Versar, a global project management company providing sustainable value oriented solutions to government and commercial clients, announced today that it has been awarded a 5-year, $4.8 million contract from the U.S. Environmental Protection Agency (EPA) Office of Water to conduct scientific peer reviews of EPA documents, assessments, and tools to guarantee that major scientific products receive critical review prior to dissemination or use by the EPA. The peer review program will include human health and ecological criteria, health advisories, engineering analyses, and remediation strategies.
Over the past 12 months, Versar has been awarded contracts with EPA’s Office of Research and Development and with the US Food and Drug Administration (FDA), making this Versar’s third peer review contract win. The other two contracts stipulate that Versar provides similar peer review support, including assembling expert panels to review EPA’s and FDA’s scientific products. In addition, Versar will organize meetings and workshops, prepare risk assessments, conduct literature reviews, and other technical and scientific assistance.
Mr. Jeff Moran, Senior Vice President Environmental Services of Versar, said, “We are very pleased to have been selected for another peer review contract supporting a major Federal agency. EPA and FDA continue to rely on Versar to ensure the quality of major scientific and technical products. We look forward to supporting EPA and FDA these next five years with their peer review needs through these three contracts.”
For further information, visit www.versar.com
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Thursday, August 1, 2013
Cardium Therapeutics, Inc. (CXM) Enters Distribution Agreement Targeting Governmental Medical Facilities
Today before the open, Cardium Therapeutics announced that it has signed a distribution agreement with AvKARE encompassing government medical facilities throughout the United States. The new commercialization arrangement with AvKARE effectively replaces an earlier arrangement with Academy Medical.
Cardium chose to transfer the Excellagen distribution responsibilities to AvKARE, a licensed manufacturer/wholesaler of pharmaceuticals, disposable medical supplies, and capital medical equipment. The officers and management team at AvKARE have more than 80 years’ experience in the pharmaceutical and medical supply industry.
As part of the agreement, AvKARE provides five direct wound care experts and allows Cardium’s 25 distributor representatives access to all government accounts. The company serves the Department of Defense, Veterans Hospitals, NASA, TriCare, Dept. of Agriculture, Indian Health Services, USDA, U.S. Army, Air Force, Navy, and USMC, as well as Group Purchasing Organizations that include Amerinet, Innovatix, Health Trust Purchasing Group, IPC, Broadlane/MedAssets and Premier.
To learn more about AvKARE, visit www.Excellagen.com/AvKARE
To learn more about Cardium, visit www.CardiumTHX.com
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Cardium chose to transfer the Excellagen distribution responsibilities to AvKARE, a licensed manufacturer/wholesaler of pharmaceuticals, disposable medical supplies, and capital medical equipment. The officers and management team at AvKARE have more than 80 years’ experience in the pharmaceutical and medical supply industry.
As part of the agreement, AvKARE provides five direct wound care experts and allows Cardium’s 25 distributor representatives access to all government accounts. The company serves the Department of Defense, Veterans Hospitals, NASA, TriCare, Dept. of Agriculture, Indian Health Services, USDA, U.S. Army, Air Force, Navy, and USMC, as well as Group Purchasing Organizations that include Amerinet, Innovatix, Health Trust Purchasing Group, IPC, Broadlane/MedAssets and Premier.
To learn more about AvKARE, visit www.Excellagen.com/AvKARE
To learn more about Cardium, visit www.CardiumTHX.com
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Arkansas Baptist Schools Deploy Several Meru Networks, Inc. (MERU) Wi-Fi Solutions
Meru Networks announced that Arkansas Baptist Schools has deployed a Meru Education-grade (MEG™) wireless solution across two separate campuses. The deployment includes Meru’s Identity Manager solution for easy and secure on-boarding of student-owned and guest-owned mobile devices, which will assist in providing unlimited access to learning opportunities.
The school selected the Wi-Fi networking leader because of the Meru MobileFLEX’s effective and simple architecture. Its optional single-channel, virtual cell implementation helps maintain mobility between access points, with none of the “sticky client” or “call-dropping” issues that traditional multi-channel implementations can impose. Additionally, the school’s small IT staff was able to install and manage the network without any issues, enabling full coverage at both its lower-school and upper-school campuses.
