Thursday, May 31, 2012
multiple myeloom
Interim
results from a Phase I/II clinical study suggesting that a single
vaccine can treat myeloma and other cancers has generated a deluge of
interest in the popular press recently.
Last week, several newspapers published articles about a therapeutic vaccine that has the potential to train the body’s immune system to seek out and destroy myeloma cells. These stories were based on a press release issued by the Israeli biotechnology company, Vaxil Biotherapeutics.
The vaccine, known as ImMucin, targets a protein called MUC-1 found in abundance on the surface of 90% of cancer cells including myeloma cells. When the vaccine is injected into the patient’s body, it stimulates an immune response which identifies and removes cancer cells which express MUC-1.
ImMucin is currently being investigated in a Phase I/II study in myeloma patients in Israel. Of the ten patients recruited to date, seven have successfully completed treatment. Although the results have not yet been published in a recognised peer-reviewed medical journal, the press release stated that ImMucin generated a robust and specific immune response after 2 - 4 doses out of a maximum of 12 doses in all patients with no side-effects.
Importantly, the vaccine showed signs of clinical efficacy, with some patients demonstrating a reduction in their myeloma one month after completing treatment; three patients showed a complete response (no detectable paraprotein).
While ImMucin appears to be safe and the initial results in myeloma patients promising, it remains too preliminary to conclude that the vaccine is an effective treatment for myeloma or any other cancer.
More work with a much larger number of patients will need to be carried out and followed-up for a longer period of time to prove that ImMucin is safe and effective in myeloma patients.
About MUC-1:
MUC-1 belongs to a family of sugar-coated proteins called mucins found in normal cells such as those lining the surface of organs including the lung, stomach, intestines and eyes. Mucins protect the body from infection by preventing pathogens such as bacteria and viruses from reaching the cell surface.
Excessive amounts of MUC-1 are associated with different types of cancer. However, in cancer cells, the sugar make up of MUC-1 is different to that on normal cells. This means that MUC-1 on cancer cells can be targeted without affecting normal cells.
About vaccines:
A vaccine is a biological preparation which improves the immune system’s natural ability to protect the body against disease caused by “foreign agents”. Originally, vaccines were developed to protect the body against infectious microbes. The vaccine itself is made up of a harmless version of the microbe that does not cause disease but stimulates an immune response against the microbe. More recently, cancer vaccines have been developed to prevent or treat existing cancers; usually a protein that is unique to the cancer is used as the target for the immune system to act on.
ImMucin is one of many MUC-1 based cancer vaccines currently being tested in myeloma and other cancers in over 30 clinical studies worldwide.
About the ImMucin study:
The ImMucin study is being conducted by Vaxil Biotherapeutics at the Hadassah Medical Center, Jerusalem, Israel. A Phase I/II study is currently ongoing, with a total of 15 myeloma patients expected to enrol. There is no information as yet if the study will open elsewhere in the world.
ImMucin - a potential vaccine for myeloma?
25-04-2012
Interim
results from a Phase I/II clinical study suggesting that a single
vaccine can treat myeloma and other cancers has generated a deluge of
interest in the popular press recently.Last week, several newspapers published articles about a therapeutic vaccine that has the potential to train the body’s immune system to seek out and destroy myeloma cells. These stories were based on a press release issued by the Israeli biotechnology company, Vaxil Biotherapeutics.
The vaccine, known as ImMucin, targets a protein called MUC-1 found in abundance on the surface of 90% of cancer cells including myeloma cells. When the vaccine is injected into the patient’s body, it stimulates an immune response which identifies and removes cancer cells which express MUC-1.
ImMucin is currently being investigated in a Phase I/II study in myeloma patients in Israel. Of the ten patients recruited to date, seven have successfully completed treatment. Although the results have not yet been published in a recognised peer-reviewed medical journal, the press release stated that ImMucin generated a robust and specific immune response after 2 - 4 doses out of a maximum of 12 doses in all patients with no side-effects.
