Key Developments: Prima BioMed Ltd (PRR.AX)

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Latest Key Developments (Source: Significant Developments)

Prima Biomed Ltd receives US patent grant for CVAC
Tuesday, 15 Jul 2014 09:00pm EDT 

Prima Biomed Ltd:Says that the US patent number 8,771,701 titled "compositions for immunotherapy and uses thereof”, which protects the company’s CVac technology, has been granted by the United States Patent and Trademark Office.Prima has also received a patent term adjustment of 1,409 days for US 8,771,701, extending the patent expiry date for the US market to Aug. 2022.  Full Article

Prima Biomed announces management change
Wednesday, 9 Jul 2014 03:59am EDT 

Prima Biomed Ltd:Appoints Marc Voigt as Chief Executive Officer.Replaces Matthew Lehman who will step down from the Board but remain as an adviser.  Full Article

Prima BioMed Ltd's CVAC demonstrates positive trend in overall survival in second remission ovarian cancer
Sunday, 1 Jun 2014 06:27pm EDT 

Prima BioMed Ltd:Says CVac has demonstrated a positive trend in overall survival (OS) over standard of care in second remission ovarian cancer patients in the CAN-003 protocol.Interim overall survival data from CAN-003 clinical trial demonstrates positive trend in second remission ovarian cancer patients.Medians for the control group and CVac treated patients have not yet been reached for first remission patients.Primary objectives of the trial are to determine the safety of CVac administration and to determine CVac’s effect on progression-free survival.Secondary objectives of the trial are to determine CVac’s effect of overall survival and to evaluate host immunologic responses to CVac.  Full Article

Prima Biomed Ltd's CVAC GRANTED secures Fast Track Designation by FDA
Thursday, 8 May 2014 08:00pm EDT 

Prima Biomed Ltd:Says that the United States Food and Drug Administration granted Fast Track Designation to the CVac clinical development program at Prima.This program is intended to improve overall survival in patients with relapsed platinum-sensitive epithelial ovarian cancer who enter a second complete remission.Prima will work closely with the FDA in accelerating its development program for CVac to potentially bring this treatment option to patients in the U.S.  Full Article

Prima Biomed Ltd and Neopharm Group execute final agreement for CVac license
Thursday, 20 Feb 2014 05:08pm EST 

Prima Biomed Ltd:Finalizes an agreement with Neopharm Group (Neopharm) for an exclusive license (License) to market and sell CVac, a immunocellular therapeutic under investigation for the treatment of epithelial ovarian cancer, in Israel and the Palestinian Authority.Under the terms of the License, Neopharm will reimburse Prima for commercial manufacturing costs of CVac and then Prima and Neopharm will split net profits from CVac sales in the License territory.Says it will also receive small up-front and development milestone payments.  Full Article

Prima Biomed Ltd announces approval of CAN-004 clinical trial amendment in Belgium
Thursday, 16 Jan 2014 10:59pm EST 

Prima Biomed Ltd:Says that the amended CAN-004 protocol was approved by the Belgian Federal Agency for Medicines and Health Products.Says this is the first regulatory agency to approve the amended CVac clinical trial design.Says CAN-004 is a multicentre, randomized, phase 2 trial of CVac for the maintenance treatment of epithelial ovarian cancer in remission.Says the CAN-004 trial will enrol a new cohort of 210 epithelial ovarian cancer patients in remission after second-line platinum-based chemotherapy.Says 76 patients in remission after first-line surgery and chemotherapy have previously been randomized onto the CAN-004 trial. Overall survival (OS) will be the primary endpoint with secondary endpoints including progression-free survival (PFS), adverse events, and immune monitoring.  Full Article

Prima Biomed Ltd Announces Top Line Analysis Of Cvac Phase 2 Trial
Wednesday, 18 Sep 2013 04:55am EDT 

Prima Biomed Ltd announced top-line analysis of the CAN-003 phase 2 study of CVac for treatment of epithelial ovarian cancer patients in first or second remission. Results indicate that CVac was generally well tolerated, with no Serious Adverse Events (SAEs) considered related to protocol therapy. The majority of non-Serious Adverse Events (AEs) were considered mild and transient in nature. While variable, immune monitoring data indicate that CVac induces a T cell response which may be beneficial for patients with ovarian cancer. No evidence was seen of a humoral (or antibody) response after CVac administration which is also considered a positive signal. Although this study was not adequately powered to detect statistical significance, the estimate of median progression-free survival (PFS) for all randomized patients resulted in no observed difference between the CVac and control groups. The median PFS was also estimated separately for patients in first and second remission. In first remission, the median PFS favored the control arm when compared to the CVac treated patients. In second remission, the median PFS favored CVac as compared to patients on the control group. However, neither of these trends was statistically significant. It is considered too early to make conclusions based on Overall Survival (OS) data. Prima will continue to monitor patient outcomes on the CAN-003 trial until overall survival data matures.  Full Article

Prima Biomed Ltd Files U.S. Shelf Registration Statement
Wednesday, 28 Aug 2013 08:53pm EDT 

Prima Biomed Ltd announced that it has filed a shelf registration statement on Form F-3 with the U.S. Securities and Exchange Commission (SEC). When effective, the registration statement would allow the Company to issue, over a period of three years from time to time, up to a total of USD60 million worth of ordinary fully paid shares in the Company (which will trade in the United States in the form of American depository shares (ADS)). Shelf registrations are common practice in the United States as they allow a company to complete the usually extensive SEC review process prior to the issuing of any securities and then have up to three years within which to use the prospectus. The registration statement relating to these potential future issues has been filed with the SEC, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This announcement shall not construe an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offering of these securities shall be made only by means of a prospectus contained in the registration statement filed with and declared effective by the SEC.  Full Article

Prima Biomed Ltd Announces Issue Of Fully Paid Ordinary Shares
Thursday, 18 Jul 2013 08:46pm EDT 

Prima Biomed Ltd announced that it has issued: (a) 16,412,500 Shares issued to certain sophisticated and professional investors in accordance with the shareholder approval obtained at the EGM on May 16, 2013 to issue SPP shares shortfall shares (Shortfall Placement); and (b) three 16,412,500 Shares issued to certain sophisticated and professional investors in accordance with the shareholder approval obtained at the EGM on May 16, 2013 to issue SPP shares shortfall shares (Shortfall Placement). Issue price or consideration is: (a) $0.08 per Share (with respect to the Shares issued under the Shortfall Placement); and (b) $0.20 per Share (with respect to the Shares issued following the Options Exercise). The purpose of the issue is for: the funds raised under the Shortfall Placement will be applied towards: co-funding up to three phase 2 trials of CVac in additional cancer indications and continuing the ongoing clinical program; continuing CVac manufacturing optimisation programs to move toward a global product manufacturing platform; providing general working capital for the Company and adding security to the balance sheet; and for general working capital.  Full Article

Prima Biomed Ltd Awarded Japanese Patent for CVAC
Wednesday, 17 Apr 2013 02:30am EDT 

Prima Biomed Ltd announced that it has been granted a patent from the Japanese Patent Office that protects methods used in the manufacture of CVac. The method of use claims secured in patent number 5192020 entitled “Use of mannose receptor-bearing antigen presenting cells for the manufacture of medicament for eliciting cytotoxic T cell response to antigen” provide for the treatment of patients with dendritic cells that have been pulsed with mannan fusion protein (M-FP) conjugated to an antigen, including but not limited to mucin 1.  Full Article

Prima BioMed's therapy improves survival rates in ovarian cancer

- Prima BioMed Ltd said its experimental lead treatment improved survival in some ovarian cancer patients without the disease worsening.

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