On May 17, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company and its collaborators from MD Anderson Cancer Center will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1 clinical trial, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago, Illinois (Press release, Cotinga, MAY 17, 2018, View Source [SID1234533154]).

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Abstract Title: COTI-2, a potent orally available small molecule targeting mutant p53, with promising efficacy as monotherapy and combination treatment in preclinical tumor models
Session Date and Time: Saturday, June 2nd, 2018 1:15 PM – 4:45 PM Central Time
Session Location: McCormick Place South, Hall A, Poster Board 28

Phase 1b/2a Trial of COTI-2
The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and head and neck squamous cell carcinoma ("HNSCC"). In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy. In March 2018, the Company submitted a protocol amendment to the FDA for to expand the trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval, the Company expects to implement the protocol amendment mid-calendar 2018.

On May 17, 2018 Veru Inc. (NASDAQ: VERU), a urology and oncology biopharmaceutical company, reported the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, showing potent activity in a highly resistant model of human prostate cancer (Press release, Veru, MAY 17, 2018, View Source [SID1234529113]). An abstract of the data was published as part of the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Oral VERU-111 was evaluated in the 22Rv1 prostate cancer model, which represents a highly resistant and aggressive form of the disease possessing androgen receptor splice variants that are commonly found in prostate cancer resistant to hormonal approaches like abiraterone and enzalutamide. In the same model, docetaxel administered by injection did not have significant effect on tumor growth. Animals receiving docetaxel lost weight on the study, a surrogate for toxicity, whereas those on VERU-111 either maintained or gained weight while receiving the drug.

"The findings in this clinically relevant model of prostate cancer provide us with additional support and enthusiasm for evaluating VERU-111 in a Phase 1/2 clinical trial, which is scheduled to commence later this year. This is an animal model in which few drugs have been shown to be active. In addition, VERU 111 may be effective against other tumor types known to be sensitive to taxanes that are already FDA approved," said Mario Eisenberger, MD, the Dale Hughes Professor of Oncology at The Johns Hopkins University.

"Oral VERU-111 has shown positive and encouraging signs to become an important therapeutic option for a particularly challenging form of prostate cancer. We are studying VERU-111 in multiple other cancers, the data of which is also being published at ASCO (Free ASCO Whitepaper) this year. We have begun performing the required toxicity studies and our IND submission and first clinical studies are planned for later this year," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.

About VERU-111
VERU-111 is a novel oral therapy targeting alpha and beta tubulin for the treatment of metastatic prostate, breast, endometrial, ovarian, and other cancers. In 2017, there were approximately 161,000 new cases of prostate cancer in the U.S. and about 25% of these men will die from the disease. In the U.S., 5% of men with prostate cancer will have metastatic cancer and up to 30% of men with high-risk, localized prostate cancer will develop metastatic cancer following initial therapy. The median survival of patients with metastatic prostate cancer ranges from 3.2 to 4.5 years. For these men, the 1st line therapy is androgen deprivation therapy, or medical castration. Although most will initially respond, nearly all these patients will progress to metastatic castration resistant prostate and have a poor prognosis with an average survival of 1.5 years. New 2nd line hormonal agents, like XTANDI (enzalutamide) and ZYTIGA (abiraterone/prednisone) have resulted in an additional four to five months of average survival, but nearly all men on these agents will develop progressive metastatic prostate cancer.

Drugs like VERU-111 that target tubulin, the subunits of microtubules, have been shown to be the most effective targeted cytotoxic chemotherapy for the treatment of metastatic prostate cancer. Microtubules are critical for cancer cell replication to stimulate genes for cancer cell proliferation. Docetaxel and cabazitaxel are examples of FDA-approved chemotherapy drugs that are given intravenously (IV) that target tubulin to treat metastatic prostate cancer. Although effective, the challenges for this class of chemotherapy drugs, also known as taxanes, include that they must be given intravenously (IV) and that the cancer cells develop resistance to taxanes. There are also serious safety concerns with IV taxanes which include serious hypersensitivity reactions, myelosuppression and neurotoxicity such as peripheral neuropathy and muscle weakness.

