On September 4, 2015 Clovis Oncology (NASDAQ:CLVS)reported that rociletinib, the company’s oral targeted covalent (irreversible) mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated, T790M positive non-small cell lung cancer (NSCLC), is the subject of four mini-oral presentations and two poster sessions at the 16th World Conference on Lung Cancer (Press release, Clovis Oncology, SEP 4, 2015, View Source;p=RssLanding&cat=news&id=2085448 [SID:1234507399]). Hosted by the International Association for the Study of Lung Cancer (IASLC), the conference will take place September 6-9, 2015 in Denver.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to sharing updated data from the pivotal TIGER-X trial, analyzing the clinical activity of rociletinib in multiple subsets of patients with advanced EGFR mutant NSCLC, specifically in those with a history of CNS metastases, as well as in patients with T790M negative disease," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The coming months are shaping up to be a very busy and important time for rociletinib, as we move forward with our pivotal TIGER clinical trial program and prepare for potential product launches in both the United States and Europe."

Mini-Oral Presentations

Rociletinib in NSCLC patients with negative central testing for T790M in TIGER-X (Abstract #951/MINI03.10)

Heather Wakelee, MD, Stanford University Medical Center
Monday, Sept. 7, 4:45-6:15pm MT
Location: Four Seasons Ballroom F1 + F2
Identification of effective drug combinations to prevent or delay resistance to the EGFR mutant selective inhibitor rociletinib (CO-1686) (Abstract #3010/MINI09.04)

Andrew D. Simmons, PhD, Clovis Oncology
Monday, Sept. 7, 4:45-6:15pm MT
Location: Rooms 205 + 207
Dose optimization of rociletinib for EGFR mutated NSCLC (Abstract #967/MINI16.03)

Jonathan W. Goldman, MD, UCLA Health
Tuesday, Sept. 8, 4:45-6:15pm MT
Location: Four Seasons Ballroom F3 + F4
Activity of rociletinib in EGFR mutant NSCLC patients with a history of CNS involvement (Abstract #965/MINI16.04)

D. Ross Camidge, MD, PhD, University of Colorado Denver
Tuesday, Sept. 8, 4:45-6:15pm MT
Location: Four Seasons Ballroom F3 + F4
Poster Sessions

Poster P1.01-076 – TIGER-1: A randomized, open-label, phase 2/3 study of rociletinib (CO-1686) or erlotinib as first-line treatment for EGFR-mutant non-small cell lung cancer

D. Ross Camidge, MD, PhD, University of Colorado Denver
Monday, Sept. 7, 9:30am-4:45pm MT
Location: Exhibit Hall
Poster P1.01-086 – TIGER-3: A phase 3, open-label, randomized study of rociletinib versus cytotoxic chemotherapy in patients with mutant EGFR non-small cell lung cancer progressing on prior EGFR tyrosine kinase inhibitor therapy and doublet chemotherapy

James Chih-Hsin Yang, National Taiwan University Hospital
Monday, Sept. 7, 9:30am-4:45pm MT
Location: Exhibit Hall
About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

On September 4, 2015 Genmab A/S (OMX: GEN) reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for daratumumab (Press release, Genmab, SEP 4, 2015, View Source [SID:1234507401]). The BLA 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 BLA submission was started by Genmab’s licensing partner, Janssen Biotech, Inc. in June and was completed on July 9, 2015. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA aims to complete its review of the daratumumab BLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

"We are pleased that the FDA has granted Priority Review for daratumumab in double refractory multiple myeloma. If approved, daratumumab has the potential to make a real difference in the lives of people who have run out of other treatment options for multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The BLA 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 PI and an IMiD, or who are double refractory to a PI 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 for this indication from the FDA in May 2013.

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 U.S., after 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 124,225 people will be diagnosed and 87,084 will die from the disease in 2015.4 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 Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.6

About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms7, including complement-dependent cytotoxicity7, antibody-dependent cellular phagocytosis8 and antibody-dependent cellular cytotoxicity7, as well as via induction of apoptosis9 . 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 lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.

On September 4, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the fiscal year ending June 30, 2015 and provided an overview of recent Company highlights and expected near-term milestones (Press release, DelMar Pharmaceuticals, SEP 4, 2015, View Source [SID:1234507397]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RECENT HIGHLIGHTS

VAL-083 (dianhydrogalactitol), for the treatment of refractory glioblastoma multiforme (GBM)

Completed Phase I dose-escalation in the clinical trial in refractory GBM and presented data supporting a dose response trend.
Patients receiving a dose >/= 30mg/m2 had a median survival of nine (9) months vs. five (5) months at doses up to 5mg/m2.
Initiated a Phase II expansion cohort for the GBM study at a dose of 40mg/m2. We anticipate enrolling approximately 14 patients in the Phase II expansion cohort.

To date, 19 patients have been screened and six (6) patients have initiated treatment with VAL-083 at the 40mg/m2 dose.
To further explore the therapeutic window, three (3) patients have also initiated treatment at an interim dose of 45mg/m2. The Phase II expansion cohort may be continued at this higher dose if warranted by safety data.

Continued preparation for advancement into registration-directed Phase II/III clinical trials.

Presented additional data on the activity of VAL-083 against temozolomide-resistant GBM and its potential as a therapeutic option for patients who fail or are unlikely to respond to current front-line therapy.

