Many people blindly use 100 nm liposomes when they target cancer tumors. Not many people know the reason behind using 100 nm liposomes.
In tumor tissue, the vasculature is discontinuous, and pore sizes vary from 100 to 780 nm. By comparison, normal vascular endothelium is around 2 nm in most tissues, 6 nm in postcapillary venules, 40–60 nm for the kidney glomerulus, and up to 150 nm for sinusoidal epithelium
of the liver and spleen. In order for the liposomes to extravasate (to pass through the walls of a vessel into the surrounding tumor tissues) they should be around 100 nm or less in order to pass through the pores.
In general, for a given liposome composition, the larger the liposome, the faster the clearance by the RES.
Wednesday, January 13, 2010
Thursday, December 17, 2009
Friday, April 24, 2009
Transave Completes Enrollment in Arikace(TM) Phase II Bronchiectasis Study
MONMOUTH JUNCTION, N.J., April 21 /PRNewswire/ -- Transave, Inc., today reported completion of patient enrollment in a Phase II study evaluating the safety and efficacy of Arikace(TM) (liposomal amikacin for inhalation) in non-cystic fibrosis (CF) bronchiectasis patients. The results, which are expected to be available by mid-year, will shed new light on how this patient population responds to treatment. Presently, there are no approved treatments for the disease.
"Today's announcement marks the achievement of yet another important milestone in the development of Arikace for chronic lung infections," said Tim Whitten, Transave's Chief Executive Officer. "We believe Arikace has the potential to be an important new treatment for non-CF patients with bronchiectasis. We look forward to seeing the Phase II results in June and moving to Phase III as soon as possible."
The double-blind, placebo-controlled study is designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections. In the trial, 64 adult patients were randomized 2:1 to Arikace - either a 280 mg or a 560 mg dose - or placebo for 28 days, followed by a 28-day off-treatment observation period. Arikace and placebo are administered once daily using an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Sixteen clinical sites throughout Europe and India are participating in the study.
Bronchiectasis is characterized by localized, irreversible enlargement of the bronchial tubes. Involved bronchi are dilated, inflamed, and easily collapsible, resulting in airflow obstruction and impaired clearance of secretions. The accumulation of mucus in the bronchi leads to frequent infections, which further reduce lung function in these patients. One of the most frequent pathogens infecting bronchiectasis patients is Pseudomonas aeruginosa, which is associated with increased sputum production, more extensive bronchiectasis, more hospitalizations, and reduced quality of life.
The disease is often misdiagnosed and mistaken for asthma or pneumonia. There is currently no drug specifically approved for the treatment of bronchiectasis or the associated lung infections in the U.S.
About Arikace (liposomal amikacin for inhalation)
Arikace is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutrally-charged liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). Arikace can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs. In addition to this clinical study in non-CF bronchiectasis patients with Pseudomonas lung infections, clinical development has been initiated in CF patients with Pseudomonas lung infections, with positive Phase II results reported in June 2008. Arikace has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF.
About PARI Pharma and the eFlow(R) Electronic Nebulizer
Arikace is delivered by an Investigational eFlow Nebulizer System developed by PARI Pharma GmbH. The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser-drilled holes. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of the hand), light weight, and efficient battery use, products incorporating eFlow Technology reduce the burden of taking daily inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.
About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company's major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave's technology and development programs, visit http://www.transaveinc.com/.
Original URL: http://sev.prnewswire.com/medical-pharmaceuticals/20090421/NY0216821042009-1.html
"Today's announcement marks the achievement of yet another important milestone in the development of Arikace for chronic lung infections," said Tim Whitten, Transave's Chief Executive Officer. "We believe Arikace has the potential to be an important new treatment for non-CF patients with bronchiectasis. We look forward to seeing the Phase II results in June and moving to Phase III as soon as possible."
The double-blind, placebo-controlled study is designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections. In the trial, 64 adult patients were randomized 2:1 to Arikace - either a 280 mg or a 560 mg dose - or placebo for 28 days, followed by a 28-day off-treatment observation period. Arikace and placebo are administered once daily using an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Sixteen clinical sites throughout Europe and India are participating in the study.
