On March 31, 2017 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that its Board of Directors has approved a corporate name change and ratio for the reverse stock split of the issued and outstanding shares of common stock (Press release, Propanc, MAR 31, 2017, View Source [SID1234518414]). The Company had previously announced that the Board and a majority of its voting stockholders had approved a range for a reverse stock split and a reduction in the number of authorized shares of common and preferred stock of the Company.

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!

The Company’s name will change to Propanc Biopharma Inc. on April 7, which symbolizes a new and exciting growth phase for the Company, as it heads towards First-In-Man studies for its lead product, PRP.

Also, it is expected that prior to the commencement of trading on April 7 a 1-for-250 reverse stock split will be effectuated. The number of authorized shares of common stock will be reduced from 2 billion to 100 million and the number of authorized shares of preferred stock of the Company reduced from 10 million to just over 1.5 million. Investors should note that for 20 trading days after the reverse stock split, the ticker symbol of the Company’s common stock will change to PPCHD.

"As a result of the Company’s recent progress and anticipated upcoming milestones, we believe the timing is right to change our Company name to better reflect our stage of growth and development, as well as execute the reverse stock split," said James Nathanielsz, Propanc’s Chief Executive Officer. "Given that we expect to complete our GLP toxicity study very soon and expect to then move forward with First-In-Man studies of our lead product, PRP, we wanted to launch our corporate strategy to address our capital structure, reduce debt, and raise additional capital sufficient to progress PRP through clinical development. By undertaking these steps, management hopes to better position the Company for an up-listing of our common stock to a national stock exchange in order to help ensure the long-term future of the Company and create value for its shareholders."

The Company’s lead product, PRP, is a novel, patented, formulation consisting of two pancreatic proenzymes, trypsinogen and chymotrypsinogen. Currently in preclinical development and progressing towards First-In-Man studies, PRP aims to prevent tumor recurrence and metastasis in solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.

To view Propanc’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc’s email distribution list, please email [email protected] with "Propanc" in the subject line.

On March 31, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that updates on several of its preclinical programs are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Washington, D.C (Press release, Mateon Therapeutics, MAR 31, 2017, View Source [SID1234518365]).

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!

"These abstract presentations show the breadth of some of our early preclinical development programs," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "As this work matures, we look forward to it complementing our current core clinical programs in platinum-resistant ovarian cancer and acute myeloid leukemia."

Poster presentations by Mateon and/or its collaborators at the AACR (Free AACR Whitepaper) annual meeting are as follows:

Abstract #2952 – The novel Cathepsin L/K inhibitors KGP94 and KGP207 prevent M0 to M2 macrophage differentiation and macrophage mediated pro-tumor functions.
Section: Tumor Microenvironment 3
Date and Time: Monday, April 3, 2017, 1:00 p.m. – 5:00 p.m. Eastern Time

Abstract #3203 – Targeting tumor hypoxia with prodrug conjugates of potent small molecule inhibitors of tubulin polymerization
Section: Novel Molecular Targets 2
Date and Time: Tuesday, April 4, 2017, 8:00 a.m. – 12:00 p.m. Eastern Time

Abstract #4899 – The small molecule Cathepsin L and K inhibitor KGP-94 impairs the metastatic phenotype of osteosarcoma cells
Section: Therapeutic Intervention of Cancer and Metastases
Date and Time: Tuesday, April 4, 2017, 1:00 p.m. – 5:00 p.m. Eastern Time

The above abstracts have been published and can be viewed on the AACR (Free AACR Whitepaper) Annual Meeting website.

On March 31, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported the presentation of positive overall survival data from an open-label, randomized, Phase 2 study designed by the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer Institute of Canada – NCIC) (Press release, Oncolytics Biotech, MAR 31, 2017, View Source [SID1234518366]). The 74-patient study, powered to 90 percent, assesses the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer. Data from the study (IND 213), will be presented during the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 1-5, in Washington, DC.

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!

The abstract reports that in the intention-to-treat (ITT) patient population there was an improvement in median OS (secondary endpoint) from 10.4 months on the control arm to 17.4 months on the test arm (Hazard ratio 0.65, 80% CI 0.46-0.91, p=0.1), meeting the pre-specified significance level for the 90 percent powered study. Consistent with REOLYSIN acting as an immune therapy agent, there was no meaningful improvement in either progression free survival (the primary endpoint), or response rate (secondary endpoint). The Company is now planning a registration study in metastatic breast cancer with overall survival as the primary endpoint.

