Thursday, September 01, 2011 10:47:25 AM
8-31-11/Belgium: IBA (Ion Beam Applications) today released its consolidated results for the first half of 2011
http://group.iba-worldwide.com/sites/default/files/pressroom/PR-Results-H1-2011-EN.pdf
Pg5: In the strategic area of the development of new marked molecules, the first half was characterized
by the following developments:
In June 2011, during a joint press conference, IBA and its partner WILEX AG commented on the letter from the FDA following the "Pre-BLA meeting" (preparatory meeting for the introduction of the application for marketing authorization of a pharmaceutical product) for REDECTANE®. In summary, to enable WILEX & IBA to strengthen their case for launching the product on the market, the FDA suggested that an "outcome study" be carried out (study involving the use of the product in the doctor's decision making process). WILEX & IBA both agreed that it is quite logical that this outcome study follows the phase III study, finalized to date. However they suggested that this outcome study should be made during a phase IV trial, i.e. after introduction of the product on the market. Discussions are ongoing with the FDA about this. The FDA also discussed manufacturing process issues and requested that the 3rd lot of the antibody Girentuximab being produced on site at Avid Bioservices, Inc., (Tustin, CA) and be made an integral part of the filing (and not submitted in the course of the approval process as hoped) and also requested additional information on the product characterization and the validation processes by IBA, responsible for the marking of the antibodies. It is important to remember that the phase 3 trial of on the product showed that the PET/CT associated with REDECTANE® leads to a much better diagnosis than with the CT alone. Currently, IBA continues to adapt its installations in order to enable the product to be launched in the U.S. and then the rest of the world once authorizations for market release have been received. The next meeting with the FDA on this matter is being prepared. It will focus on the proposed new protocol for further clinical trials designed in collaboration with the Medical
Advisory Board.
http://group.iba-worldwide.com/sites/default/files/pressroom/PR-Results-H1-2011-EN.pdf
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The drug candidate REDECTANE (INN: 124I-Girentuximab) is based on an antibody and is being developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer. REDECTANE is the radioactively labelled form of the antibody Girentuximab. The labelled antibody WX-G250 targets clear cell renal cell carcinoma and accumulates in the tumour tissue. This accumulation can be visualised by means of positron emission tomography (PET). A proof-of-concept study with REDECTANE was successfully conducted. It was shown that REDECTANE could predict clear cell RCC with a specificity of 100% and a sensitivity of 94%. This means that the correct diagnosis with REDECTANE that clear cell renal cell cancer is not present were confirmed by subsequent histology in 100% (specificity). The correct diagnosis of clear cell renal cell cancer was confirmed in 94% of cases (sensitivity). The Company is not aware of any other available imaging technique with comparable specificity and sensitivity. The study was carried out by the cooperation partner of WILEX, the Ludwig Institute for Cancer Research, New York in collaboration with the Memorial Sloane-Kettering Cancer Center, NY. REDECTANE could determine whether the patient had clear cell renal cell carcinoma before surgery and the subsequent pathology. Therefore, REDECTANE could significantly improve and simplify treatment planning for patients suspected of having renal cancer.
http://www.wilex.de/portfolio-english/redectane/overview-redectane
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SPECIFIC PROTOCOL ASSESSMENT
WILEX has received a Special Protocol Assessment (SPA) from the US FDA for this Phase III registration trial. With this SPA the FDA confirms that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for REDECTANE. The FDA is considered to be bound by this protocol assessment as part of the approval process.
On 17 June 2011, WILEX and its partner IBA released information on the pre-BLA meeting with the FDA and the next steps in the approval process for REDECTANE®. Pre-BLA meetings serve to discuss the application for approval of a product and the approval process in advance of filing. The FDA confirmed during the discussions at this meeting that the Phase III REDECT trial delivers reasonable evidence of the diagnostic efficacy and safety of REDECTANE®. Two issues remain to be resolved by WILEX and its partner IBA. The FDA suggested that WILEX & IBA might consider an outcomes based study to provide additional evidence of clinical benefit before BLA filing. WILEX & IBA agree with the FDA that a trial with a clinical benefit outcome could represent the next logical step in REDECTANE’s development. WILEX, IBA and external medical advisors however are of the opinion that such a trial should be conducted as a Phase IV trial after market approval. WILEX & IBA will first discuss the trial design and strategy with the Medical Advisory Board and subsequently with the FDA. The second set of issues discussed with the FDA concerns matters related to the manufacturing of REDECTANE®. WILEX & IBA will make the required data available to the FDA in the next months.
http://www.wilex.de/portfolio-english/redectane/phase-iii-registration-trial
6-20-11: ”IBA, Wilex Meet FDA on Redectane Trial”
By AuntMinnieEurope.com (Molecular Imaging) staff writers
Radiopharmaceutical developer Ion Beam Applications (IBA) [ http://www.iba-worldwide.com ] and drug company Wilex [ http://www.wilex.de/index.htm ] recently met with the U.S. FDA to discuss the regulatory review process for IBA's Redectane PET/CT radiopharmaceutical. IBA & Wilex recently completed the phase III REDECT trial to determine whether the combination of the radiolabeled antibody Redectane with PET and CT could improve the diagnosis of renal masses, compared with the use of CT alone. The trial achieved its primary end point, indicating that PET/CT with Redectane correctly diagnosed the presence of clear cell renal cell cancer with a sensitivity of 86% and sensitivity of 87%, findings that reached statistical significance, according to IBA. The FDA confirmed that the trial provides reasonable evidence for the diagnostic efficacy and safety of Redectane, but suggested that IBA and Wilex consider an additional outcomes-based study to provide evidence of clinical benefit before submitting a biologics license application (BLA). IBA and Wilex, however, would prefer that such a study be conducted as a phase IV trial after Redectane reaches market. IBA said that it would discuss the issue with its medical advisory board and then the FDA, and then make an announcement regarding its regulatory plan. The companies and the agency also discussed concerns regarding the manufacturing of Redectane. Wilex has completed 2 consecutive lots for process validation of the antibody girentuximab at Avid Bioservices. The 3rd production run was started before the meeting and is expected to be completed soon. In addition, the FDA has requested from IBA data pertaining to the commercial production of Redectane: in particular, product characterization and process validation.
http://www.auntminnieeurope.com/index.aspx?sec=sup&sub=mol&pag=dis&ItemId=605212
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