On May 18, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) reported that preclinical and clinical data on cerdulatinib in relapsed/refractory b-cell malignancies will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper), which is taking place from June 22-25 in Madrid, Spain (Press release, Portola Pharmaceuticals, MAY 18, 2017, View Source [SID1234519238]).

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Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor in development to treat patients with resistant or relapsed hematologic cancers. Cerdulatinib inhibits two key signaling pathways that promote cancer cell growth in certain hematologic malignancies.

Details regarding the presentations follow.

Oral Presentation Details:

Presentation Title: The Dual SYK/JAK Inhibitor Cerdulatinib Demonstrates Complete Inhibition of SYK and JAK and Rapid Tumor Responses in a Phase 2 Study in Patients with Relapsed/Refractory B Cell Malignancies
Presenter: Paul Hamlin, M.D., Memorial Sloan-Kettering Cancer Center
Abstract Number: EHA (Free EHA Whitepaper)22
Presentation Date and Time: June 25, 2017 from 9:00-9:15 a.m. UTC
Location: Hall A
Poster Presentation Details:

Presentation Title: IL-4 Increases Expression of Positive Regulators of BCR Signaling in CLL Which Can Be Overcome by Cerdulatinib
Presenter: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton
Abstract Number: P587
Presentation Date and Time: June 24, 2017 from 5:30 – 6:00 p.m. UTC
Location: Poster Hall (Hall 7)

On May 18, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending March 31, 2017, the third quarter of the Company’s 2017 fiscal year (Press release, DelMar Pharmaceuticals, MAY 18, 2017, View Source [SID1234519234]). DelMar’s executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday May 24th, 2017 at 4:30 p.m. Eastern Standard Time.

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RECENT CORPORATE HIGHLIGHTS

Completed public offering of common stock and warrants for gross proceeds of $9.0 million
Continued to advance the development of VAL-083 as a potential new treatment for Glioblastoma Multiforme ("GBM")
Expanded research collaborations with leading academic institutions
Presented promising research results supporting the potential of VAL-083 in the treatment of other cancers at leading scientific conferences
"Our recent financing enables us to remain on-track to initiate the pivotal Phase 3 clinical trial of VAL-083 in refractory GBM. This milestone, combined with VAL-083’s recent scientific advancements form the foundation for this molecule to serve as a platform asset addressing unmet medical needs in a broad range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors both as a single agent and as a key component of combination therapy regimens," stated Jeffrey Bacha DelMar’s chairman & CEO.

In April, the Company announced the closing of a $9 million offering of common stock and warrants which was led by leading healthcare dedicated institutional investors.

During the quarter, the Company made key advancements for VAL-03 as a treatment for GBM patients whose tumors express features, such as high expression of the enzyme MGMT, that make their cancer resistant to, or unlikely to, respond to currently available therapy. Accomplishments achieved included submitting a protocol to the FDA for a pivotal, controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy for GBM patients who have previously failed both temozolomide (Temodar) and bevacizumab (Avastin). The Company also announced a collaboration with PRA Health Sciences ("PRA") as the contract research organization to oversee and manage the Company’s pivotal VAL-083 STAR-3 GBM clinical trial. PRA Health Sciences is one of the world’s leading global contract research organizations, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 13,000 employees worldwide.

During the period, the Company also continued enrolling its Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin) exposure in collaboration with the University of Texas MD Anderson Cancer Center ("MD Anderson"). Additionally, DelMar received ethics committee approval, retained a contract research organization, and submitted an application to the China Office of Human Genetic Resources Authority ("OHGRA") to allow for initiation of the Company’s planned Phase 2 clinical trial in newly diagnosed patients with MGMT-unmethylated GBM at Sun Yat Sen University in Guangzhou, China. DelMar also entered into a sponsored research agreement with Duke University to evaluate VAL-083 as a front-line treatment for newly diagnosed patients with GBM.

