harmsen
8 years ago
SYDNEY, AUSTRALIA--(Marketwired - Aug 10, 2016) - Prima BioMed Ltd (NASDAQ: PBMD) (ASX: PRR) ("Prima", the "Company"), has received notification from the Listing Qualifications Department of The NASDAQ Stock Market (the "Staff") indicating that, for the period from June 24, 2016 through August 5, 2016, the closing bid price of the Company's American Depositary Shares, or ADS, had not been maintained at the minimum required closing bid price of at least US$1.00 per share as required for continued listing on The NASDAQ Global Market pursuant to NASDAQ Listing Rule 5450(a)(1) (the "Minimum Bid Price Rule").
Prima has a period of 180-calendar days, or until February 6, 2017, to regain compliance with the Minimum Bid Price Rule. Within any time during the 180-day period the minimum closing bid price per share of the ADSs closes at or above US$1.00 for a minimum of ten consecutive business days, the Staff will provide written notification to the Company that it complies with the Minimum Bid Price Rule and the matter will be closed. Prima's management is looking into various options available to the Company in order to regain compliance and maintain its continued listing on The NASDAQ Global Market.
harmsen
8 years ago
Prima BioMed Collaborates in Investigator Sponsored New Clinical Trial for IMP321 in Solid Tumors.
SYDNEY, AUSTRALIA--(Marketwired - Jul 12, 2016) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) today announced a new collaborative study investigating the intra-tumoural injection of IMP321. The investigator sponsored study will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany ("IKF"; Institute for clinical oncology research at the Northwest University Hospital in Frankfurt). The new study will explore the potential for IMP321 as an activator of dendritic cells found within solid cancer tumours.
The new clinical trial is called "INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities."
The Lead Investigator of this up-to-40-patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.
Dr Al-Batran commented: "The promising results from previous studies and favourable safety profile of IMP321 have led us to conduct a phase I trial investigating a potential enhancement of the immune-activating effects of IMP321 by new routes of administration. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumour entities."
Marc Voigt, Chief Executive of Prima, said: "This is potentially an exciting new therapeutic application for IMP321 and is the result of the extensive research carried out by Dr Frédéric Triebel and the Prima team in our Paris laboratory. It is the first ever investigation into whether direct injection of IMP321 into a solid tumour can activate the antigen presenting cells located inside the tumour to boost the body's immune response. As this trial is investigator initiated, it will also not require any significant near-term resource commitment from Prima."
Clinical Trial Synopsis
Title of Study INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities
Objectives Feasibility, safety and toxicity
Immune response in whole blood and tumour tissue
Identification of biomarkers that correlate with clinical response / clinical outcome
Study design Monocentre, open-label, phase I study
Planned Sample size Up to 40 patients
Clinical trial identifier: To be determined
harmsen
8 years ago
Prima BioMed Announces First Safety, Pharmacokinetics, Immuno-Monitoring Data From Phase IIb Clinical Trial of IMP321 -
Prima BioMed Ltd (NASDAQ: PBMD) is pleased to announce initial safety data from the first cohort of patients in its Phase IIb AIPAC chemo-immunotherapy clinical study of Prima's lead compound, IMP321.
AIPAC ( A ctive I mmunotherapy PAC litaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321-plus-paclitaxel in hormone receptor-positive metastatic breast cancer. The trial is currently being conducted out of Belgium, The Netherlands and now also Hungary, with further European sites to be initiated in the future.
The first six patients have received 6 mg doses of IMP321 in combination with paclitaxel. This dose has proved to be safe and well tolerated with no drug related serious adverse events. The data also demonstrated activation of blood monocytes/dendritic cells and CD8 T cells.
Prima's Chief Medical Officer, Dr Frederic Triebel, said: "The data from this initial open-label run-in cohort of six patients confirms the safety, pharmacokinetics and pharmacodynamics of IMP321 and we are encouraged to have met our anticipated timelines for recruitment. We will now start enrolling nine additional patients in the second cohort with 30 mg of IMP321, with the results of both cohorts to be presented and compared in the fourth quarter of 2016. Then the randomisation phase with the recommended phase IIb dose will begin enrolling approximately 196 patients."
Prima's CEO, Marc Voigt, commented: "We are pleased to have confirmed previous results at the 6 mg dose in metastatic breast cancer. We believe that the interim results obtained at 6 mg significantly de-risk the remainder of the trial as the previous phase I/IIa trials provided very encouraging results with that dose level."
The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint. Details of the AIPAC study are available at NCT 02614833 .