“Arkansas Baptist Schools is using Wi-Fi to truly transform its campus and strive for uninterrupted learning,” remarked Sarosh Vesuna, vice president and general manager of the education and healthcare business units at Meru. “The flexibility, ease of use and ease of management that the MEG solution provides will help ensure that students, faculty and staff will have the information they need, when they need it, no matter where they are or what device they are using.”
Meru’s Identity Manager BYOD and guest-access solution greatly simplifies on-boarding of the student-owned mobile devices. These devices include smartphones, laptops, tablets, and notebook computers; securely on-boarding these devices manually would be impossible for the school’s very small IT team, and fast connectivity means maximizing classroom instruction time.
“Bringing in the Meru solution was the first step in our implementing a BYOD policy at the school,” said Brian C. Mashburn, PhD., director of technology for Arkansas Baptist. “That program is critical to us, in that it actually changes the learning experience for each of these students in a real way, in a way that they live today. It gives them access to any information, anywhere, all the time. We need them to be able to pursue this academic process whether they’re in the classroom, the hallway, or on vacation, and the Meru network helps us ensure that they can.”
For more information on the company and its Wi-Fi network solutions, please visit www.merunetworks.com
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The school selected the Wi-Fi networking leader because of the Meru MobileFLEX’s effective and simple architecture. Its optional single-channel, virtual cell implementation helps maintain mobility between access points, with none of the “sticky client” or “call-dropping” issues that traditional multi-channel implementations can impose. Additionally, the school’s small IT staff was able to install and manage the network without any issues, enabling full coverage at both its lower-school and upper-school campuses.
“Arkansas Baptist Schools is using Wi-Fi to truly transform its campus and strive for uninterrupted learning,” remarked Sarosh Vesuna, vice president and general manager of the education and healthcare business units at Meru. “The flexibility, ease of use and ease of management that the MEG solution provides will help ensure that students, faculty and staff will have the information they need, when they need it, no matter where they are or what device they are using.”
Meru’s Identity Manager BYOD and guest-access solution greatly simplifies on-boarding of the student-owned mobile devices. These devices include smartphones, laptops, tablets, and notebook computers; securely on-boarding these devices manually would be impossible for the school’s very small IT team, and fast connectivity means maximizing classroom instruction time.
“Bringing in the Meru solution was the first step in our implementing a BYOD policy at the school,” said Brian C. Mashburn, PhD., director of technology for Arkansas Baptist. “That program is critical to us, in that it actually changes the learning experience for each of these students in a real way, in a way that they live today. It gives them access to any information, anywhere, all the time. We need them to be able to pursue this academic process whether they’re in the classroom, the hallway, or on vacation, and the Meru network helps us ensure that they can.”
For more information on the company and its Wi-Fi network solutions, please visit www.merunetworks.com
About MissionIR
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Sign up for “The Mission Report” at www.MissionIR.com
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CytRx Corp. (CYTR) to Present at the European Society for Medical Oncology Conference in Amsterdam
CytRx, a biopharmaceutical research and development company specializing in oncology, announced this month that its more potent version of the widely used chemotherapeutic agent doxorubicin, aldoxorubicin, demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. Favorable results from this confirmatory trial - conducted in collaboration with Louisiana State University (LSU) School of Medicine - are set to be presented next month in Amsterdam at the European Society for Medical Oncology.
“We are surprised and excited about the effectiveness demonstrated by aldoxorubicin in this particularly difficult-to-treat cancer,” commented Om Prakash, Ph.D., the study’s principal investigator and Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center, New Orleans. “It has been well documented that doxorubicin, although active against glioblastoma cancer cells in tissue culture, does not cross the blood-brain barrier, the body’s natural defense system protecting the brain, to effectively treat patients with brain tumors. In fact, in our study doxorubicin was no more effective than saline in suppressing glioblastoma tumor growth. We have shown that aldoxorubicin uptake is confined only to the tumor in the brain and does not enter normal brain tissue. Thus, we would expect toxicity in the central nervous system to be negligible. Our conclusion from this trial is that aldoxorubicin has the potential to safely shrink glioblastoma tumors which could dramatically prolong the average survival time in patients. We initially had observed a similar effect of aldoxorubicin on glioblastoma in a preliminary study, and are quite pleased to have confirmed the result in a larger, well-controlled study that included native doxorubicin.”
