On December 6, 2017 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) reported that it will have two presentations at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held Dec. 9-12, 2017 in Atlanta (Press release, ProMetic Life Sciences, DEC 6, 2017, View Source [SID1234522398]).

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An oral presentation, entitled, "Pivotal Trial with Intravenous Plasminogen Replacement in Patients with Plasminogen Deficiency Demonstrates Long-Term Efficacy for Treatment and Prevention of Ligneous Lesions" will be presented by Dr. Charles T. Nakar, Indiana Hemophilia and Thrombosis Center. During the oral session, Dr. Nakar will present 48-week data demonstrating the long-term safety and efficacy of intravenous plasminogen replacement (RyplazimTM) in patients with plasminogen deficiency.

A poster presentation, entitled, "Computer Modeling Using Historical Data Demonstrates a Significant Reduction in Expected Extravascular Fibrinous Lesions Due to Congenital Plasminogen Deficiency While Receiving Intravenous Plasminogen Replacement" will be presented by Dr. Joseph M. Parker, Senior Director of clinical development of Prometic. Dr. Parker will present a poster of historical data computer modeling highlighting the significant treatment effect of RyplazimTM in reducing the extravascular ligneous lesions in pediatric and adult subjects with plasminogen deficiency.

"Data from these presentations demonstrates the remarkable safety and efficacy profile of plasminogen treatment we have observed to date," said Pierre Laurin, Chief Executive Officer at Prometic. "No currently-available treatment options have demonstrated a complete resolution of lesions in patients with plasminogen deficiency. We are continuing to work closely with the FDA with the goal of making our plasminogen replacement therapy available to patients as soon as possible."

Details of the oral presentation are as follows:

Presentation Title: Pivotal Trial with Intravenous Plasminogen Replacement in Patients with Plasminogen Deficiency Demonstrates Long-Term Efficacy for Treatment and Prevention of Ligneous Lesions

Presenter: Charles T. Nakar, M.D.

Session Title: Disorders of Coagulation or Fibrinolysis: Novel Therapies and Clinical Trials in Bleeding Disorders
Date/Time: Saturday, December 9, 2017 at 9:30 a.m. EST
Room: Georgia World Congress Center, Bldg B, Lvl 2, B207-B208

Details of the poster presentation are as follows:

Presentation Title: Computer Modeling Using Historical Data Demonstrates a Significant Reduction in Expected Extravascular Fibrinous Lesions Due to Congenital Plasminogen Deficiency While Receiving Intravenous Plasminogen (PLG) Replacement

Presenter: Joseph M. Parker, M.D.
Session Title: Disorders of Coagulation or Fibrinolysis: Poster II
Date/Time: Sunday, December 10, 2017 from 6:00 p.m. to 8:00 p.m. EST
Room: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

On December 5, 2017 At the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 59th Annual Meeting and Exposition in Atlanta, Georgia, researcher Gustavo Milone, MD, and his team reported that will present a study that investigates the post-marketing trends of Novex, a biosimilar rituximab that has been approved in Argentina for the same indications as the reference product (MabThera, Rituxan) (Press release, mAbxience, DEC 5, 2017, View Source [SID1234594760]).1 Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

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In order to determine deviations from expected frequencies of adverse events (AEs), a prospective treatment registry for the biosimilar was implemented from the start of its commercialization on November 26, 2014. Data in the study are reported until June 30, 2017. Physicians, 180 in total, tracked age, gender, indication, dose, dose frequency, and date of treatment initiation and finalization for each patient receiving the biosimilar.

The study comprised the records of 525 patients who had at least 1 follow-up. The majority of patients were female (52%), the mean age was 63.3 years (range, 10-90), and most patients received the biosimilar rituximab for hematological disease (91.2% of cases). The treatment duration ranged from 154 to 309 days, with the number of treatment cycles varying from 1 to 12. Individual Case Safety Reports (ICSRs) were collected from 24 patients with 29 AEs.

The most frequently reported AEs were:

Acute infusion-related reaction (14)
Arrhythmia (3)
Pneumonia (2)
Stroke (2)
The researchers noted that 41 treatments with rituximab were initiated before the launch of the product; assuming treatment began with MabThera, these 41 treatments imply switching to the biosimilar from the reference.