Importantly, the vaccine showed signs of clinical efficacy, with some patients demonstrating a reduction in their myeloma one month after completing treatment; three patients showed a complete response (no detectable paraprotein).
While ImMucin appears to be safe and the initial results in myeloma patients promising, it remains too preliminary to conclude that the vaccine is an effective treatment for myeloma or any other cancer.
More work with a much larger number of patients will need to be carried out and followed-up for a longer period of time to prove that ImMucin is safe and effective in myeloma patients.
About MUC-1:
MUC-1 belongs to a family of sugar-coated proteins called mucins found in normal cells such as those lining the surface of organs including the lung, stomach, intestines and eyes. Mucins protect the body from infection by preventing pathogens such as bacteria and viruses from reaching the cell surface.
Excessive amounts of MUC-1 are associated with different types of cancer. However, in cancer cells, the sugar make up of MUC-1 is different to that on normal cells. This means that MUC-1 on cancer cells can be targeted without affecting normal cells.
About vaccines:
A vaccine is a biological preparation which improves the immune system’s natural ability to protect the body against disease caused by “foreign agents”. Originally, vaccines were developed to protect the body against infectious microbes. The vaccine itself is made up of a harmless version of the microbe that does not cause disease but stimulates an immune response against the microbe. More recently, cancer vaccines have been developed to prevent or treat existing cancers; usually a protein that is unique to the cancer is used as the target for the immune system to act on.
ImMucin is one of many MUC-1 based cancer vaccines currently being tested in myeloma and other cancers in over 30 clinical studies worldwide.
About the ImMucin study:
The ImMucin study is being conducted by Vaxil Biotherapeutics at the Hadassah Medical Center, Jerusalem, Israel. A Phase I/II study is currently ongoing, with a total of 15 myeloma patients expected to enrol. There is no information as yet if the study will open elsewhere in the world.
- For more information on ImMucin contact Maggie.Lai@myeloma.org.uk or call the Infoline: 0800 980 3332
- Search our Clinical Trial Tracker for clinical studies currently open for recruitment in the UK: http://www.myeloma.org.uk/patient-information/clinical-trials/patient-trial-tracker/
Wednesday, May 30, 2012
From Journal Watch > Journal Watch (General)
Aspirin to Prevent Cancer
The Story Continues to Evolve
Posted: 05/21/2012; Journal Watch © 2012 Massachusetts Medical Society
- Abstract and Introduction
- Comment
Abstract and Introduction
Abstract
Daily aspirin reduced short-term risk for cancer incidence and death, and also lowered risk for metastasis.Introduction
Previous meta-analyses of long-term follow-up data from five large randomized trials of daily aspirin for prevention of vascular events showed that, compared with placebo or no treatment, aspirin lowered colon cancer incidence and mortality after 8 to 10 years and lowered mortality from other common solid cancers after 5 to 15 years (JW Gen Med Dec 29 2011). Now, these investigators have conducted two new meta-analyses of trials of aspirin for preventing vascular events: One, designed to assess the short-term effects of aspirin on cancer incidence and mortality, included in-trial data from 51 studies that involved more than 77,000 patients — and the other, aimed at studying aspirin's effects on risk for metastasis, included data from five U.K. studies that involved more than 17,000 patients.In the first analysis, 34 trials in which cancer deaths were reported showed that significantly fewer such deaths occurred among patients who received aspirin (odds ratio, 0.85); this benefit was most pronounced ≥5 years after randomization (OR, 0.63). In six primary-prevention trials, cancer incidence was significantly lower for patients who received aspirin (OR, 0.88), and this benefit was apparent after 3 years of follow-up. Meanwhile, aspirin's prevention of vascular events and its association with extracranial bleeds both waned, becoming nonsignificant after 3 years.
