a highly specific inhibitor of the proteasome and the results observed in this Phase 1 clinical trial are very encouraging,” said Kyri Papadopoulos, M.D., principal investigator on the study from South Texas Accelerated Research Therapeutics (START). “Novel agents that positively impact patient outcomes without adding significant toxicities are desperately needed to complement and improve existing cancer treatment regimens. I look forward to the results from further clinical evaluation of the activity of carfilzomib in a variety of tumor types.”

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Nektar Therapeutics (Nasdaq: NKTR) announced that positive preclinical data for NKTR-105 (PEG-docetaxel) was presented at the 2008 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) Symposium on Molecular Targets and Cancer Therapeutics being held in Geneva, Switzerland. NKTR-105 is the second oncology development program derived from Nektar’s innovative small molecule PEGylation technology platform.

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Moffitt Cancer Center will host the second biennial Latinos y el cancer Educational Symposium November 8 from 9:30 a.m. to 2 p.m. in the Vincent A. Stabile Research Building, 12902 Magnolia Drive The event is free and open to the public and will be conducted entirely in Spanish.

This educational symposium is designed to provide cancer education and resources to the Tampa Bay Hispanic community. The symposium will include short presentations on several types of cancer and other topics related to the disease. Attendees will have the opportunity to register in the National Marrow Donor Program (NMDP) to become potential bone marrow donors.

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In 2007, according to the National Cancer Institute, an estimated 67,100 new cases of bladder cancer will be diagnosed in the United States and 13,750 people will die of the disease. For most men suffering from invasive bladder cancer, the most serious kind, treatment typically involves open surgery to remove the bladder as well as the nearby prostate and reconstruction of an ileum conduit or neobladder to divert urine. In 20-30 percent of cases of bladder cancer involving men, an incidental finding of prostate cancer will also be discovered.

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Analysis of data from several phase I and II clinical trials of a new cancer vaccine has shown it is capable of eliciting an immune response in most patients with bowel, kidney and prostate cancer, and that it may provide clinical benefit.

In a news briefing at the 20th EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics in Geneva yesterday (Thursday 23 October), Dr Richard Harrop, vice-president of clinical immunology at Oxford BioMedica, a UK-based biotechnology company - said: “Our exploratory analyses of data from nine different trials of TroVax® demonstrate significant associations between immune responses and overall survival in patients with colorectal cancer, renal cancer and prostate cancer.

“While it is essential that these observations are confirmed in large, randomised studies, collectively the data suggest that TroVax could provide some clinical benefit to cancer patients. In addition, the data show the vaccine is well tolerated by patients.”

TroVax is made up of a modified virus (Modified Vaccinia Ankara (MVA)), which acts as a vehicle to transport a second component, a gene that produces an antigen that is present in most solid tumours, called 5T4. TroVax is injected into patients whose solid tumours have the 5T4 tumour antigen present, so that the vaccine can trigger the body’s natural immune responses to mobilise against 5T4.

“The virus acts as both a ‘vehicle’ to deliver the 5T4 antigen and as an ‘adjuvant’, which helps to ensure we stimulate a strong immune response to the 5T4 antigen,” explained Dr Harrop. “Antibody and cellular responses can occur in response to both the viral vector (MVA) and to the 5T4 antigen.”

The analysis, presented at the symposium in Geneva, looked at data from 189 patients who had taken part in nine trials of TroVax in the UK and USA. The patients received an average of five injections (with a range of 1-12), and it was well tolerated by patients when given either on its own or in combination with other anti-cancer treatments. Of 180 patients tested for antibody responses after vaccination, 88% (159) showed positive responses to 5T4 and 98% (176) showed positive responses to MVA.

The highest levels of antibody responses were detected after an average of two vaccinations for the MVA part of the vaccine and after four for 5T4. Dr Harrop said: “This was expected because MVA is a foreign virus which the immune system responds to more quickly than to a ’self antigen’ such as 5T4.”

He continued: “When looking at the results from all the trials (colorectal, renal and prostate cancer patients), the magnitude of the 5T4-specific antibody response was associated with increased patient survival. Indeed, a doubling of the average number of antibodies in the patients between the first and third injections was associated with a reduction in the relative risk of death of 17%. This effect was strongest in colorectal cancer patients.

“Both the magnitude and the frequency of immune responses elicited against our tumour target (5T4) are exceptionally high and could be considered ‘best in class’. Since cancer vaccines rely on the induction of immune responses to be able to work, this is a very important attribute of TroVax.”

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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today presented preclinical data on the investigational mTOR inhibitor, deforolimus, alone or in combination with the anti-androgen agent, bicalutamide, in models of prostate cancer. This investigational study shows that the combination inhibits the growth of prostate cancer cell lines in various model systems. The data were presented at the EORTC-NCI-AACR (ENA) symposium on “Molecular Targets and Cancer Therapeutics” held in Geneva, Switzerland this week and provide the scientific rationale for an ongoing Phase 2 clinical trial examining the same combination in patients with advanced prostate cancer.

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SuperGen, Inc. (NASDAQ: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today presented data on MP-470, its lead product candidate, and four additional posters, at the 20th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics” in Geneva, Switzerland. MP-470, an orally bio-available multi-targeted tyrosine kinase inhibitor, showed encouraging tumor regression results in the first two arms (paclitaxel/carboplatin and carboplatin/etoposide) of its current Phase 1b clinical trial examining MP-470 combined with five standard of care (SOC) anticancer treatments.

“We are extremely pleased to report a series of important clinical and scientific advances achieved by our Company,” said James S. Manuso, Ph.D., SuperGen’s President and Chief Executive Officer. “In addition to MP-470’s progress in the clinic, before year-end, we expect to enter SGI-1776, our PIM kinase inhibitor, into Phase 1 clinical trials. This will be our second novel drug in clinical development.”

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The Food and Drug Administration (FDA) has accepted the proposal made by PharmaMar, of the Zeltia Group for the production process of Aplidin®, a new marine-derived anti-tumor agent, in clinical development for the treatment of hematological and solid tumors.

The starting materials for the initiation of the production process have also been approved. Approval from the FDA confirms the strategy PharmaMar has established for the production process of Aplidin®, a process that is already fully defined.

It is an FDA requirement that companies producing drugs submit full paperwork on the synthesis of their medicines. This information on the medicines synthesis together with the approval of the regulatory agency, are included in the registration dossier of a medicine.

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