"This is the first controlled, randomized study where the systemic administration of an immuno-oncology viral agent (REOLYSIN), was well tolerated and had a significant impact on the overall survival of relapsed metastatic breast cancer patients when used in combination with paclitaxel," said Dr. Karen Gelmon, Head, Investigational Drug Program, Experimental Therapeutics, Department of Medical Oncology, British Columbia Cancer Agency.

"There is an emerging pattern, from this and other studies with REOLYSIN, where patients obtain significant benefit in overall survival, despite limited impact on response rates and/or progression-free survival," said Dr. Andres Gutierrez, Chief Medical Officer of Oncolytics. "This is a well-established pattern for other immunotherapies, like checkpoint inhibitors, which have been approved on an overall survival primary endpoint in melanoma, NSCLC and head and neck cancers. These phase 2 data also support the established mode of activity of REOLYSIN where selective cell lysis of permissive cancer cells is followed by an anti-tumor immune response, which may be responsible for the meaningful survival benefit for patients. Taking into account the specific findings from this study, we continue to believe that REOLYSIN is not solely an oncolytic agent, but has key attributes of an immuno-oncology agent as well."

The abstract, authored by Bernstein et al, "A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC)" is now available on the AACR (Free AACR Whitepaper) website. CCTG will be making a poster presentation, #8466, at the AACR (Free AACR Whitepaper) Annual Meeting, on Tuesday Apr 4, 2017 from 1:00 PM – 5:00 PM, in Washington, DC.

Oncolytics would like to thank the patients that participated in this study, the CCTG and all the physicians and nurses involved.

About Breast Cancer
The American Cancer Society estimates there will be 255,180 new cases of breast cancer diagnosed in the United States and 41,070 deaths from the disease in 2017.

On March 31, 2017 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, IBRANCE (palbociclib), based on the results from the confirmatory Phase 3 trial PALOMA-2 (Press release, Pfizer, MAR 31, 2017, View Source [SID1234518368]). The FDA action converts the accelerated approval of IBRANCE to regular approval and broadens the range of anti-hormonal therapy that may be administered with IBRANCE. IBRANCE now is indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole, as initial endocrine based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

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!

IBRANCE is the first CDK 4/6 inhibitor approved by the FDA. IBRANCE was granted accelerated approval in combination with letrozole in February 2015 and regular approval in February 2016 for a second indication: the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Today, IBRANCE plus letrozole is the most prescribed FDA-approved oral combination treatment for HR+, HER2- metastatic breast cancer.

"In the two years since its initial approval, IBRANCE has been prescribed to more than 50,000 patients by more than 9,800 physicians in the U.S.," said Liz Barrett, global president and general manager, Pfizer Oncology. "This important update to the IBRANCE label underscores the strength of the data we continue to generate for IBRANCE. We are proud of the impact this innovative medicine continues to have on patients’ lives."

The updated label is based on data including results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE as first-line therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive (ER+), HER2- metastatic breast cancer. These data were published in the November 17, 2016 issue of The New England Journal of Medicine. PALOMA-2 demonstrated that the combination of IBRANCE and letrozole significantly extended progression-free survival (PFS), or the amount of time before tumor growth, compared with letrozole plus placebo. The median PFS of the IBRANCE and letrozole combination exceeded two years – making it the first treatment for this population of women to do so in a Phase 3 study. The median PFS for women treated with IBRANCE plus letrozole exceeded the median PFS for placebo plus letrozole by more than 10 months (24.8 months [95% CI, 22.1, not estimable] vs. 14.5 months [95% CI, 12.9, 17.1] for women treated with letrozole plus placebo (HR=0.58 [95% CI, 0.46, 0.72], p<0.0001)), and represented a 42% reduction in the risk of disease progression.

The warnings and precautions of IBRANCE include neutropenia and embryo-fetal toxicity. Adverse reactions in PALOMA-2 were generally consistent with the known adverse reaction profile for IBRANCE and no major unexpected safety findings were observed. The most common grade 3/4 adverse reactions with IBRANCE plus letrozole versus placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%) and anemia (5% vs 2%). Febrile neutropenia was reported in 2.5% of patients in the IBRANCE plus letrozole group and none of the patients in the placebo plus letrozole group.

