On May 18, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), (the "company"), an oncology-focused, clinical stage biotechnology company, today announces preclinical data from three abstracts demonstrating the utility of the company’s lead compound, CLR 131, for use in a variety of tumor types in single-dose and multi-dose regimens (Press release, Cellectar Biosciences, MAY 18, 2017, View Source [SID1234519233]). The abstracts were published as part of the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings. Schedule your 30 min Free 1stOncology Demo!
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"These peer-reviewed studies, while early stage, further demonstrate the variety of potential applications and dosing regimens for CLR 131. In these preclinical models, we have observed measurable reduction compared to a control in tumor growth of three different cancer types while also showing a clear survival benefit," said Jim Caruso, president and CEO of Cellectar Biosciences. "While CLR 131 is currently in Phase 1 and Phase 2 trials for blood cancers, the publication of these abstracts indicate promise in solid tumors, and provide further data on the potential benefit of a multi-dose regimen."
In the first study, 20 mice were injected with glioma (brain) tumor cells (U87-MG). Investigators then injected two doses of CLR 131 (95.7µCi and 109.0 µCi on day 0 and day 7, respectively) or a control group of I-127-CLR 1404 (N=8 per group). The expected 25-fold increase in tumor burden observed in the control arm over the four-week study was reduced by 50 percent in the CLR 131 arm with additional survival benefit. In fact, the two doses of CLR 131 provided a 50 percent increase in survival over a single dose of CLR 131 in the same model.
The second study involved female mice receiving two doses of CLR 131 (approximately 130 µCi and approximately 145 µCi at days 0 and 20, respectively) as well as a control group of I-127-CLR 1404 (N=8 per group), following injection of female mice with a MES SA/Dx5 cell line (human uterine sarcoma). This model was selected because of its high level of expression of resistance mechanisms these tumor cells exhibit, specifically P-gp efflux pumps that eject many chemotherapeutics from the cell. The active treatment group (CLR 131) experienced a 66 percent reduction of the expected 21-fold increase in tumor burden observed in the control group. This resulted in nearly doubling the survival time for the mice receiving two doses of CLR 131.
The final study entailed the injection of mice with Caki-2 cell line (human clear cell carcinoma, common in renal cancer). Once tumor size reached a pre-determined volume, these mice received either a single dose of CLR 131 (approximately 110µCi), or a control of I-127-CLR 1404 (N=8 per group). The control group showed exponential growth at 20 days post-injection, while the treatment group experienced a reduction in the initial tumor volume through day 65 post-injection and had the same initial tumor volume at day 75 post-injection. By day 65, the control group increased 10.75-fold compared to the treatment group in average tumor volume.
About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase 1 clinical trial in patients with relapsed or refractory (R/R) multiple myeloma (MM) as well as in a Phase 2 clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment. Based upon preclinical and interim Phase 1 study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall survival, an improvement in progression-free survival, surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.
About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.
OPKO Health’s 4Kscore® Test Highlighted in Podium Presentation at 112th American Urological Association Annual Meeting
On May 18, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ:OPK), reported that data from a prospective study conducted at Veteran Affairs (VA) hospitals confirming the 4Kscore test’s ability to accurately predict aggressive prostate cancer were presented in a podium presentation on May 16, 2017 at the 112th American Urological Association (AUA) Annual Meeting in Boston. Schedule your 30 min Free 1stOncology Demo! The study entitled, "An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer," was presented by Sanoj Punnen, M.D., Assistant Professor of Urologic Oncology at the Miller School of Medicine, Department of Urology at the University of Miami in Miami, Florida. The study is the second U.S. prospective clinical study to establish the clinical validity of the 4Kscore test to predict the presence of aggressive prostate cancer prior to performing a prostate biopsy.
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The VA study was conducted at eight VA hospitals across the United States. A total of 366 men were enrolled in the study, and 208 (56%) of the participants were African American. Of all cancers diagnosed among African American men, prostate cancer is the most common (31% of all cancers), and African American men have a twofold greater risk of prostate cancer mortality compared to non-Hispanic whites.1
Overall, the 4Kscore demonstrated a high degree of accuracy for predicting the presence of aggressive (Gleason score 7 and higher) prostate cancer with an area under the receiver operator curve (AUC) of 0.81, significantly better than PSA alone or a clinical model based on PSA. Importantly, there was an equally high ability of the 4Kscore to discern aggressive disease in the African American men compared with the non-African American men (AUC = 0.80 v. 0.84, p = 0.32). The calibration and decision curve analysis were also consistent with the performance shown in the first U.S. validation study.
"The VA study confirms the 4Kscore’s accuracy in predicting a man’s risk of having aggressive prostate cancer and showed that it is an equally effective and vital clinical test for African American men, who have the highest rates of prostate cancer mortality," said Phillip Frost, M.D., Chairman and CEO of OPKO Health. "These positive results add to our growing body of clinical evidence that demonstrate 4Kscore’s utility to accurately identify the risk of aggressive prostate cancer. Moreover, these data validate the clinical value of the 4Kscore test in a VA setting and show it to be identical to the performance previously shown in community and academic sites across the U.S. and Europe."
