On June 29, 2015 Eli Lilly and Immunocore reported that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore’s lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly’s galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma (Press release, Eli Lilly, JUN 29, 2015, View Source [SID:1234506000]). The goal of the collaboration is to identify combination regimens that provide synergies in efficacy and durability in patients with metastatic cutaneous and uveal melanomas. Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, Immunocore and Lilly will conduct a Phase Ib/II clinical study evaluating the safety and preliminary efficacy of IMCgp100 in combination with galunisertib in metastatic cutaneous melanoma. A second Phase Ib/II study will be conducted combining IMCgp100 with merestinib in metastatic uveal melanoma. Lilly will act as trial sponsor. These studies are anticipated to begin in 2016. No financial terms were disclosed. Know more, wherever you are: IMCgp100 and galunisertib are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body’s own immune system in fighting cancer and whose mechanisms of action have the potential to be complementary. IMCgp100 is Immunocore’s most advanced Immune mobilizing mTCR Against Cancer molecules (ImmTAC), which are a novel class of bi-specific biologic drugs based on T cell receptors (TCRs) with ultra-high affinity for intracellular and extracellular cancer targets. Lilly’s galunisertib is a small molecule inhibitor of TGF beta R1 kinase that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. Merestinib is Lilly’s small molecule multi-kinase inhibitor that in vitro selectively blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2, pathways that potentially play a role in metastatic uveal melanoma. Know more, wherever you are: "This collaboration with Immunocore underscores Lilly’s commitment to discovering the potential of combination therapies, which will be key to the future of cancer care for people fighting diseases such as melanoma," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "Lilly is building a robust portfolio of potential advances in immunotherapy through our own research as well as with strategic collaborations like Immunocore."
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Immunocore and Lilly entered into a co-discovery and co-development collaboration, announced in July 2014, to research and potentially develop other novel T cell-based cancer therapies built on Immunocore’s ImmTAC platform.
"We are very pleased to be able to announce a second collaboration with Lilly after entering into a collaboration last year," said Eliot Forster, chief executive officer of Immunocore. "Combining our ImmTAC, IMCgp100 with Lilly’s galunisertib and merestinib has the potential to transform the treatment of metastatic cutaneous and uveal melanoma. Immunocore is committed to the development of IMCgp100 in metastatic uveal and cutaneous melanoma where there is such great unmet medical need."
Immunocore recently announced clinical efficacy data in a Phase I/IIa trial with IMCgp100 in patients with advanced melanoma, as well as in the expansion cohort with uveal melanoma.
About Melanoma
Melanoma is a cancer that begins in the melanocytes. Other names for this cancer include malignant melanoma and cutaneous melanoma. Most melanoma cells still make melanin, so melanoma tumors are usually brown or black. But some melanomas do not make melanin and can appear pink, tan, or even white.
Melanomas can develop anywhere on the skin, but they are more likely to start on the trunk (chest and back) in men and on the legs in women. The neck and face are other common sites.
Melanoma is much less common than basal cell and squamous cell skin cancers, but it is far more dangerous. Like basal cell and squamous cell cancers, melanoma is almost always curable in its early stages. But it is much more likely than basal or squamous cell cancer to spread to other parts of the body if not caught early.[i]
According to the American Cancer Society’s estimates for melanoma in the United States for 2015, about 73,870 new melanomas will be diagnosed (about 42,670 in men and 31,200 in women); and about 9,940 people are expected to die of melanoma (about 6,640 men and 3,300 women).[ii]
Uveal (or ocular) melanoma is a cancer of the eye diagnosed in approximately 2,000-2,500 adults annually in the United States. In both the U.S. and Europe, this equates to about 5-7.5 cases per million people per year and, for people over 50 years old, the incidence rate increases to around 21 per million per year.[iii]
About IMCgp100 and ImmTACs
Immunocore’s proprietary technology is focused on small protein molecules called ImmTACs (Immune mobilizing mTCR Against Cancer) that enable the immune system to recognize and kill cancerous cells.