Shown to be superior to doxorubicin in seven different tumor types and animal models of cancer, including ovarian, lung, breast, and pancreatic cancer, as well as multiple myeloma, aldoxorubicin has also demonstrated activity in human trials for the treatment of soft tissue sarcomas and other cancers. CytRx has chosen aldoxorubicin as the first drug candidate the company is developing based on a novel linker technology that has proven ability to allow attachment of multiple chemotherapeutic agents and is designed to provide both greater anti-cancer activity and to mitigate the toxicity that limits these agents’ use.
CytRx is well known for its many clinical programs related to the treatment of tumors. The company actively promotes its findings by speaking at several gatherings within the healthcare field, such as the Annual ROTH conference; the Leerink Swann Global Healthcare conference; and the Biotech Showcase 2013 conference. Most recently, CytRx presented at the American Society of Clinical Oncology (ASCO) conference in Chicago, focusing on favorable findings from a Phase 1b clinical trial regarding the combination of aldoxorubicin and doxorubicin.
For more information on CytRx, please visit www.cytrx.com
CytRx Corp. (CYTR) to Present at the European Society for Medical Oncology Conference in Amsterdam
CytRx, a biopharmaceutical research and development company specializing in oncology, announced this month that its more potent version of the widely used chemotherapeutic agent doxorubicin, aldoxorubicin, demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. Favorable results from this confirmatory trial - conducted in collaboration with Louisiana State University (LSU) School of Medicine - are set to be presented next month in Amsterdam at the European Society for Medical Oncology.
“We are surprised and excited about the effectiveness demonstrated by aldoxorubicin in this particularly difficult-to-treat cancer,” commented Om Prakash, Ph.D., the study’s principal investigator and Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center, New Orleans. “It has been well documented that doxorubicin, although active against glioblastoma cancer cells in tissue culture, does not cross the blood-brain barrier, the body’s natural defense system protecting the brain, to effectively treat patients with brain tumors. In fact, in our study doxorubicin was no more effective than saline in suppressing glioblastoma tumor growth. We have shown that aldoxorubicin uptake is confined only to the tumor in the brain and does not enter normal brain tissue. Thus, we would expect toxicity in the central nervous system to be negligible. Our conclusion from this trial is that aldoxorubicin has the potential to safely shrink glioblastoma tumors which could dramatically prolong the average survival time in patients. We initially had observed a similar effect of aldoxorubicin on glioblastoma in a preliminary study, and are quite pleased to have confirmed the result in a larger, well-controlled study that included native doxorubicin.”
Shown to be superior to doxorubicin in seven different tumor types and animal models of cancer, including ovarian, lung, breast, and pancreatic cancer, as well as multiple myeloma, aldoxorubicin has also demonstrated activity in human trials for the treatment of soft tissue sarcomas and other cancers. CytRx has chosen aldoxorubicin as the first drug candidate the company is developing based on a novel linker technology that has proven ability to allow attachment of multiple chemotherapeutic agents and is designed to provide both greater anti-cancer activity and to mitigate the toxicity that limits these agents’ use.
CytRx is well known for its many clinical programs related to the treatment of tumors. The company actively promotes its findings by speaking at several gatherings within the healthcare field, such as the Annual ROTH conference; the Leerink Swann Global Healthcare conference; and the Biotech Showcase 2013 conference. Most recently, CytRx presented at the American Society of Clinical Oncology (ASCO) conference in Chicago, focusing on favorable findings from a Phase 1b clinical trial regarding the combination of aldoxorubicin and doxorubicin.
For more information on CytRx, please visit www.cytrx.com
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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
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“We are surprised and excited about the effectiveness demonstrated by aldoxorubicin in this particularly difficult-to-treat cancer,” commented Om Prakash, Ph.D., the study’s principal investigator and Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center, New Orleans. “It has been well documented that doxorubicin, although active against glioblastoma cancer cells in tissue culture, does not cross the blood-brain barrier, the body’s natural defense system protecting the brain, to effectively treat patients with brain tumors. In fact, in our study doxorubicin was no more effective than saline in suppressing glioblastoma tumor growth. We have shown that aldoxorubicin uptake is confined only to the tumor in the brain and does not enter normal brain tissue. Thus, we would expect toxicity in the central nervous system to be negligible. Our conclusion from this trial is that aldoxorubicin has the potential to safely shrink glioblastoma tumors which could dramatically prolong the average survival time in patients. We initially had observed a similar effect of aldoxorubicin on glioblastoma in a preliminary study, and are quite pleased to have confirmed the result in a larger, well-controlled study that included native doxorubicin.”