Bronchiectasis is characterized by localized, irreversible enlargement of the bronchial tubes. Involved bronchi are dilated, inflamed, and easily collapsible, resulting in airflow obstruction and impaired clearance of secretions. The accumulation of mucus in the bronchi leads to frequent infections, which further reduce lung function in these patients. One of the most frequent pathogens infecting bronchiectasis patients is Pseudomonas aeruginosa, which is associated with increased sputum production, more extensive bronchiectasis, more hospitalizations, and reduced quality of life.
The disease is often misdiagnosed and mistaken for asthma or pneumonia. There is currently no drug specifically approved for the treatment of bronchiectasis or the associated lung infections in the U.S.
About Arikace (liposomal amikacin for inhalation)
Arikace is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutrally-charged liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). Arikace can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs. In addition to this clinical study in non-CF bronchiectasis patients with Pseudomonas lung infections, clinical development has been initiated in CF patients with Pseudomonas lung infections, with positive Phase II results reported in June 2008. Arikace has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF.
About PARI Pharma and the eFlow(R) Electronic Nebulizer
Arikace is delivered by an Investigational eFlow Nebulizer System developed by PARI Pharma GmbH. The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser-drilled holes. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of the hand), light weight, and efficient battery use, products incorporating eFlow Technology reduce the burden of taking daily inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.
About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company's major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave's technology and development programs, visit http://www.transaveinc.com/.
Original URL: http://sev.prnewswire.com/medical-pharmaceuticals/20090421/NY0216821042009-1.html
Sunday, April 12, 2009
Celsion Announces Promising Phase I ThermoDox(R) Results In Breast Cancer Presented At The Annual Meeting Of The Society For Thermal Medicine
Celsion Corporation (NASDAQ: CLSN) today announced that promising Phase I clinical results evaluating ThermoDox for the treatment of recurrent chest wall (RCW) breast cancer were presented by Duke University investigators on Sunday, April 5 at the 2009 Annual Meeting of the Society for Thermal Medicine (STM) in Tucson, Arizona.
Duke University Medical Center, Department of Radiation Oncology, Clinical Associate Professors Ellen Jones, PhD, MD, and Zeljko Vujaskovic, MD, PhD presented results from the Phase 1 study being conducted at Duke University Medical Center under the leadership of Kimberly Blackwell, MD, Division of Medical Oncology, through a grant jointly sponsored by Celsion and the National Institutes of Health. This Phase I study is designed to determine the maximum tolerated dose of ThermoDox when used in combination with microwave hyperthermia to treat mastectomy patients with RCW breast cancer.
To date sixteen patients have been treated with ThermoDox at doses ranging from 20 mg/m² to 40 mg/m². ThermoDox has demonstrated positive clinical activity in all of the evaluable patients.
"Based on the current data from our Phase I study that was presented at the STM, we are encouraged by the preliminary results of ThermoDox for the treatment of RCW breast cancer and look forward to determining the maximum tolerated dose and taking ThermoDox into the next stages of development," stated Ellen Jones PhD, MD, co-investigator at Duke University Medical Center. Zeljko Vujaskovic, MD, PhD, at Duke University Medical Center and also a co-investigator for the study, added, "I am optimistic regarding the data that has been presented on microwave hyperthermia combined with ThermoDox. We are eager to learn more about this novel approach to treating women with RCW breast cancer."
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "We are pleased that the oncology team at Duke University Medical Center fully supports the continued development of ThermoDox. RCW breast cancer is a debilitating disease for afflicted women. We are grateful for their commitment to this important work and look forward to their participation in our on-going Phase I/II pivotal study. With our current cash balance and the June 2009 $15 million payment from Boston Scientific for the purchase of Celsion's medical device assets, we believe that Celsion has the funds sufficient to fully enroll this important trial."
Concurrent with the Duke Phase I study, Celsion has commenced a pivotal Phase I/II open-label trial for ThermoDox in the treatment of RCW breast cancer that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the United States and to complete the Phase I portion of the study this year. Additional information on the study may be found at http://www.clinicaltrials.gov.
About Breast Cancer Recurrence at the Chest Wall
Depending on risk factors, up to 40% of women with mastectomies may experience breast cancer recurrence at the chest wall. The disease is a highly aggressive form of cancer and is generally defined as the recurrence of tumor to the area of the initial definitive treatment such as mastectomy. There are a significant number of women diagnosed with breast cancer recurrence at the chest wall that have exhausted all treatment options and cannot be treated with further surgical resection, radiation, or existing chemotherapy.