Immunocore’s ImmTACs, a new class of drug with ultra-high affinity for intracellular cancer targets, are synthetic, soluble T cell receptors (TCRs) that recognize diseased cells containing disease specific targets. The ImmTACs enable circulating T cells to selectively identify and kill diseased cells. The ImmTAC platform is unique and has very high specificity and potency as well as broad applicability to a wide range of intracellular targets. ImmTACs can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies.
TCRs naturally recognize diseased cells and Immunocore’s world-leading competitive advantage is its ability to engineer high affinity TCRs and link them to an antibody fragment that activates a highly potent and specific T cell response to recognize and destroy cancer cells.
The most advanced ImmTAC, IMCgp100, is currently in Phase IIa clinical trials for the treatment of late stage melanoma. Following completion of a Phase I study at the end of 2013, Immunocore initiated a Phase IIa study to optimize the dosing regimen of IMCgp100. Immunocore has a growing internal pipeline of ImmTACs addressing many different cancer types and has developed a broad database of intracellular cancer targets.
About Galunisertib (LY2157299)
Galunisertib is a TGF beta R1 kinase inhibitor that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body.
About Merestinib (LY2801653)
Merestinib is Lilly’s multi-kinase inhibitor that in vitro selectively blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2.
Author: [email protected]
The Leukemia & Lymphoma Society Accelerates Milestone Payment Associated with the Phase 3 Study of CPX-351 in High Risk (Secondary) AML
On June 29, 2015 Celator Pharmaceuticals reported that The Leukemia & Lymphoma Society (LLS) is accelerating a portion of the final payment linked to the Phase 3 study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator’s lead product candidate, for the treatment of patients with high-risk (secondary) acute myeloid leukemia (AML) (Press release, Celator Pharmaceuticals, JUN 29, 2015, View Source [SID:1234505999]). Schedule your 30 min Free 1stOncology Demo! LLS has moved forward payment of $400,000 originally attached to the final overall survival analysis milestone and added it to the milestone payment for induction response rate analysis, thereby increasing the payment from the original amount of $500,000 to $900,000. This brings the total LLS funding paid to date associated with the Phase 3 study to $4.9 million.
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The financial support provided by the LLS Therapy Acceleration Program (TAP) has been important in expediting the completion of the Phase 3, multicenter trial of CPX-351 versus conventional cytarabine plus daunorubicin in older patients with untreated high risk (secondary) AML. Enrollment in the study was completed ahead of schedule, and positive induction response results were announced earlier this month. The overall survival results, the primary endpoint of the study, are expected in the first quarter of 2016. This study is planned to support a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) expected in the second half of 2016.
"We continue to be very pleased with the progress and positive outcomes Celator has achieved with the development of CPX-351," said Louis DeGennaro, Ph.D., LLS’s chief executive officer. "We felt it appropriate to accelerate our payments to assist Celator in completing the activities necessary to file the NDA with the FDA as soon as possible once the overall survival data become available. We are optimistic for a successful outcome of the Phase 3 study and want to help accelerate the availability of promising therapies such as CPX-351 to these patients who are in dire need of improved outcomes."
As part of a 2009 partnership, LLS provided $4.1 million to help fund Celator’s Phase 2 clinical development program, which included two randomized, controlled studies. The positive results from those two studies were used to help design the current Phase 3 study. LLS’s TAP program supports private sector and academic-based projects with the goal of advancing investigational therapies with high prospects for providing near-term benefit to patients with blood cancers.
"This additional funding comes at an opportune time," said Scott Jackson, Celator’s chief executive officer. "With the recent announcement of positive induction response rate results for our Phase 3 study, we continue to move forward with our preparations for an NDA filing and ultimately commercialization of CPX-351 in the United States. These activities will benefit from the earlier availability of TAP funds and with positive overall survival results in our Phase 3 study, CPX-351 will be available to AML patients as soon as possible. Our partnership with LLS, which began back in 2008, has been extremely productive towards that end."