Shown to be superior to doxorubicin in seven different tumor types and animal models of cancer, including ovarian, lung, breast, and pancreatic cancer, as well as multiple myeloma, aldoxorubicin has also demonstrated activity in human trials for the treatment of soft tissue sarcomas and other cancers. CytRx has chosen aldoxorubicin as the first drug candidate the company is developing based on a novel linker technology that has proven ability to allow attachment of multiple chemotherapeutic agents and is designed to provide both greater anti-cancer activity and to mitigate the toxicity that limits these agents’ use.
CytRx is well known for its many clinical programs related to the treatment of tumors. The company actively promotes its findings by speaking at several gatherings within the healthcare field, such as the Annual ROTH conference; the Leerink Swann Global Healthcare conference; and the Biotech Showcase 2013 conference. Most recently, CytRx presented at the American Society of Clinical Oncology (ASCO) conference in Chicago, focusing on favorable findings from a Phase 1b clinical trial regarding the combination of aldoxorubicin and doxorubicin.
For more information on CytRx, please visit www.cytrx.com
CytRx Corp. (CYTR) to Present at the European Society for Medical Oncology Conference in Amsterdam
CytRx, a biopharmaceutical research and development company specializing in oncology, announced this month that its more potent version of the widely used chemotherapeutic agent doxorubicin, aldoxorubicin, demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. Favorable results from this confirmatory trial - conducted in collaboration with Louisiana State University (LSU) School of Medicine - are set to be presented next month in Amsterdam at the European Society for Medical Oncology.
“We are surprised and excited about the effectiveness demonstrated by aldoxorubicin in this particularly difficult-to-treat cancer,” commented Om Prakash, Ph.D., the study’s principal investigator and Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University Health Sciences Center, New Orleans. “It has been well documented that doxorubicin, although active against glioblastoma cancer cells in tissue culture, does not cross the blood-brain barrier, the body’s natural defense system protecting the brain, to effectively treat patients with brain tumors. In fact, in our study doxorubicin was no more effective than saline in suppressing glioblastoma tumor growth. We have shown that aldoxorubicin uptake is confined only to the tumor in the brain and does not enter normal brain tissue. Thus, we would expect toxicity in the central nervous system to be negligible. Our conclusion from this trial is that aldoxorubicin has the potential to safely shrink glioblastoma tumors which could dramatically prolong the average survival time in patients. We initially had observed a similar effect of aldoxorubicin on glioblastoma in a preliminary study, and are quite pleased to have confirmed the result in a larger, well-controlled study that included native doxorubicin.”
Shown to be superior to doxorubicin in seven different tumor types and animal models of cancer, including ovarian, lung, breast, and pancreatic cancer, as well as multiple myeloma, aldoxorubicin has also demonstrated activity in human trials for the treatment of soft tissue sarcomas and other cancers. CytRx has chosen aldoxorubicin as the first drug candidate the company is developing based on a novel linker technology that has proven ability to allow attachment of multiple chemotherapeutic agents and is designed to provide both greater anti-cancer activity and to mitigate the toxicity that limits these agents’ use.
CytRx is well known for its many clinical programs related to the treatment of tumors. The company actively promotes its findings by speaking at several gatherings within the healthcare field, such as the Annual ROTH conference; the Leerink Swann Global Healthcare conference; and the Biotech Showcase 2013 conference. Most recently, CytRx presented at the American Society of Clinical Oncology (ASCO) conference in Chicago, focusing on favorable findings from a Phase 1b clinical trial regarding the combination of aldoxorubicin and doxorubicin.
For more information on CytRx, please visit www.cytrx.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website
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Mandalay Digital Group, Inc. (MNDL) Reveals Upcoming Launch, Expansion and Integration of Digital Turbine Services
Mandalay Digital Group, a global media and communications company with distribution partnerships that span over 70 carriers in 28 countries, recently announced two major developments relating to its Digital Turbine services.
On July 17, Mandalay Digital announced plans to integrate its mobile application management solution, Digital Turbine Ignite, with US Wireless operator Cricket. The new Ignite platform will provide Cricket the ability to manage and control its pre and post app installations on Cricket’s forthcoming Android device.