DelMar also continued to present promising research results supporting the potential of VAL-083 in the treatment of a range of cancers, including GBM, at leading scientific conferences. The Company presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers at the 11th Biennial Ovarian Cancer Research Symposium. Additionally, data was presented indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship. In April, new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s ("AACR") annual meeting. And in May, the Company presented new research at the 5th Quadrennial Meeting of the World Federation of Neuro-Oncology Societies demonstrating that VAL-083 circumvents both of the primary mechanisms correlated to chemoresistance to temozolomide, the current standard of care in the treatment of GBM.

"GBM represents one of the few cancers that has been largely left behind in the tremendous medical advancements of modern cancer care. Success in our GBM clinical trials will provide VAL-083 as a new treatment for patients who currently have no viable therapeutic option," said Mr. Bacha. "Our research with VAL-083 also seeks to expand this opportunity beyond GBM to a wide range of solid tumor patients whose cancer is resistant or unlikely to respond to currently available treatments. Unlocking the value of VAL-083 for our patients and our shareholders is our primary goal."

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss quarterly results and provide a corporate update on Wednesday, May 24th, 2017, at 4:30 p.m. Eastern Standard Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 800‑894‑5910 (toll free) with Conference ID DELMAR.

Listeners can also attend the call via webcast https://engage.vevent.com/rt/delmar_ao~051817. A link to the webcast and slides will be archived on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be available for 30 days following the webcast.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED MARCH 31, 2017; THIRD QUARTER OF FISCAL YEAR 2017

For the three months ended March 31, 2017 the Company reported a net loss of $1,868,460 or $0.18 per share, compared to a net loss of $1,140,401, or $0.10 per share for the three months ended March 31, 2016.

For the nine months ended March 31, 2017 the Company reported a net loss of $5,480,772 or $0.54 per share, compared to a net loss of $5,408,479, or $0.50 per share for the nine months ended March 31, 2016.

Our quarterly expenditures during the current fiscal year to date have been consistent and reflect increased activities being undertaken in preparation for initiation of our planned pivotal Phase 3 clinical trial.

The following represents selected financial information as of March 31, 2017. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis ("MD&A"), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Selected Balance Sheet Data


March 31,
2017
$

June 30,
2016
$
Cash and cash equivalents


2,100,406



6,157,264

Working capital


1,454,384



5,692,336

Total assets


2,340,891



6,355,799

Derivative liability


248,690



693,700

Total stockholders’ equity


1,230,137



4,858,778



Selected Statement of Operations Data
For the Three Months Ended:









March 31,


March 31,



2017


2016



$


$

Research and development


1,086,107



790,323

General and administrative


698,125



630,226

Change in fair value of stock option and derivative liabilities


77,479



(276,584)

Change in fair value of derivative liability due to change in warrant terms


–



7,000

Foreign exchange loss (gain)


6,897



(10,523)

Interest income


(148)



(41)

Net and comprehensive loss for the period


1,868,460



1,140,401

Series B preferred stock dividend


209,811



–

Net and comprehensive loss available to common stockholders


2,078,271



1,140,401

Basic weighted average number of shares outstanding


11,574,052



11,077,275

Basic and fully diluted loss per share


0.18



0.10

Excluding the impact of non-cash expense, research and development expenses increased to $968,332 during the three months ended March 31, 2017 from $660,857 for the three months ended March 31, 2016. The difference was largely attributable to an increase in clinical research and intellectual property costs. Clinical research costs have increased due to protocol development and manufacturing activities conducted in preparation for our pending pivotal Phase 3 clinical trial in refractory GBM, our two Phase 2 clinical trials in MGMT-unmethylated GBM as well as an expansion of our preclinical and other research activities compared to the prior period.

Excluding the impact of non-cash expenses, general and administrative expenses increased in the three months ended March 31, 2017 to $635,769 from $517,030 for the three months ended March 31, 2016. The increase was largely attributable to activities undertaken in preparation for our recent financing.

We estimate that our current working capital, including proceeds from our recent financing is sufficient to support our planned operations for the next 18-24 months.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

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.

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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.

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.

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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.

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.

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]).

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Details on the presentation is as follows:


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.