Aspirin's observed benefits after 3 to 5 years of follow-up suggest that it might inhibit metastasis, not just initial carcinogenesis. In the second meta-analysis, the investigators assessed time to diagnosis of solid cancers and identification of metastases. Aspirin slightly lowered the overall incidence of cancer; moreover, compared with cancers in the control group, more cancers in the aspirin group remained localized (OR, 1.24), whereas fewer cancers metastasized (OR, 0.64). Among patients who developed incident solid cancers, those taking aspirin were significantly less likely to have metastases at diagnosis or follow-up (OR, 0.59). This effect was significant only for colorectal cancers (OR, 0.36) and all adenocarcinomas (OR, 0.52). Among patients with initial diagnoses of localized cancer, those taking aspirin had significantly lower risk for subsequent metastasis (hazard ratio, 0.45) and better survival rates (HRs, 0.71 for cancer-related deaths and 0.81 for all-cause deaths).
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From Therapeutic Advances in Drug Safety
Safety of Statins
An Update
Posted: 05/22/2012; Ther Adv in Drug Safe. 2012;3(3):133-144. © 2012 Sage Publications, Inc.
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- Abstract and Introduction
- Muscle Toxicity
- Liver Enzyme Abnormalities
- Risk of Incident Diabetes
- Haemorrhagic Stroke
- Summary
Abstract and Introduction
Abstract
Statins are widely used and have been proven to be effective in the prevention of atherosclerotic vascular disease events, primarily by reducing plasma low-density lipoprotein cholesterol concentrations. Although statins are generally well tolerated and present an excellent safety profile, adverse effects from muscle toxicity and liver enzyme abnormalities may occur in some patients. Myopathy and rhabdomyolysis are rare with statin monotherapy at the approved dose ranges, but the risk increases with use of higher doses, interacting drugs and genetic predisposition. Asymptomatic increases in liver transaminases with statin treatment do not seem to be associated with an increased risk of liver disease. Therefore, statin treatment can be safely used in patients with mild to moderately abnormal liver tests that are potentially attributable to nonalcoholic fatty liver disease and can improve liver tests and reduce cardiovascular morbidity in this group of patients. The risks of other unfavorable effects such as the slightly increased risk of new-onset diabetes and potentially increased risk of haemorrhagic stroke are much smaller than the cardiovascular benefits with the use of statins.Friday, May 25, 2012
Aspirin Prevents Recurrent Unprovoked Venous Thromboembolism
Aspirin is probably less effective –– but safer –– than warfarin.Patients with unprovoked venous thromboembolism (VTE) face a dilemma: Recurrent VTE is common after warfarin anticoagulation is stopped, but the cumulative incidence of serious bleeding is high when patients continue warfarin therapy indefinitely. This difficult tradeoff provides an impetus to see whether aspirin is a suitable alternative for such patients.
Italian researchers identified 403 patients with a first symptomatic VTE event that was unprovoked (i.e., not associated with standard VTE risk factors); 63% had proximal deep venous thrombosis, and 37% had pulmonary embolism. After 6 to 18 months of treatment with a vitamin K antagonist, patients were randomized to either aspirin (100 mg daily) or placebo for 2 years.
The incidence of recurrent VTE was significantly lower in the aspirin group than in the placebo group (6.6% vs. 11.2% annually; P=0.02). The frequency of bleeding events was identical in the two groups (1 major bleed and 3 nonmajor bleeds). Aspirin afforded protection both to patients whose index event was deep venous thrombosis and to those whose index event was pulmonary embolism.
Comment: For patients with unprovoked VTE, this trial provides persuasive evidence that aspirin reduces the incidence of recurrent events after conventional warfarin therapy. Aspirin is less effective than warfarin, but bleeding risks are lower with aspirin. Newer oral anticoagulants (e.g., dabigatran and rivaroxaban) have also been studied as extended maintenance therapies for patients with VTE, but are not yet FDA-approved for this purpose.
— Allan S. Brett, MD
Published in Journal Watch General Medicine May 24, 2012