Researchers investigating data from the post-marketing surveillance found a similar incidence of AEs after the use of rituximab biosimilar when compared to the published data of the reference product. Thus, in terms of tolerability, the biosimilar has a similar safety profile compared with its reference.

On December 5, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that updated clinical data from its lead product candidate CB-839, a first-in-class glutaminase inhibitor, will be presented at the 2017 San Antonio Breast Cancer Symposium, December 5-9, 2017 in San Antonio, Texas (Press release, Calithera Biosciences, DEC 5, 2017, View Source [SID1234535249]). The data demonstrate the clinical activity and tolerability of CB-839 in combination with paclitaxel, and highlight the unique mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (TNBC). Based on these data, Calithera has opened a Phase 2 trial exploring the treatment combination in both first line and late line metastatic TNBC patients.

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"Effective treatment for triple negative breast cancer in the advanced and metastatic population remains a significant unmet need. In our Phase 1 study, we were pleased to have observed responses in patients who were heavily pretreated and the Phase 2 study will help us further understand the role of CB-839 in inhibiting glutaminase to help control the progression of cancer in advanced metastatic TNBC patients," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.

In a poster presentation representing an update from data presented at SABCS 2016, Dr. Kevin Kalinsky from Columbia University Medical Center will present, "Phase I study of CB-839, a first-in-class inhibitor of glutaminase, in combination with paclitaxel in patients with advanced triple negative breast cancer," (Abstract PD3-13). Eligible patients must have locally advanced/metastatic TNBC, with no restrictions on prior exposure to taxanes, or the number of prior therapies. As of October 23, 2017, 49 triple negative breast cancer patients had been treated with doses of CB-839 of 400, 600 or 800 mg bid in combination with 80 mg/m2 IV paclitaxel, weekly, three weeks out of four; 44 were evaluable for response. Patients were heavily pretreated, having received a median of 3 prior therapies for advanced metastatic disease. A majority of patients had received prior taxane therapy in either the neo-adjuvant (37%) or metastatic setting (51%). Among all evaluable patients treated with CB-839 doses of at least 600 mg bid (n=37), there were 8 partial responses (22%) and disease control (response or stable disease) in 22 patients (59%). Among African Americans, there was a 36% response rate in patients who had received previous taxanes in the metastatic setting; all responders were refractory to prior taxanes. Exploratory biomarker analysis shows a trend for the strongest clinical benefit occurring in patients with LAR and/or desmoplastic stromal gene expression signatures1.

The combination of CB-839 and paclitaxel has been well tolerated to date, with adverse events that have been primarily low grade and reversible. Consistent with the previous report, there was one case of dose-limiting, recurrent grade 3 neutropenia at the 400 mg dose level, which led to a reduction in the dose of paclitaxel for that patient. The most frequent adverse event ≥ Grade 3 was neutropenia (27%). A low rate of ≥ Grade 3 peripheral neuropathy (4.2%) was observed despite 88% of the patients having prior taxane exposure. 1Lehmann et al., J Clin Invest 2011; Chen et al, Cancer Inform 2012; Jovanovic et al BMC Cancer 2017; Saleh et al, Cancer Research 2017

About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents

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On December 5, 2017 Medidata (NASDAQ:MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, reported that CytomX Therapeutics, Inc., a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, will expand its partnership to include Medidata Regulated Content Management (RCM) solutions, eTMF Archive and SOP Management (Press release, CytomX Therapeutics, DEC 5, 2017, View Source [SID1234522418]).

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"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance"
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With the addition of Medidata RCM, CytomX will now manage regulated and nonregulated content in a single, unified platform. Accessible through the Medidata Clinical Cloud, CytomX will integrate standard operating procedure (SOP) management and electronic trial master file (eTMF) archive to manage all content, data and workflows.

CytomX is also currently using Medidata Rave, the world’s leading solution for capturing, managing and reporting patient data and Medidata Balance, randomization and trial supply management (RTSM) application, for its oncology research studies.

"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance," said Mike Capone, chief operating officer at Medidata. "Medidata’s industry difference is that we enable our customers to take control of their data, helping them meet regulatory requirements and ensure efficient clinical trials."