About CPX-351
CPX-351 (cytarabine:daunorubicin) Liposome for Injection represents an innovative approach to developing combinations of drugs, in which drug molar ratios with synergistic anti-tumor activity are co-encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food and Drug Administration and the European Commission for the treatment of Acute Myeloid Leukemia (AML). Celator has conducted two randomized, controlled, Phase 2 studies with CPX-351. The first study was conducted in newly diagnosed elderly AML patients and the second study was conducted in patients with AML in first relapse. In both Phase 2 studies, treatment with CPX-351 resulted in significant improvements in response rates, 60-day mortality, and overall survival in the highest risk patients. The Leukemia & Lymphoma Society has partnered with Celator in the development of CPX-351 starting in Phase 2 and continuing in Phase 3.
About Acute Myeloid Leukemia (AML)
LLS defines AML as a quickly progressing disease in which too many immature white blood cells (not lymphocytes) are found in the blood and bone marrow. According to Cancer Facts and Figures, in 2015 approximately 20,830 new cases of AML will be diagnosed in the United States and 10,460 deaths will occur from the disease.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
4SC’s partner Yakult Honsha enters with cancer compound resminostat further
indications and starts clinical Phase I study in patients with pancreatic or
biliary tract cancer in Japan
On June 26, 2015 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, reported that the first patient has been treated with resminostat in a Japan-based Phase I clinical study conducted by 4SC’s exclusive Japanese partner Yakult Honsha (Press release, 4SC, JUN 26, 2015, View Source [SID:1234506545]). The multi-centre open-label study will investigate safety, pharmacokinetics, biomarkers and efficacy of various dose regimens of resminostat in monotherapy or in combination with the S-1 chemotherapy in up to 44 Japanese patients with advanced pancreatic or biliary tract cancer. The main goal of the study is to determine the recommended regimen for subsequent Phase II trials in these indications.
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In Part 1 of the study, dose limiting toxicities (DLTs) of various dose regimens of resminostat in monotherapy and the resminostat/S-1 combination therapy will be determined in up to 24 patients. In Part 2, the tolerability and safety of the regimen/s selected in Part 1 will be further evaluated in 20 additional patients in order to determine the recommended regimen/s for subsequent Phase II studies. Furthermore, the study will investigate pharmacokinetics, biomarkers and efficacy criteria including best overall response, progression-free survival (PFS), and overall survival (OS).
The overall development rationale behind the study is to test the epigenetic agent resminostat in further gastrointestinal indications and in particular in combination with the S-1 chemotherapy, which is approved for the treatment of pancreatic and biliary tract cancer in Japan. S-1 contains a prodrug of the chemotherapeutic agent 5-FU. Resminostat has already been tested clinically in a Phase I study in combination with the 5-FU-based FOLFIRI chemotherapy regimen in Western patients with colorectal cancer. The administration of resminostat in combination with the standard FOLFIRI regimen was well tolerated without any dose limiting toxicity. Moreover in preclinical models, resminostat has shown first positive results in pancreatic and biliary tract cancer. 2
Enno Spillner, Chief Executive Officer of 4SC AG, said: "We very much appreciate that our partner Yakult Honsha has started developing resminostat in combination therapy with an established cancer drug in additional two gastrointestinal solid cancer indications in Japan. There is high unmet medical need in both pancreatic and biliary tract cancer. These new indications are a perfect match to the ongoing Phase II trials by Yakult investigating resminostat in combination therapies in the indications liver cancer (HCC) and non-small-cell lung cancer (NSCLC). While Yakult is evaluating resminostat in a number of mostly gastrointestinal solid cancer indications in Asian patients, 4SC intends to focus, as the immediate next step, on developing resminostat in the heamatological indication of CTCL in Europe where we also see a high medical need and an attractive opportunity for a fast-tomarket option for resminostat. We are currently preparing a European Phase II study in CTCL."