Added the fourth and fifth Phase I/II clinical trial sites at Mayo Clinic Cancer Center in Rochester, MN and Sarah Cannon Cancer Research Center at HealthOne in Denver, CO.

Expanding our drug development pipeline: Lung and Ovarian Cancer

Non-small cell lung cancer (NSCLC)

Presented preclinical data in lung cancer models supporting differentiation of VAL-083 versus platinum-based chemotherapy in treatment of drug-resistant NSCLC.
Announced plans to initiate clinical research in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group (Co) Ltd.
Ovarian Cancer

Announced the upcoming presentation of new non-clinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer.

Corporate

Raised $2.6 million gross proceeds in a registered direct offering.

Announced an additional non-dilutive funding increase of up to CDN$287,000 from the National Research Council of Canada Industrial Research Assistance Program for continued support of our non-clinical research programs.

Continued to take steps toward listing our common shares on a national stock exchange including reducing the derivative liability component of our balance sheet, appointing new independent directors and establishing required corporate governance structures and policies.

"We have made tremendous progress during this fiscal year in executing our clinical development strategy and driving value into our lead product candidate VAL-083. The promising results of the Phase I dose-escalation study were instrumental in advancing the program in GBM. We anticipate reporting additional data from the Phase II expansion cohort at upcoming peer reviewed scientific meetings and are implementing our plan to advance VAL-083 into a Phase II/III registration-directed clinical program in refractory GBM," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.

"Based on promising results of grant-funded research, we are also preparing to expand the VAL-083 clinical research portfolio into non-small cell lung cancer (NSCLC), which will be funded through our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.," added Mr. Bacha. "We believe our VAL-083 program in NSCLC has significant future potential for partnering opportunities."

Mr. Bacha concluded, "We believe that the unique mechanism of action of VAL-083 provides a basis to address unmet medical needs in a range of cancers."

FY2016 MILESTONES

Complete enrollment of the Phase II expansion study in refractory GBM;
Advance VAL-083 into registration-directed Phase II/III clinical trials;
Expand our clinical development activities through new trials supported by our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd.;
Continue to actively communicate our progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;
Continue to build our intellectual property portfolio; and
Implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.

CONFERENCE CALL DETAILS
The DelMar business update conference call and live webcast is scheduled to begin today at 11:00 a.m. Eastern Time / 8:00 a.m. Pacific 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 (866) 394-9399 (toll-free) with Conference ID 22042321. A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com, and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE FISCAL YEAR ENDED JUNE 30, 2015
For the twelve months ended June 30, 2015 the Company reported a net loss of $4,796,030, or a net loss per share of $0.13, compared to a net income of $3,129,348, or a net income per share of $0.10 for the twelve months ended June 30, 2014. The income from 2014 was due to the revaluation of our derivative liability. During the twelve months ended June 30, 2015 the Company has reduced its derivative liability from approximately $3.3 million at June 30, 2014 to approximately $1.0 million at June 30, 2015 through warrant exercises and exchanges.

The Company ended the 2015 fiscal year with approximately $1.75 million of cash and cash equivalents. Subsequent to the 2015 fiscal year end, the company announced the closing of a registered direct placement with $2.6 million in gross proceeds received from the offering.

Based on management’s current projections, the Company has enough capital to fund its operations into the third quarter of 2016.

(Filing, 10-K, DelMar Pharmaceuticals, SEP 3, 2015, View Source [SID:1234507396])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On Septenber 3, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that the Phase 2b clinical trial design of its clinical trial in small-cell lung cancer (SCLC) will be presented in the P3.07 Poster Session on SCLC at the 16th World Conference on Lung Cancer in Denver, Colorado, September 6 – 9, 2015 (Press release, CytRx, SEP 3, 2015, View Source;p=RssLanding&cat=news&id=2085122 [SID:1234507391]). Entitled "Phase 2 Study of Aldoxorubicin versus Topotecan for Relapsed/Refractory Small Cell Lung Cancer" (Poster # 1736), the poster will be available starting at 9:30 AM MDT, on September 9, 2015. Additionally, aldoxorubicin will be discussed in the Novel SCLC Therapies Mini Symposium (MS 16) on September, 8, 2015.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to present the aldoxorubicin Phase 2b clinical trial design in SCLC at the World Conference on Lung Cancer," said Steven A. Kriegsman, Chairman and Chief Executive Officer. "We believe this will raise awareness of aldoxorubicin’s potential to treat patients with relapsed or refractory SCLC, a devastating disease with a large unmet need. In prior Phase 1 trials, we have seen encouraging evidence of SCLC patients with tumor shrinkage and prolonged stable disease. Our previous data in relapsed or refractory solid tumor patients indicates that the dose of aldoxorubicin being administered to these patients is well tolerated and without any treatment-limiting side effects. Up to 21 cycles (4.8 grams/m2) have been given to one patient with small cell lung cancer with minimal side effects and good anti-tumor activity."

The Phase 2b trial is currently enrolling 132 patients at 37 sites in the USA, Hungary and Spain. Patients with metastatic small cell lung cancer who have either relapsed or were refractory to prior chemotherapy will receive either aldoxorubicin or topotecan in a 1:1 randomization. The primary endpoint for the trial is progression-free survival. Overall survival and safety are secondary endpoints.

About Small Cell Lung Cancer

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases were diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.