Unlike taxanes which bind to just the beta subunit of tubulin, VERU-111 binds strongly to both the alpha and beta subunits of tubulin. VERU-111 has: high oral bioavailability; less resistance as it does not interact with multiple drug resistance proteins so it cannot be pumped out of the cancer cell; minimal drug to drug interactions and high activity against many tumor types including: prostate cancer resistant to drugs like enzalutamide, AR-V7 positive and taxanes, as well as triple negative breast cancer, ovarian cancer, pancreatic cancer, lung cancer, and melanoma. In preclinical studies, VERU-111 appears to have less toxicity and less suppression of white blood cells compared to taxanes and other chemotherapy agents.

Production of the VERU-111 active pharmaceutical ingredient and preclinical safety toxicology studies required for an IND are expected to be completed in 2018. We anticipate filing an IND in 2018 and Phase 1/2 studies are planned for late 2018. Phase 1 studies of VERU-111 are planned in men who have metastatic prostate cancer that has progressed while taking androgen deprivation therapy and abiraterone or enzalutamide as well as in patients with metastatic breast, endometrial, and ovarian cancers. In the U.S., there is a $5 billion annual market for 2nd line hormone therapies for prostate cancer and a $4.8 billion annual market for IV-given taxanes and vinca alkaloids chemotherapies (docetaxel $1 billion and cabazitaxel $500 million in prostate cancer) per Decision Resources Group and Allied Market Research. Second line hormonal therapies like enzalutamide and abiraterone/prednisone have almost complete cross-resistance and should not be used in sequence for the treatment of metastatic prostate cancer. VERU-111 could be substituted for IV given docetaxel and cabazitaxel antitubulin chemotherapies. VERU-111 could also be developed as an oral dosing alternative to chemotherapies for the treatment of metastatic breast, endometrial and ovarian cancers as these tumors that responded to IV taxane chemotherapies.

On May 17, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that the Company and its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) will present long-term clinical outcomes for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who failed first line treatment and were subsequently treated with tab-cel (tabelecleucel) in Phase 2 studies (Press release, Atara Biotherapeutics, MAY 17, 2018, View Source [SID1234526755]). The poster will be featured during the upcoming 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), which will be held in Stockholm, Sweden, June 14-17, 2018.

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"Long-term outcomes including survival, durability of treatment responses and safety continue to highlight the potential compelling benefit of tab-cel for patients with EBV-associated lymphomas," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "Under the current standard of care, EBV+ PTLD is an aggressive cancer that often rapidly progresses to death after diagnosis. We remain focused on advancing our late-stage clinical development and working closely with global health authorities to bring tab‑cel to patients with this life-threatening disease as expeditiously as possible."

Results to be presented at the EHA (Free EHA Whitepaper) meeting demonstrate the median survival for tab-cel treated patients with EBV+ PTLD following hematopoietic cell transplant (HCT) who failed rituximab was not reached after 23.3 months of follow-up. The expected median survival for patients with EBV+ PTLD following HCT who have failed rituximab first line therapy is 16-56 days.1,2

The median survival for tab-cel treated patients with EBV+ PTLD following SOT who failed rituximab was 21.3 months, which compares favorably to the expected 12 to 13-month median survival in patients with EBV+ PTLD following solid organ transplant (SOT) who fail to achieve a complete response to first-line therapy with single-agent rituximab.3 One-year overall survival for patients with EBV+ PTLD following HCT and SOT who failed rituximab was 68 and 64 percent, respectively. Tab‑cel was generally well-tolerated with low incidence of treatment-related serious adverse events (SAEs), consistent with previous studies.

Based on the findings from the Phase 2 studies, two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel in patients with EBV+ PTLD who have failed rituximab following HCT or SOT. Results from the first tab-cel Phase 3 study and submission of an EU conditional marketing authorization application are expected in the first half of 2019.

The abstract is available in the program section of the EHA (Free EHA Whitepaper) Annual Congress website and details for the poster presentation are as follows:

Abstract PF401: Long Term Outcomes of Tabelecleucel (Allogeneic Third-Party EBV-Targeted Cytotoxic T Lymphocytes) for Rituximab-Refractory Post-Transplant EBV+ Lymphomas: A Single Center Experience
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Presentation Date & Time: Friday, June 15; 5:30 p.m. to 7:00 p.m. CEST
Authors:Susan Prockop, Ekaterina Doubrovina, Amy Feng, Guenther Koehne, Parastoo Dahi, Esperanza Papadopoulos, Craig Sauter, Stephanie Suser, Willis Navarro, Akshay Sudhindra, Richard O’Reilly
Location: Poster area, Älvsjö building, Stockholm International Fairs and Congress Centre (Stockholmsmässan)

About EBV+ PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas, and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition. Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.