“Our work with Cricket in launching Digital Turbine Ignite is particularly exciting as global carriers continue to integrate our next-generation solutions to better manage and monetize mobile content,” said Peter Adderton, Chief Executive Officer of Mandalay Digital Group. “We look forward to a successful trial launch with this first device to validate the US market opportunity for both Cricket and Digital Turbine Ignite.”
On July 22, Mandalay Digital revealed the upcoming digital launch of its Digital Turbine IQ, as well as the expansion of Digital Turbine’s content management, Digital Turbine Content, on Telstra devices. Digital Turbine IQ provides users with a fully integrated experience and multimedia management interface and is to be deployed on Telstra’s Android smartphones later this year. Additionally, Digital Turbine will include all of Telstra’s mobile gaming and music download services, expanding its content management relationship with Telstra.
“Our expanded partnership with Telstra is particularly exciting as global carriers continue to integrate our next-generation solutions to better manage and monetize mobile content,” commented Peter Adderton, Chief Executive Officer of Mandalay Digital Group. “Through our mobile content solutions, Digital Turbine puts power back in the hands of the operators allowing them to control and monetize part of the application process.”
For additional information on Mandalay Digital Group, please visit www.mandalaydigital.com
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On July 17, Mandalay Digital announced plans to integrate its mobile application management solution, Digital Turbine Ignite, with US Wireless operator Cricket. The new Ignite platform will provide Cricket the ability to manage and control its pre and post app installations on Cricket’s forthcoming Android device.
“Our work with Cricket in launching Digital Turbine Ignite is particularly exciting as global carriers continue to integrate our next-generation solutions to better manage and monetize mobile content,” said Peter Adderton, Chief Executive Officer of Mandalay Digital Group. “We look forward to a successful trial launch with this first device to validate the US market opportunity for both Cricket and Digital Turbine Ignite.”
On July 22, Mandalay Digital revealed the upcoming digital launch of its Digital Turbine IQ, as well as the expansion of Digital Turbine’s content management, Digital Turbine Content, on Telstra devices. Digital Turbine IQ provides users with a fully integrated experience and multimedia management interface and is to be deployed on Telstra’s Android smartphones later this year. Additionally, Digital Turbine will include all of Telstra’s mobile gaming and music download services, expanding its content management relationship with Telstra.
“Our expanded partnership with Telstra is particularly exciting as global carriers continue to integrate our next-generation solutions to better manage and monetize mobile content,” commented Peter Adderton, Chief Executive Officer of Mandalay Digital Group. “Through our mobile content solutions, Digital Turbine puts power back in the hands of the operators allowing them to control and monetize part of the application process.”
For additional information on Mandalay Digital Group, please visit www.mandalaydigital.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website
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Galena Biopharma, Inc. (GALE) Data from Phase Ib Trial of FBP Peptide Vaccine is Very Encouraging
As biopharmaceutical company Galena Biopharma continues the dose escalation Phase Ib trial of its FBP peptide vaccine, positive data have been reported from the first 20 enrolled patients.
Similar to the company’s NeuVax vaccine for breast cancer, the FBP vaccine provides a key peptide that is recognized by T-cells, driving an immune response against cancer cells. Galena has observed a 59.3% reduction so far in ovarian cancer recurrence rates among patients who have received the vaccine.
Based on the same technology as NeuVax, which is Galena’s lead Phase III product candidate and a vaccine for Her2 1/2+ breast cancer, the FBP vaccine provides an immunogenic peptide (E39 peptide of folate binding protein) that is presented by dendritic cells to T-cells specifically in patients who express the human leukocyte antigen-A2 (HLA-A2). This study will enroll approximately 60 patients who have either ovarian or endometrial cancer, and the patients will be tested for their HLA-A2 status. Those testing HLA-A2+ will be randomized to receive, in six monthly intradermal injections, one of three doses of the E39 peptide (100/500/1,000 mcg) plus 250 mcg GM-CSF, which is an immune-activating adjuvant. Together, the peptide and GM-CSF are referred to as the “FBP vaccine.” As a control, HLA-A2- patients will be followed as matched cohort controls, but these patients will not receive any additional therapy aside from standard of care. The Phase Ib trial’s primary endpoint is to determine safety and dose-limiting toxicities.