About Prostate Cancer
According to the Prostate Cancer Foundation,2 "every 3.3 minutes a man is diagnosed with prostate cancer, and millions of men and their families are fighting the disease globally. In the United States, prostate cancer affects 1 in 8 men, making it the most common non-skin cancer in America. This means that a non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma, and kidney cancers combined. In 2017 alone, it is estimated that more than 161,000 men will be diagnosed with prostate cancer, and more than 27,000 will die from the disease. A man of African descent is 73% more likely to develop prostate cancer than a Caucasian man, and more than twice as likely to die from the disease."
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient’s age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher 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. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines.
Stemline Therapeutics to Present SL-401 Updated Data from Stage 1 and 2 of Ongoing Pivotal Phase 2 BPDCN Trial at Upcoming European Hematology Association (EHA) Meeting
On May 18, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, reported that SL-401 Stage 1 and 2 data from its ongoing pivotal Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been accepted for poster presentation at the 2017 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, to be held June 22-25, 2017 in Madrid, Spain (Press release, Stemline Therapeutics, MAY 18, 2017, View Source [SID1234519227]). Schedule your 30 min Free 1stOncology Demo! Details on the presentation is as follows:
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SL-401 – BPDCN Presentation
Title: Ongoing Phase 2 Clinical Trial Of SL-401 In Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Stage 1 And Stage 2 Results
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: P191
Session: Acute myeloid leukemia – Clinical 1
Date/Time: Friday, June 23 – 5:15-6:45 PM CET
Location: Hall 7 – Poster Area
Stemline remains on track to provide an update on BPDCN patients enrolled in Stage 3 of the Phase 2 pivotal trial in the second half of this year.
Karyopharm’s Phase 2b SADAL Data Evaluating Selinexor in Diffuse Large B-Cell Lymphoma Selected for Oral Presentation at the 2017 European Hematology Association Annual Meeting
On May 18, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that interim clinical data from the ongoing Phase 2b SADAL study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be featured in an oral presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain (Press release, Karyopharm, MAY 18, 2017, View Source [SID1234519226]). Schedule your 30 min Free 1stOncology Demo! "DLBCL is the most common type of non-Hodgkin lymphoma among adults and there remains a high unmet medical need, particularly in the relapsed and refractory setting for patients who are not eligible for stem cell transplant or who relapse afterward," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Previously reported data from the ongoing Phase 2b SADAL study showed that treatment with single-agent oral selinexor resulted in robust response rates with prolonged durability in patients with heavily pretreated DLBCL, including against both GCB and non-GCB (ABC) subtypes. We look forward to sharing some further detail from the SADAL study with the medical community at EHA (Free EHA Whitepaper) and ICML this year."
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In addition, Karyopharm’s Phase 2b SADAL data were also selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland.
Details for the Oral Presentation at EHA (Free EHA Whitepaper) 2017:
Title: Single Agent Oral Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study
Presenter: Marie Maerevoet, Institute Jules Bordet, Brussels, Belgium
Abstract code: S469
Topic: Aggressive Non-Hodgkin lymphoma — Clinical
Session: Aggressive Non-Hodgkin lymphoma — Relapsed/refractory
Location: Hall C
Date and Time: Saturday, June 24, 2017 from 14:45 – 17:00 CET
Details for the Poster Presentation at ICML 2017:
Title: A Phase 2b Randomized Study of Single Agent Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Presenter: Rene-Olivier Casanovas, Hematologie Clinique, CHU Dijon, France
Poster #: 193
Location: Marquee Parco Ciani
Date and Time: From Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in May 2017. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.
Onconova Therapeutics to Present a Poster Session Relating to Intravenous Rigosertib at the 2017 American Society of Clinical Oncology Annual Meeting
On May 18, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported details relating to a poster presentation addressing Intravenous Rigosertib in Second-line Higher Risk MDS at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2nd-6th in Chicago (Press release, Onconova, MAY 18, 2017, View Source [SID1234519224]). Schedule your 30 min Free 1stOncology Demo! Further Rationale for Rigosertib in a Second-line HR-MDS Setting
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Abstract Number: 7056
Title: Relationship of Bone Marrow Blast (BMBL) response to Overall Survival (OS) in a Multicenter study of Rigosertib (Rigo) in Patients with Myelodysplastic Syndromes (MDS) with Excess Blasts Progressing on or After Treatment with a Hypomethylating Agent (HMA).
Date: Monday, June 5, 2017
Time and Location: 8:00 AM — 11:30 AM, McCormick Place, Hall A
Presenter: Aref Al-Kali, MD, Mayo Clinic – Rochester, Minnesota