Palbociclib (IBRANCE) is the only treatment for HR+, HER2- metastatic breast cancer with two category 1 recommendations from the National Comprehensive Care Network (NCCN). On March 13, the NCCN updated their recommendation for palbociclib plus letrozole as a first-line treatment for postmenopausal women with HR+, HER2- metastatic breast cancer to a category 1 recommendation.1 In addition, palbociclib plus fulvestrant is recommended (category 1) for postmenopausal women with HR+, HER2- metastatic breast cancer who have progressed on endocrine therapy or premenopausal women receiving a luteinizing hormone-releasing hormone (LHRH) agonist.1

The full prescribing information for IBRANCE can be found here.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients withsevere renal impairment (CrCl <30 mL/min).

About IBRANCE (palbociclib) 125 mg capsules

IBRANCE is an oral inhibitor of CDKs 4 and 6,2 which are key regulators of the cell cycle that trigger cellular progression.3,4 In the U.S., IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.

Including the U.S., IBRANCE is approved in more than 60 countries.

Development Pipeline Progress Status (Summary) in Third Quarter of Fiscal Year Ending March 31, 2017 The followings summarize the changes in development status progressed from the announcement of financial results at the 2 nd Quarter of the fiscal year released on November 7, 2016. For details, please refer to pages 12 to 17 of the 3 rd Quarter Flash Report (Filing, 3 mnth, MAR 31, Ono, 2017, MAR 31, 2017, View Source [SID1234519525]). Development status of ONO products excluding ONO-4538/Opdivo (nivolumab) (Japan) Parsabiv  Intravenous Injection for Dialysis (ONO-5163/etelcalcetide hydrochloride), a calcium sensing receptor agonist An application for manufacturing and marketing approval of Parsabiv was approved for the treatment of secondary hyperparathyroidism on hemodialysis on December 19, 2016. The NHI price listing is expected to be this February. Orencia  Subcutaneous Injection (ONO-4164/ BMS-188667), a T-cell activation inhibitor Global Phase III clinical study of Orencia was started for the treatment of primary Sjögren syndrome. ONO-4578, a Prostaglandin E2 receptor (EP4) antagonist Phase I clinical study of ONO-4578 was initiated for solid tumor. (Outside of Japan) ONO-4059, a Bruton’s tyrosine kinase (Btk) inhibitor Phase II clinical study of ONO-4059 was started for the treatment of B cell lymphoma in the US by our licensee, Gilead Sciences, Inc. ONO-7475, an Axl /Mer inhibitor Phase I clinical study of ONO-7475 was initiated for the treatment of acute leukemia in the US. ONO-7579, a Tropomyosin receptor kinase (Trk) inhibitor Phase I clinical study of ONO-7579 was initiated for solid tumor in Europe and the US. ONO-2952, a Translocator protein (TSPO) antagonist ONO-2952 had been developed for potential treatment of diseases caused due to stress by suppressing the production of neuroprotein causing stress. However, the development of ONO-2952 for the treatment of irritable bowel syndrome was discontinued due to the strategic reason considering differentiation among existing products and competing products under development and others comprehensively. ONO-4232, a P rostaglandin E2 receptor (EP4) agonist The development of ONO-4232 for the treatment of acute heart failure was discontinued due to the strategic reason considering future development period, development cost and others comprehensively. Development status of ONO-4538/Opdivo (nivolumab), etc. ONO-4538/Opdivo (Japan, South Korea and Taiwan)-An application of Opdivo for a partial change in approved items of the manufacturing and marketing authorization was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma, a blood cancer, in Japan on December 2, 2016.-An application of O pdivo for a partial change in approved items of the manufacturing and marketing authorization was submitted for the indication of unresectable advanced or recurrent gastric cancer in Japan on December 27, 201 6.-Phase III clinical study was started for the treatment of ovarian cancer in Japan. ONO-4538/ Opdivo (US and Europe)-In the US, a supplemental Biologics License Application (sBLA) of Opdivo was approved for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.-In Europe, Opdivo was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.-In the US, Phase I clinical study was initiated for the treatment of sepsis. ONO-4686/BMS-986207, an Anti-TIGIT antibody (Japan, South Korea and Taiwan) Phase I/II clinical study was initiated for solid tumors in Japan.

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!