Data from the first 20 patients enrolled in the trial show that patients receiving the FBP vaccine have a lower disease recurrence rate – 11.1% contrasted with the 27.3% recurrence rate among patients that did not receive the vaccine. This represents a 59.3% reduction in disease recurrence.
For 36 months, patients will be followed for disease-free status. Throughout the trial, all patients are being monitored for vaccine activity markers, including the telling “DTH” response, which is a swelling at the injection site, and T-cell activity; both have been observed to correlate with survival in patients vaccinated with NeuVax.
These data from the trial are an early glimpse of the FBP vaccine’s overall impact, as the trial is presently only one-third enrolled. The company, however, views these preliminary results as very encouraging indicators that the vaccine will continue progressing in clinical development and likely show a trend toward effectiveness.
Though these data represent only an upside to Galena’s projections at this point, the company considers these positive preliminary results to be a validation of its vaccine approach. As Galena has seen with NeuVax, highly immunogenic peptide vaccines can stimulate strong immune responses, which may prevent the recurrence of cancer.
A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.
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Please see disclaimer on the MissionIR website
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Similar to the company’s NeuVax vaccine for breast cancer, the FBP vaccine provides a key peptide that is recognized by T-cells, driving an immune response against cancer cells. Galena has observed a 59.3% reduction so far in ovarian cancer recurrence rates among patients who have received the vaccine.
Based on the same technology as NeuVax, which is Galena’s lead Phase III product candidate and a vaccine for Her2 1/2+ breast cancer, the FBP vaccine provides an immunogenic peptide (E39 peptide of folate binding protein) that is presented by dendritic cells to T-cells specifically in patients who express the human leukocyte antigen-A2 (HLA-A2). This study will enroll approximately 60 patients who have either ovarian or endometrial cancer, and the patients will be tested for their HLA-A2 status. Those testing HLA-A2+ will be randomized to receive, in six monthly intradermal injections, one of three doses of the E39 peptide (100/500/1,000 mcg) plus 250 mcg GM-CSF, which is an immune-activating adjuvant. Together, the peptide and GM-CSF are referred to as the “FBP vaccine.” As a control, HLA-A2- patients will be followed as matched cohort controls, but these patients will not receive any additional therapy aside from standard of care. The Phase Ib trial’s primary endpoint is to determine safety and dose-limiting toxicities.
Data from the first 20 patients enrolled in the trial show that patients receiving the FBP vaccine have a lower disease recurrence rate – 11.1% contrasted with the 27.3% recurrence rate among patients that did not receive the vaccine. This represents a 59.3% reduction in disease recurrence.
For 36 months, patients will be followed for disease-free status. Throughout the trial, all patients are being monitored for vaccine activity markers, including the telling “DTH” response, which is a swelling at the injection site, and T-cell activity; both have been observed to correlate with survival in patients vaccinated with NeuVax.
These data from the trial are an early glimpse of the FBP vaccine’s overall impact, as the trial is presently only one-third enrolled. The company, however, views these preliminary results as very encouraging indicators that the vaccine will continue progressing in clinical development and likely show a trend toward effectiveness.
Though these data represent only an upside to Galena’s projections at this point, the company considers these positive preliminary results to be a validation of its vaccine approach. As Galena has seen with NeuVax, highly immunogenic peptide vaccines can stimulate strong immune responses, which may prevent the recurrence of cancer.
A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website
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Senior Biotechnology Analyst Provides Personal Perspective on Galena Biopharma, Inc. (GALE)
In a recent article published by The Life Sciences Report, Cantor Fitzgerald Senior Biotechnology Analyst Mara Goldstein shared her view of Galena Biopharma. The interview is provided below.
The Life Sciences Report: You are following Galena Biopharma Inc. (GALE:NASDAQ). We’ve discussed it before. Tell me your growth theory.
Mara Goldstein: Galena’s clinical program is immunotherapeutic, and the technology is peptide-based vaccines. It is developing NeuVax (nelipepimut-S or E75) to prevent recurrence of breast cancer in women who have been treated for early-stage disease and are at risk for recurrence. The company opened a 700-patient, phase 3 trial called PRESENT last year, and is enrolling patients now. Some interesting data have been generated around this vaccine from earlier studies, but obviously, it needs to demonstrate efficacy in the phase 3.