About ThermoDox®
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox and is conducting a pivotal global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.
About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com.
ThermoDox® is a registered trademark of Celsion Corporation
Original link:
http://www.medicalnewstoday.com/articles/145447.php
Duke University Medical Center, Department of Radiation Oncology, Clinical Associate Professors Ellen Jones, PhD, MD, and Zeljko Vujaskovic, MD, PhD presented results from the Phase 1 study being conducted at Duke University Medical Center under the leadership of Kimberly Blackwell, MD, Division of Medical Oncology, through a grant jointly sponsored by Celsion and the National Institutes of Health. This Phase I study is designed to determine the maximum tolerated dose of ThermoDox when used in combination with microwave hyperthermia to treat mastectomy patients with RCW breast cancer.
To date sixteen patients have been treated with ThermoDox at doses ranging from 20 mg/m² to 40 mg/m². ThermoDox has demonstrated positive clinical activity in all of the evaluable patients.
"Based on the current data from our Phase I study that was presented at the STM, we are encouraged by the preliminary results of ThermoDox for the treatment of RCW breast cancer and look forward to determining the maximum tolerated dose and taking ThermoDox into the next stages of development," stated Ellen Jones PhD, MD, co-investigator at Duke University Medical Center. Zeljko Vujaskovic, MD, PhD, at Duke University Medical Center and also a co-investigator for the study, added, "I am optimistic regarding the data that has been presented on microwave hyperthermia combined with ThermoDox. We are eager to learn more about this novel approach to treating women with RCW breast cancer."
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "We are pleased that the oncology team at Duke University Medical Center fully supports the continued development of ThermoDox. RCW breast cancer is a debilitating disease for afflicted women. We are grateful for their commitment to this important work and look forward to their participation in our on-going Phase I/II pivotal study. With our current cash balance and the June 2009 $15 million payment from Boston Scientific for the purchase of Celsion's medical device assets, we believe that Celsion has the funds sufficient to fully enroll this important trial."
Concurrent with the Duke Phase I study, Celsion has commenced a pivotal Phase I/II open-label trial for ThermoDox in the treatment of RCW breast cancer that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the United States and to complete the Phase I portion of the study this year. Additional information on the study may be found at http://www.clinicaltrials.gov.
About Breast Cancer Recurrence at the Chest Wall
Depending on risk factors, up to 40% of women with mastectomies may experience breast cancer recurrence at the chest wall. The disease is a highly aggressive form of cancer and is generally defined as the recurrence of tumor to the area of the initial definitive treatment such as mastectomy. There are a significant number of women diagnosed with breast cancer recurrence at the chest wall that have exhausted all treatment options and cannot be treated with further surgical resection, radiation, or existing chemotherapy.
About ThermoDox®
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox and is conducting a pivotal global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.
About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com.
ThermoDox® is a registered trademark of Celsion Corporation
Original link:
http://www.medicalnewstoday.com/articles/145447.php
Tuesday, March 24, 2009
Boron Liposomes
A very interesting article about development of boron based liposomes. To read the article click the link below.... Interesting work...
http://pubs.acs.org/cen/coverstory/87/8712cover.html
http://pubs.acs.org/cen/coverstory/87/8712cover.html
Thursday, March 19, 2009
New System Minimizes Pesticide Pollution Of Aquifers
ScienceDaily (Mar. 12, 2009) — One of the effects of the application of pesticides and herbicides in agriculture is the pollution of aquifers, because the pesticide is carried by irrigation water or rain along the soil profile (leaching). Minimizing such contamination is possible adjusting the maximum dose of herbicide. Nevertheless, it is difficult to totally avoid it because sooner or later the chemical will be dragged by the water.
Another problem is that when applying pesticides by spray part of their molecules are
volatilized. Failure to comply with strict security measures implies risk for people who repeatedly apply the compounds as they are exposed to the neurotoxic effects of some of these substances.
Scientists in the Institute of Natural Resources and Agrobiology of the Spanish National Research Council (CSIC) have developed a method to encapsulate and slowly release pesticides so that prevents the leaching as well as the volatilization of their molecules.
