On June 8, 2015 Navidea Biopharmaceuticals reported that results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy were presented at the 2015 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference (Press release, Navidea Biopharmaceuticals, JUN 8, 2015, View Source;p=RssLanding&cat=news&id=2057359 [SID:1234505430]). The results of the randomized, double-blinded trial, led by Anne Wallace, M.D., professor of surgery at University of California, San Diego School of Medicine, highlighted that fTcSC caused statistically significant greater levels of pain after injection compared to Lymphoseek.

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In preparation for Sentinel Lymph Node Biopsy in breast cancer and other cancers, lymphatic pathways are mapped using a procedure called lymphoscintigraphy. "Patients often fear this procedure given the evidence of injection pain from some radiotracers," said Dr. Wallace, who is also director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center. "This study of tilmanocept demonstrated, with patient-reported data, a significantly reduced level of post-injection associated pain compared with use of an fTcSC tracer. Along with its other desirable performance characteristics, surgeons now have a reliable tool that can potentially play an important role in improved patient comfort and management."

"This investigator-initiated study is of particular importance as it continues to reinforce the clinical value of Lymphoseek," said Michael Tomblyn, M.D., Navidea’s Executive Medical Director. "While previous studies have reported on Lymphoseek efficacy and ongoing safety, these results further illustrate both the clinical utility and clear benefits to both surgical oncologists and patients."

The poster presentation entitled, "A Randomized Double-Blinded Comparison of Injection Site Pain of Tc-99m Tilmanocept versus Filtered Tc-99m Sulfur Colloid in Patients Undergoing Lymph Node Mapping for Breast Cancer" showed results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicates baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On June 8, 2015 Advaxis reported that results from an ongoing clinical study of ADXS-HER2 in canine osteosarcoma (OSA), were presented by principal investigator Nicola J. Mason, B.Vet.Med., Ph.D., DACVIM, Associate Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, at the 2015 American College of Veterinary Internal Medicine (ACVIM) Forum in Indianapolis, Ind., on June 6, 2015 (Press release, Advaxis, JUN 8, 2015, View Source [SID:1234505373]).

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The preliminary data presented at ACVIM demonstrate that ADXS-HER2, in combination with palliative radiation, delayed tumor progression and prolonged overall survival in a group of 12 pet dogs with treatment naïve spontaneous OSA. Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity. Of the 12 canine patients recruited to date, seven are alive with current survival times ranging from 66 to 479 days. The median survival time of dogs receiving palliative radiation plus ADXS-HER2 has not been reached. The median time to progression of these 12 canine patients is 238 days. The reported median survival time for historical control dogs with OSA that do not undergo amputation but instead receive the same palliative radiation protocol without ADXS-HER2 is 136 days. Preliminary results from the pilot study were recently presented by Dr. Mason at the 2015 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 20, 2015, at which point the study comprised a group of 10 canine patients.

"It is encouraging to see that ADXS-HER2 may have success as a cancer immunotherapy to treat dogs especially as it is associated with very few side effects," said Dr. Mason. "These results add to the growing body of data demonstrating the promising activity of ADXS-HER2."

Data from the first Phase 1 clinical trial in canine OSA were presented last year during the 2014 ACVIM Forum, which showed ADXS-HER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in canines with OSA that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At the time of the presentation, two-thirds of the treated canine patients were still alive and therefore a median survival time had not been reached. Conversely, historical control dogs that underwent standard of care and did not receive ADXS-HER2 had a median survival time of 316 days.

Advaxis licensed ADXS-HER2 to Aratana Therapeutics (NASDAQ:PETX) in March of 2014 for pet health indications and it is now being developed and prepared for commercialization using the name AT-014. Advaxis and Aratana anticipate conditional licensure of AT-014 for the treatment of canine OSA from the U.S. Department of Agriculture (USDA) in 2016.

Dr. Mason’s June 6, 2015 presentation at ACVIM is available on the Advaxis website at www.advaxis.com under the scientific presentations.