Galena has another peptide-based vaccine, folate-binding protein E39, which is in early development for ovarian and endometrial cancers that overexpress folate-binding protein (FBP). FBP is significantly overexpressed in the vast majority of ovarian and endometrial cancers, and to a lesser degree in breast, lung, colorectal and renal cell carcinomas. Because of limited distribution of FBP in healthy tissues, it is an interesting target.
Most recently, Galena purchased product rights to Abstral (fentanyl; sublingual tablets) from Orexo AB (ORX:STO). Abstral’s target market is palliative care of patients with breakthrough cancer pain in the U.S. This provides Galena with the opportunity build a commercial organization, develop a marketing plan and begin to build relationships with oncologists, purchasers and payers.
TLSR: The sublingual narcotic Abstral doesn’t really fit Galena’s scientific model, but it fits the business model, with sales personnel set to get into the oncology office or clinic. Does this imply that the company wants to market NeuVax when and if the product is approved?
MG: I believe that Galena wants to capture as much value from NeuVax as possible for its shareholders. I wouldn’t rule anything out at this point in time.
TLSR: The patients here are women who’ve had a brush with breast cancer, and you can imagine they are very motivated to prevent recurrence. I would presume that a great demand for NeuVax would exist if the product is approved. The immunization will occur in multiple doses. How much will it cost patients, or payers?
MG: Potential pricing for NeuVax has not been disclosed, and I imagine that Galena has and will continue to perform sensitivity analysis on pricing. But I would expect that if NeuVax is able to prevent cancer recurrence, particularly in distant spread of disease, it would alleviate a considerable burden on the healthcare system.
For example, take a drug like Kadcyla (ado-trastuzumab emtansine), which is sold by Roche and incorporates ImmunoGen Inc.’s (IMGN:NASDAQ) monoclonal antibody drug conjugate technology using Herceptin (trastuzumab) and a cytotoxic payload. Kadcyla was approved earlier this year for previously treated metastatic disease in women who have already received treatment with Herceptin. On an annual basis, the cost of Kadcyla is about $9,800/month, or more than $90,000/year. I think there’s a big range of pricing that could occur with NeuVax, and it’s a function of many factors.
TLSR: The phase 2 study of NeuVax did not show statistical significance. I understand that the phase 3 PRESENT study is designed a little differently, specifically to select out for the higher-risk patients where we should see some benefit if the product works. Could you talk about that just briefly?
MG: The standard of care for HER2-positive cancer changed during the NeuVax phase 2 study—namely, the use of Herceptin for the treatment of women with early-stage disease. Early studies also showed a waning immunological response over time. The program was amended to include booster dosing in women who were more than six months from completion of the initial vaccination schedule. Of the original group of patients receiving the vaccine in the phase 2 study, roughly half received booster doses at six-month intervals.
The work done so far does suggest there is activity with NeuVax, but a phase 3 trial is necessary to tease this out. There may be a level of risk that isn’t quite the same as seen in other clinical programs, given the changing protocol. But we find the immunological response to NeuVax quite interesting, as well as data that seems to point in the right direction.
TLSR: When could we be looking at approval of NeuVax. Does 2017 sound reasonable to you?
MG: It depends on the pace of enrollment and when the data roll out. 2017 might be the earliest, if enough events occur to get the trial to read out. That would be a best-case scenario.
TLSR: Investors have been focused on that NeuVax phase 3 trial, but since that study doesn’t have a near-term catalyst, do you think that FBP or perhaps even the investigator-sponsored trial with NeuVax + Herceptin could move shares?
MG: The phase 2 NeuVax + Herceptin trial has an opportunity to read out sooner than the PRESENT study, and could be a catalyst for investors.
But we also think that enrollment updates for the NeuVax PRESENT trial, as well as for the FBP trial, are catalysts for Galena. Another piece is that the company is planning to relaunch Abstral in Q4/13, which provides a different sort of catalyst—one pegged to revenue generation.
Source of the interview: http://dtg.fm/sON7
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The Life Sciences Report: You are following Galena Biopharma Inc. (GALE:NASDAQ). We’ve discussed it before. Tell me your growth theory.