Tomas Undabeytia, principal investigator of this project, explains that the new method encapsulates the pesticide in lecithin liposomes or vesicles, which in turn are fixed on the surface (adsorption) of clay. The final product is a complex that combines liposomes, pesticide and clay and, at a first glance, looks like clay powder. This complex, which is dispersed in water, allows the chemical compound to be slowly released, as it is fixed to the clay. This also prevents the compound to be washed away by irrigation water or rainfall to subsurface layers and aquifers.
Although the formulation has been designed for agricultural products, it could be applied to other areas, such as mosquito lotions. The components of this formulation, the lipid to form liposome and the clay mineral, are classified by the Environmental Protection Agency of USA (USEPA) as substances of minimal toxicological concern.
Fewer doses, more time, less cost
The new development allows a safer pesticide formulation, thus avoiding repetitive applications or the need for higher doses and reducing the risk of contamination of water and soil while maintaining the desired effect of the pesticide on the target.
One of the major advantages of this system, as the authors explains, is that this formulation can be applied to molecules of pesticides of any kind, either hydrophobic, or acidic or basic. This greatly reduces complications. Experts know that when talking about pesticides, the interaction between chemicals and different soil types must be taken into account. For example, in Mediterranean agricultural areas predominates the calcareous soils. These kind of soils do not retain the anionic herbicide, which means that once there is an excess of water, then all the pesticide is leached to lower layers of soil. On the other hand, there are some new herbicides developed to minimize the required dose and reduce these pollution problems. But they are precisely anionic herbicides, which leach easily into calcareous soils. So, depending on the physico-chemical properties of the soil, the potential benefits of these last generation of herbicides can be lost. This is just one example that demonstrates why it is so important to obtain a slow release system, as these researchers have developed, able to be applied to any molecule of pesticide.
Source: http://www.sciencedaily.com/releases/2009/03/090306084639.htm
Another problem is that when applying pesticides by spray part of their molecules are
volatilized. Failure to comply with strict security measures implies risk for people who repeatedly apply the compounds as they are exposed to the neurotoxic effects of some of these substances.
Scientists in the Institute of Natural Resources and Agrobiology of the Spanish National Research Council (CSIC) have developed a method to encapsulate and slowly release pesticides so that prevents the leaching as well as the volatilization of their molecules.
Tomas Undabeytia, principal investigator of this project, explains that the new method encapsulates the pesticide in lecithin liposomes or vesicles, which in turn are fixed on the surface (adsorption) of clay. The final product is a complex that combines liposomes, pesticide and clay and, at a first glance, looks like clay powder. This complex, which is dispersed in water, allows the chemical compound to be slowly released, as it is fixed to the clay. This also prevents the compound to be washed away by irrigation water or rainfall to subsurface layers and aquifers.
Although the formulation has been designed for agricultural products, it could be applied to other areas, such as mosquito lotions. The components of this formulation, the lipid to form liposome and the clay mineral, are classified by the Environmental Protection Agency of USA (USEPA) as substances of minimal toxicological concern.
Fewer doses, more time, less cost
The new development allows a safer pesticide formulation, thus avoiding repetitive applications or the need for higher doses and reducing the risk of contamination of water and soil while maintaining the desired effect of the pesticide on the target.
One of the major advantages of this system, as the authors explains, is that this formulation can be applied to molecules of pesticides of any kind, either hydrophobic, or acidic or basic. This greatly reduces complications. Experts know that when talking about pesticides, the interaction between chemicals and different soil types must be taken into account. For example, in Mediterranean agricultural areas predominates the calcareous soils. These kind of soils do not retain the anionic herbicide, which means that once there is an excess of water, then all the pesticide is leached to lower layers of soil. On the other hand, there are some new herbicides developed to minimize the required dose and reduce these pollution problems. But they are precisely anionic herbicides, which leach easily into calcareous soils. So, depending on the physico-chemical properties of the soil, the potential benefits of these last generation of herbicides can be lost. This is just one example that demonstrates why it is so important to obtain a slow release system, as these researchers have developed, able to be applied to any molecule of pesticide.
Source: http://www.sciencedaily.com/releases/2009/03/090306084639.htm
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