Translating Canine Clinical Research into Human Trials

The canine evidence with ADXS-HER2 may have important translational relevance for human patients with OSA and other HER2+ cancers, such as breast, gastric and esophageal. Advaxis expects to initiate a Phase 1b dose-escalation study of ADXS-HER2 in humans with HER2+ solid tumors in mid-2015. Once dosing is established in the human trial, Advaxis plans to work with Children’s Oncology Group (COG) to launch a pivotal trial in human pediatric OSA in early 2016. The COG, a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research.

HER2 is expressed in approximately 40-60 percent of pediatric and canine OSA and in pulmonary metastatic disease, suggesting that immune targeting of HER2 might delay or eliminate metastatic disease. The hypothesis warrants investigation and will be tested in the pivotal pediatric OSA trial. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival.

"Advaxis plans to translate this science into human patients, particularly in children with osteosarcoma," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "These data also demonstrate that our Lm Technology may offer an opportunity to address HER2+ tumors in pets. We look forward to Aratana building upon these findings to further develop and seek regulatory approval for additional Lm Technology antigen-targeted constructs for use in veterinary medicine."

About Canine Osteosarcoma

Osteosarcoma is the most common primary bone tumor in dogs, accounting for roughly 85 percent of tumors on the canine skeleton. More than 10,000 dogs a year (predominately middle to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States. This cancer initially presents as lameness and oftentimes visible swelling on the leg. Current standard of care treatment is amputation, when feasible, immediately after diagnosis, followed by chemotherapy. In cases where amputation is not an option, canine patients may receive radiation for palliative care. Invariably, however, the cancer metastasizes to the lungs, eventually leading to death.

On June 8, 2015 Oncolytics Biotech reported an update on its planned registration program for REOLYSIN, its proprietary formulation of the human reovirus, at its Annual General Meeting of Shareholders (Press release, Oncolytics Biotech, JUN 8, 2015, View Source [SID:1234505378]). The presentation highlights that:

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The Company will initially focus on pursuing registration for REOLYSIN in two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma; and
The Company will determine further indications and treatment types in which to pursue registration subject to its receipt of data from ongoing single-arm and randomized studies with REOLYSIN.
"In determining our registration program, we have selected indications and study designs that rely on previous results from our existing preclinical and clinical program and will allow us to move into registration studies immediately after the completion of confirmatory run-in clinical trials," said Dr. Brad Thompson, President and CEO of Oncolytics.

Planned Registration Program for Muscle-Invasive Bladder Cancer

The Company has filed an Investigational New Drug Application ("IND") to conduct a small run-in study in patients with muscle-invasive bladder cancer. Pre-operative patients will be treated with a combination of gemcitabine, cisplatin and REOLYSIN and assessed for histopathological response and safety. Subject to confirmation of histopathological responses attributable to REOLYSIN, the Company intends to conduct a larger registration study in this indication.

Planned Registration Program for Gliomas

The Company recently announced that the IND containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors" was active. The Company intends to conduct a separate small run-in study combining the standard of care (surgery followed by radiotherapy and temozolomide) with REOLYSIN in adult patients. Subject to confirmation of responses, the Company intends to conduct a larger registration study using the better therapeutic regime.

On June 5, 2015 Genmab reported its licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab (Press release, Genmab, JUN 5, 2015, View Source [SID:1234505254]). The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. A rolling submission allows completed portions of the application to be submitted to the FDA on an ongoing basis. The FDA grants this type of review if the agency determines after a preliminary evaluation of clinical data that the breakthrough therapy may be effective and therefore, will consider reviewing portions of an application before the submission is complete. In August 2012, Genmab and Janssen Biotech, Inc. entered an agreement which granted Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. Janssen is currently the sponsor of all but one study globally.

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The submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a proteasome inhibitor and an IMiD or who are double refractory to a proteasome inhibitor and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation (BTD) for this indication from the FDA in May 2013.

"Daratumumab is a highly innovative antibody that holds promise for patients with multiple myeloma, a disease for which there is currently no cure. Today, patients that are double refractory have run out of treatment options and we are very pleased that daratumumab offers the potential to help this group of patients. The initiation of this rolling BLA submission is a landmark in the development of daratumumab and we are working together with Janssen to bring this new treatment option to patients as quickly as we can," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.

(Filing, 10-Q, Generex, JUN 5, 2015, View Source [SID:1234505371])

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