Mara Goldstein: Galena’s clinical program is immunotherapeutic, and the technology is peptide-based vaccines. It is developing NeuVax (nelipepimut-S or E75) to prevent recurrence of breast cancer in women who have been treated for early-stage disease and are at risk for recurrence. The company opened a 700-patient, phase 3 trial called PRESENT last year, and is enrolling patients now. Some interesting data have been generated around this vaccine from earlier studies, but obviously, it needs to demonstrate efficacy in the phase 3.
Galena has another peptide-based vaccine, folate-binding protein E39, which is in early development for ovarian and endometrial cancers that overexpress folate-binding protein (FBP). FBP is significantly overexpressed in the vast majority of ovarian and endometrial cancers, and to a lesser degree in breast, lung, colorectal and renal cell carcinomas. Because of limited distribution of FBP in healthy tissues, it is an interesting target.
Most recently, Galena purchased product rights to Abstral (fentanyl; sublingual tablets) from Orexo AB (ORX:STO). Abstral’s target market is palliative care of patients with breakthrough cancer pain in the U.S. This provides Galena with the opportunity build a commercial organization, develop a marketing plan and begin to build relationships with oncologists, purchasers and payers.
TLSR: The sublingual narcotic Abstral doesn’t really fit Galena’s scientific model, but it fits the business model, with sales personnel set to get into the oncology office or clinic. Does this imply that the company wants to market NeuVax when and if the product is approved?
MG: I believe that Galena wants to capture as much value from NeuVax as possible for its shareholders. I wouldn’t rule anything out at this point in time.
TLSR: The patients here are women who’ve had a brush with breast cancer, and you can imagine they are very motivated to prevent recurrence. I would presume that a great demand for NeuVax would exist if the product is approved. The immunization will occur in multiple doses. How much will it cost patients, or payers?
MG: Potential pricing for NeuVax has not been disclosed, and I imagine that Galena has and will continue to perform sensitivity analysis on pricing. But I would expect that if NeuVax is able to prevent cancer recurrence, particularly in distant spread of disease, it would alleviate a considerable burden on the healthcare system.
For example, take a drug like Kadcyla (ado-trastuzumab emtansine), which is sold by Roche and incorporates ImmunoGen Inc.’s (IMGN:NASDAQ) monoclonal antibody drug conjugate technology using Herceptin (trastuzumab) and a cytotoxic payload. Kadcyla was approved earlier this year for previously treated metastatic disease in women who have already received treatment with Herceptin. On an annual basis, the cost of Kadcyla is about $9,800/month, or more than $90,000/year. I think there’s a big range of pricing that could occur with NeuVax, and it’s a function of many factors.
TLSR: The phase 2 study of NeuVax did not show statistical significance. I understand that the phase 3 PRESENT study is designed a little differently, specifically to select out for the higher-risk patients where we should see some benefit if the product works. Could you talk about that just briefly?
MG: The standard of care for HER2-positive cancer changed during the NeuVax phase 2 study—namely, the use of Herceptin for the treatment of women with early-stage disease. Early studies also showed a waning immunological response over time. The program was amended to include booster dosing in women who were more than six months from completion of the initial vaccination schedule. Of the original group of patients receiving the vaccine in the phase 2 study, roughly half received booster doses at six-month intervals.
The work done so far does suggest there is activity with NeuVax, but a phase 3 trial is necessary to tease this out. There may be a level of risk that isn’t quite the same as seen in other clinical programs, given the changing protocol. But we find the immunological response to NeuVax quite interesting, as well as data that seems to point in the right direction.
TLSR: When could we be looking at approval of NeuVax. Does 2017 sound reasonable to you?
MG: It depends on the pace of enrollment and when the data roll out. 2017 might be the earliest, if enough events occur to get the trial to read out. That would be a best-case scenario.
TLSR: Investors have been focused on that NeuVax phase 3 trial, but since that study doesn’t have a near-term catalyst, do you think that FBP or perhaps even the investigator-sponsored trial with NeuVax + Herceptin could move shares?
MG: The phase 2 NeuVax + Herceptin trial has an opportunity to read out sooner than the PRESENT study, and could be a catalyst for investors.
But we also think that enrollment updates for the NeuVax PRESENT trial, as well as for the FBP trial, are catalysts for Galena. Another piece is that the company is planning to relaunch Abstral in Q4/13, which provides a different sort of catalyst—one pegged to revenue generation.
Source of the interview: http://dtg.fm/sON7
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website
http://www.missionir.com/disclaimer.html
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