About pancreatic cancer and biliary tract cancer
Pancreatic cancer is characterized as a disease with some of the highest unmet need in oncology. is The disease is responsible for 331,000 deaths per year, and is thus the seventh most common cause cancer-related mortality in both sexes combined. Patients with pancreatic cancer have a poor prognosis with a median survival of 4-6 months and a five-year survival rate of below 5%, representing one of the poorest prognoses across gastrointestinal (GI) cancers. Approved drugs for first line setting in Western countries comprise the chemotherapies gemcitabine and FOLFIRINOX. In Japan, S-1 has been approved for the treatment of pancreatic cancer since 2006.
Primary bile duct cancer is a relatively rare cancer, however, with the number of new cases increasing. In Japan, the incidence of biliary tract cancer and intrahepatic bile duct cancer is about 10 out of every 100,000 people, which is higher than the incidences in other countries. These cancers typically have a poor prognosis, with 5-year survival rates in the range of 5% to 15%. In Japan, chemotherapies gemcitabine, cisplatin and S-1 have been used in this indication.
About resminostat
Resminostat (4SC-201) is an oral protein-deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, both in monotherapy and, in particular, in combination with other cancer drugs. Like other epigenetic therapies, resminostat modifies transcription of genes in cancer cells and, thereby, reprograms the phenotypes of such cancer cells. Additionally, resminostat has immunotherapeutic effects by activating NK cells, restoring MHCI and MHCII proteins and suppression of unspecific immunosuppression. Resminostat is assumed to be able to halt tumour progression and induce tumour regression. Furthermore, due to its epigenetic 3 mode of action resminostat is supposed to develop additional synergetic effects when combined with classical cancer therapies and to counteract the development of tumour cell resistance. For example, in preclinical trials, resminostat has been shown to effectively inhibit epithelial-mesenchymal transition (EMT). EMT, which may be promoted through the administration of certain conventional cancer therapies, leads to the formation of particularly aggressive tumour cells, which ultimately may result in greater proliferation of cancer cells in patients and the patients’ death. On the whole, a reinforcing positive therapeutic effect is expected to be achieved through a well-tolerated combination of a traditional cancer therapy with an epigenetic compound such as resminostat.
Resminostat – by 4SC and its Japanese partner Yakult – has been investigated in a broad clinical campaign comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin’s Lymphoma (HL), colorectal cancer (CRC), and non-small-cell lung cancer (NSCLC). In the Phase II SAPHIRE trial in patients with advanced Hodgkin’s Lymphoma (HL), resminostat monotherapy has demonstrated antitumour activity, with an overall response rate of 34% and a clinical benefit in 54% of the patients in a heavily pre-treated patient population together with very good safety and tolerability. In the Phase IIa SHELTER study resminostat has been evaluated as monotherapy and in combination with sorafenib as a second-line treatment in advanced Western HCC patients after proven radiological disease progression under first-line sorafenib therapy. Patients receiving the resminostat/sorafenib combination therapy showed a median overall survival of 8.0 months and a progression-free survival rate (PFSR) after 12 weeks of 62.5% and a median time-to-progression (TTP) of 6.5 months. Notably, in both tumour indications, HCC and HL, gene expression levels of the new biomarker ZFP64 measured prior to study treatment start in blood cells of patients, were identified to be potentially indicative of survival outcome upon treatment with resminostat. Hereby, the set of patients with a high level of ZFP64 gene expression at baseline showed a statistically significant increase of median overall survival compared with patients with low ZFP64 expression levels. Resminostat was further studied in a Phase I dose escalation approach in advanced colorectal cancer (CRC) patients evaluating resminostat in combination with the standard chemotherapeutic FOLFIRI regimen. Positive results for safety and tolerability as well as promising signs of clinical activity of this combination were published at the 2013 ASCO (Free ASCO Whitepaper) conference. Yakult Honsha is currently developing resminiostat in two randomised clinical Phase II trials in Asian patients in HCC and NSCLC and in a Phase I trial in patients with pancreatic and biliary tract cancer. Resminostat is partnered with Yakult Honsha for Japan and with Menarini in the Asia Pacific (APAC) region excluding Japan. 4SC is currently in preparations of a randomised, controlled Phase II trial in the indication of advanced cutaneous T-cell lymphoma (CTCL) in Europe.