About tab-cel (tabelecleucel; formerly known as ATA129)
Atara’s most advanced T-cell immunotherapy in development, tab-cel, is a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted tab-cel Breakthrough Therapy Designation for EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT), and in October 2016, tab-cel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tab-cel for an expedited approval pathway. In addition, tab-cel has orphan status in the U.S. and EU. Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and Atara is planning a Phase 1/2 study in NPC. Tab-cel is also available to eligible patients with EBV-associated hematologic and solid tumors through an ongoing multicenter expanded access protocol clinical study, positive interim results of which were presented in December 2017 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

On May 17, 2018 Novartis reported it will present data from across its oncology portfolio at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to be held June 1-5 in Chicago; and the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), scheduled for June 14-17 in Stockholm (Press release, Novartis, MAY 17, 2018, View Source [SID1234526773]). With studies highlighting more than 25 compounds investigated in a range of disease areas including breast, renal cell and lung cancers, leukemias and other blood disorders, and myeloproliferative neoplasms (MPNs), the 84 abstracts that are part of the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) scientific programs illustrate the breadth and depth of Novartis’ work in oncology.

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"Novartis is improving the lives of people with cancer through a relentless commitment to scientific innovation," said Liz Barrett, CEO, Novartis Oncology. "Whether examining investigational treatment combinations, investigating treatment options that may redefine treatment goals of diseases like CML, or demonstrating the value of our therapies through real-world studies, Novartis continues to push boundaries as we reimagine cancer."

Novartis data at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting will highlight the following:

New data evaluating Kisqali (ribociclib)* in broad range of patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer and additional update on investigational treatment, BYL719 (alpelisib):

Ribociclib (RIB) + fulvestrant (FUL) in postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): Results from MONALEESA-3 [Abstract #1000; Sunday, June 3, 8:00 AM CDT]
Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with no prior endocrine therapy (ET) for ABC: Preliminary results from the phase 3b CompLEEment-1 trial [Abstract #1056; Saturday, June 2, 8:00 AM CDT]
Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC) who received prior chemotherapy (CT): MONALEESA-7 subgroup analysis [Abstract #1047; Saturday, June 2, 8:00 AM CDT]
First-line ribociclib (RIB) + letrozole (LET) in hormone receptor-positive (HR+), HER2 -negative (HER2-) advanced breast cancer (ABC): MONALEESA-2 biomarker analyses [Abstract #1022; Saturday, June 2, 8:00 AM CDT]
BYLieve: A phase II study of alpelisib (ALP) with fulvestrant (FUL) or letrozole (LET) for treatment of PIK3CA mutant, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC) progressing on/after cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy [Abstract #TPS1107; Saturday, June 2, 8:00 AM CDT]
Data evaluating real-world effectiveness and safety outcomes of first-line Votrient (pazopanib) in patients with advanced renal cell carcinoma (RCC):

Prospective, multinational, observational study of real-world treatment outcomes with pazopanib in patients with advanced or metastatic renal cell carcinoma (PRINCIPAL Study) [Abstract #4574; Saturday, June 2, 8:00 AM CDT]
Comparison of clinical outcomes with first-line pazopanib in clinical trial eligible and non-clinical trial eligible patients with renal cell carcinoma [Abstract #4561; Saturday, June 2, 8:00 AM CDT]
New analyses of ENESTop and ENESTfreedom evaluating Treatment-free Remission (TFR) at 144-week follow-up after Tasigna (nilotinib) treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP):

Long-term treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib: ENESTop 144-week results [Abstract #7003; Saturday, June 2, 4:00 PM CDT]
Long-term treatment-free remission (TFR) following frontline (1L) nilotinib in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENESTfreedom 144-wk results [Abstract #7063; Monday, June 4, 8:00 AM CDT]
Additional data presented at ASCO (Free ASCO Whitepaper) include:

Trametinib in pediatric patients with neurofibromatosis type 1 (NF-1)-associated plexiform neurofibroma: A phase I/IIa study [Abstract #10504; Saturday, June 2, 4:12 PM CDT]
Dabrafenib in pediatric patients with BRAF V600-positive high-grade glioma (HGG) [Abstract #10505; Saturday, June 2, 4:24 PM CDT]
Efficacy and safety results from a phase I/IIa study of dabrafenib in pediatric patients with BRAF V600-mutant relapsed refractory low-grade glioma [Abstract #10506; Saturday, June 2, 4:36 PM CDT]
Phase I/II study of spartalizumab (PDR001), an anti-PD1 mAb, in patients with anaplastic thyroid cancer [Abstract #6024; Saturday, June 2, 1:15 PM CDT]
Phase I/II study of LAG525 ± spartalizumab (PDR001) in patients (pts) with advanced malignancies [Abstract #3012; Monday, June 4, 8:00 AM CDT]
A phase I study of LXH254 in patients (pts) with advanced solid tumors harboring MAPK pathway alterations [Abstract #2586; Monday, June 4, 8:00 AM CDT]
Sandoz, a Novartis division and the pioneer and global leader in biosimilars will present data for the company’s filgrastim biosimilar:

Comparison of efficacy and safety of biosimilar filgrastim in a randomized clinical trial (PIONEER) and real-world practice (MONITOR-GCSF) [Abstract #111; Monday, June 4, 10:21 AM CDT]
Advanced Accelerator Applications, a Novartis company and leader in nuclear medicine theragnostics, will present an update on outcomes from the NETTER-1 study evaluating Lutathera (lutetium Lu 177 dotatate) in patients with progressive midgut neuroendocrine tumors:

First update on overall survival, progression-free survival, and health-related time-to-deterioration quality of life from the NETTER-1 study: 177Lu-Dotatate vs. high dose octreotide in progressive midgut neuroendocrine tumors [Abstract #4099; Sunday, June 3, 8:00 AM CDT]
Novartis data at the 2018 EHA (Free EHA Whitepaper) Annual Congress will highlight the following:

Updates on outcomes with Kymriah (tisagenlecleucel) in adult relapsed or refractory (r/r) patients with diffuse large b-cell lymphoma (DLBCL) and patient-reported quality of life in pediatric and young adult patients with r/r B-cell acute lymphoblastic leukemia (B-ALL)**:

An updated analysis of JULIET, a global pivotal phase 2 trial of tisagenlecleucel in adult patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (DLBCL) [Abstract #S799; Saturday, June 16, 11:30 AM CEST]
Outcomes of young adult patients (>= 18-25 years) with relapsed/refractory (r/r) acute lymphoblastic leukemia (ALL) following treatment with chimeric antigen receptor (CAR) T-cell therapy [Abstract #S1565; Sunday, June 17, 8:00 AM CEST]
Improvement of patient-reported quality of life following tisagenlecleucel infusion in pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia [Abstract #PF181; Friday, June 15, 5:30 PM CEST]
Initial experience in US commercial manufacturing of tisagenlecleucel, a chimeric antigen receptor (CAR)-T cell therapy for pediatric relapsed/refractory B-cell precursor acute lymphoblastic leukemia [Abstract #PS1156; Saturday, June 16, 5:30 PM CEST]
New data evaluating Jakavi (ruxolitinib)*** for patients with myelofibrosis, including those with early stage disease, and patients with polycythemia vera who are resistant to or intolerant of hydroxyurea:

Comparison of ruxolitinib and real-world best available therapy in terms of overall survival and thrombosis in patients with polycythemia vera who are resistant or intolerant to hydroxyurea [Abstract #PF628; Friday, June 15, 5:30 PM CEST]
Safety and efficacy of ruxolitinib (RUX) in patients (pts) with DIPSS low-risk myelofibrosis (MF) in the phase 3B expanded-access JUMP study [Abstract #PF623; Friday, June 15, 5:30 PM CEST]
Predictors of response to ruxolitinib (RUX) in patients (pts) with myelofibrosis (MF) in the phase 3B expanded-access JUMP study [Abstract #PF616; Friday, June 15, 5:30 PM CEST]
Results from 48-week follow-up of the EXPAND study: a phase 1b, open-label, dose-finding study of ruxolitinib in patients with myelofibrosis and low platelet counts (50-99 × 109/L) at baseline [Abstract #PF611; Friday, June 15, 5:30 PM CEST]
Further analyses of ENESTop and ENESTfreedom evaluating TFR at 144-week follow-up after Tasigna (nilotinib) treatment discontinuation in eligible adult patients with Ph+ CML-CP:

Long-term treatment-free remission (TFR) following second-line (2L) nilotinib (NIL) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENESTop 144-wk results [Abstract #PF377; Friday, June 15, 5:30 PM CEST]
Long-term treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) following frontline (1L) nilotinib (NIL): Results from ENESTfreedom [Abstract #PF368; Friday, June 15, 5:30 PM CEST]
Safety analysis of the SUSTAIN study evaluating crizanlizumab in patients with sickle cell disease:

Crizanlizumab treatment is not associated with the development of proteinuria and hematuria in patients with sickle cell disease: A safety analysis from the SUSTAIN study [Abstract #PF712; Friday, June 15, 5:30 PM CEST]
New data evaluating Revolade (eltrombopag) in patients with either persistent or chronic immune thrombocytopenia (ITP):

Eltrombopag treatment improved platelet counts in patients with persistent or chronic immune thrombocytopenia: Efficacy and safety results from the Phase III EXTEND study and a Phase IV study [Abstract #PF671; Friday, June 15, 5:30 PM CEST]
Interim results from the ITP World Impact Survey (I-WISh) about the burden of disease and impact of ITP on patient quality of life and productivity:

The burden of disease and impact of Immune Thrombocytopenia (ITP) on patient quality of life and productivity: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF654; Friday, June 15, 5:30 PM CEST]
Throughout the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting and EHA (Free EHA Whitepaper) Annual Congress, Novartis will host dedicated content on View Source that will feature unique insights and perspectives on emerging areas of cancer care and research.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For full prescribing information, including approved indications and important safety information about marketed products, please visit View Source

For Lutathera full prescribing information, including approved indications and important safety, please visit View Source

Alpelisib (BYL719), LAG525, spartalizumab (PDR001), LXH254 and crizanlizumab (SEG101) are investigational compounds. Efficacy and safety have not been established. There is no guarantee these compounds will become commercially available.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On May 17, 2018 Provectus and POETIC reported preclinical PV-10 data from pediatric cancer research that will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, IL (Press release, Provectus Pharmaceuticals, MAY 17, 2018, View Source [SID1234526789]).

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PV-10 induced cell death in pediatric solid tumor cell lines derived from relapsed pediatric neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma with a measurable therapeutic window compared to normal cells. Western blot analyses of cells treated with PV-10 indicated induction of apoptosis. Drug combination studies showed synergy with radiation and agents that target mitosis. Xenograft studies showed significant reduction of tumor burden in PV-10-treated mice compared to control animals, with a corresponding increase in overall survival.

Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company") is a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for adult and pediatric solid tumor cancers. The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium ("POETIC") is a group of North American academic medical centers developing new pediatric cancer therapies.

Findings will be highlighted in a poster presentation on Saturday, June 2 from 8:00 to 11:30 a.m. CDT in Hall A as part of the Pediatric Solid Tumors topic during the Pediatric Oncology session. The POETIC poster title is "In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors," the poster board number is 230, and the abstract number is 10557.

This preclinical pediatric cancer research was led by Aru Narendran, MD, PhD and researchers at the POETIC Laboratory for Pre-Clinical and Drug Discovery Studies at the University of Calgary (Canada), together with Tanya Trippett, MD, Director of POETIC and researchers at Memorial Sloan Kettering Cancer Center.

Dr. Trippett said, "POETIC’s mission is to promote the early clinical development of promising therapies for the treatment of children, adolescents, and young adults with cancer. We hope our collaboration with Provectus on PV-10 leads to an opportunity to improve cancer care for children around the world."

Ed Pershing, Chair of Provectus’ Board of Directors, said, "We are thrilled to work alongside POETIC and its member institutions in Canada and the U.S. in an effort to jointly advance options for pediatric cancer patients around the globe."

About PV-10

Provectus’ lead investigational cancer drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers such as Ewing sarcoma, neuroblastoma, osteosarcoma, and rhabdomyosarcoma.

About the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium

The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) was founded in February 2003 by Dr. Tanya Trippett at Memorial Sloan Kettering Cancer Center and Dr. Lia Gore at the University of Colorado Cancer Center. POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive cancer care and research that provide the collaborative and research strength needed to complete intensive phase I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and adolescent populations. POETIC’s assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH-funded pediatric and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science and translational research programs at the institutions allows focus on the development and evaluation of new therapeutic strategies for patients with cancer and related disorders. POETIC’s pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and evaluate novel agents and/or combinations of therapies early in clinical development as well as new approaches to targeted delivery. For additional information about POETIC, please visit the Consortium’s website at www.poeticphase1.org.