About the resminostat partnering agreement with Yakult Honsha for Japan
4SC granted an exclusive license to Yakult Honsha for the development and commercialization of resminostat in Japan in April 2011. 4SC has received an upfront payment from Yakult Honsha of €6 million and is eligible for up to approximately €127 million payable upon achieving specified milestones 4 including clinical and regulatory events in Japan. In addition to milestone payments, Yakult will pay 4SC double-digit royalties linked to product sales of resminostat. Yakult Honsha will be responsible for all clinical requirements for resminostat development in Japan in oncology indications. 4SC is aiming to partner this compound in other territories, including Europe and the USA.
OPKO 4Kscore® Recommended in National Comprehensive Cancer Network Guidelines for Prostate Cancer Early Detection
On June 26, 2015 OPKO Health, Inc. (NYSE:OPK) reported the decision of the National Comprehensive Cancer Network (NCCN) to include 4Kscore as a recommended test in the 2015 NCCN Guidelines for Prostate Cancer Early Detection (Press release, Opko Health, JUN 26, 2015, View Source [SID:1234506544]). The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.
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"We are pleased that the NCCN, an organization leading the way in the establishment of evidence-based guidelines for cancer diagnostics, is recommending the use of the 4Kscore test in the 2015 Prostate Cancer Early Detection Guidelines," said David Okrongly, Ph.D., President of OPKO Diagnostics.
The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. "Since its launch, I have been offering and using the 4Kscore test with my patients who have an abnormal PSA prior to a first prostate biopsy and before repeating a prostate biopsy after a negative biopsy," said Dr. Dipen Parekh, Professor and Chair, Department of Urology at the University of Miami and principal investigator for the recently published United States multicenter validation study. "The 4Kscore provides me as a clinician with important information about my patient’s individual risk for having aggressive prostate cancer and allows me to have an informed discussion with my patient about whether or not to proceed with a prostate biopsy or safely follow the patient."
The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer. In arriving at their recommendations, the NCCN panel stated: "The challenge is to minimize immediate treatment (over-treatment) of indolent cancers by accurately characterizing the biology of the detected cancer. Identification and selective treatment of aggressive cancers should result in significant decreases in morbidity and mortality while limiting adverse effects on quality of life."
"OPKO is committed to the strategy that effective therapy, particularly cancer therapy, can be greatly enhanced by use of diagnostic tests," said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. "Through diagnostics, we can enable physicians to take a more targeted and precise approach in their treatment strategies and thus improve patient outcomes and lower overall healthcare costs."
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient’s age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions and is established as a recommended standard of care in the 2015 NCCN Prostate Cancer Early Detection Guidelines. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between the Urologist and the patient.
Provectus Biopharmaceuticals’ Data on PV-10 as Treatment for Melanoma Presented at 5th European Post-Chicago Melanoma / Skin Cancer Meeting
On June 26, 2015 Provectus Biopharmaceuticals reported that Dr. Vernon Sondak (Moffitt Cancer Center, Tampa, FL, USA) presented data on "Intralesional Therapy for Melanoma with PV-10" during the 5th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany (Press release, Provectus Pharmaceuticals, JUN 26, 2015, http://www.pvct.com/pressrelease.html?article=20150626.1 [SID:1234505810]).
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Dr. Sondak spoke during "Symposium III – New Drugs and Trials I: Immunotherapy," held Thursday, June 25. His conclusions included that "among the many agents currently being evaluated for use as intralesional therapy for melanoma, PV-10 possesses favorable safety and handling properties and induces rapid ablation of injected lesions to a degree similar to or possibly better than other agents," and "preclinical and clinical data suggest PV-10 would be a good candidate to evaluate in conjunction with available systemic immunotherapies."
The complete presentation is available at http://www.pvct.com/publications/Post-Chicago-Munich-Sondak-2015.pdf.
In addition, the poster titled "Trials in Progress: Intralesional Rose Bengal vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma," which details the Company’s phase 3 clinical trial that began recently, was also presented at the meeting. For the poster, visit http://pvct.com/publications/Post-Chicago-Munich-2015.pdf.