If there was ever a time to ask a question and get a answer now that they need your voting support you might get one so send it off to them..
Question along the lines - back in 2016 what was discovered to be the real cause of the CO2 in prefilled syringes? Did further batches have to be manufactured and validated? etc
Background from my old notes that had a unanswered red flag at the time.
There was testing and if you remember a failure as well. They changed from large scale manufacturer in Europe to small scale in USA for contract production. I looked back at my notes from the time.
There are processes in place to prevent wrong compounds at every stage of production and then testing post production and stringent FDA protocols to be completed and certified by outside labs. . Were the products 100% same? Was a direct comparison done and proof that compound was viable for both new and old production sources and of the concentrated and diluted version?
The failure had a odd explanation that received no comment at the time and never a follow up comment on cause but was a red flag as it didn't make sense to me
So just how can sealed syringes in seal packaging and a outer be affected by a co2 gas in transport coming from warming dry ice packs. ? Permeation into a sealed packaged syringe through one of the individual system components (syringe, needle shield, and plunger) . More than 2 layers of outer packaging a box and and then there shareholders are to believe the prefilled glass/ plastic syringes really not (CO2) gas tight at room pressures? So gas has gone through box, then outer packing , then inner packaging and then through material of syringe be it glass wall plastic wall or plunger or plunger seal or tip seal and affected FTT solution all at normal room temperatures and pressures? Was it at lower pressure on a non pressurised flight or just on normal road transport? That if real as a explanation would affect every syringe manufactured by the underlying manufacturer , their fill and seal procedure and also transport. as CO2 released by dry ice is not at any pressure and CO2 exists in normal air - Didn't ever seem right It took em months in the end
ann 9/9/2016 and no real answer ???
3/10 - no real answer ?
They never confirmed the cause as being CO2 from dry ice transport - production issue??? Avoided mentioning it and just said is fixed and approved for use it?
Question - did they have to redo complete batches? quarterly may help to see if extra cashflow was used on production and ann rpt for any new compound destroyed as opposed to old stock.
If you were to tell me that prior to filling that pre-manufactured syringes were gas flushed or something that would be a bit more believable but how did it differ in the process used in Europe and why didn't FTT tell shareholders ? Always a risk transferring technology and compounds to different manufacturing and filling contractors.
Focus : Manufacturing of Clinical LotsInitiated on the 18th of March
Validation and transfer of materialsfrom Europe to the US (Boston) Establishment of Phase II appropriate(small scale) fill-and-finish process thatis “comparable” to prior large-scale EUmanufacturing. Site qualification / audit Engineering run – successfully completed during the last week of April GMP run to be finished by end-May (standard dose, high dose,placebo) but release assays still to be completed in Europe (ourvalidated assays) post-manufacturing Lot release assays : end-May / early June
Ann 15 /6/ 2016 Brisbane, 15 June, 2016. Factor Therapeutics Limited, ASX:FTT (the “Company”) wishes to provide anupdate to shareholders in relation to proposed timelines for commencement of its Phase II clinical trialin the US. Prior guidance had indicted a target date of end-June 2016, for the submission of outstandingdocumentation to the FDA, including certificates of analysis for the proposed clinical materials to beused in the trial.The Company recently completed a US-based “fill-and-finish” activity to manufacture three batches ofmaterials (low-dose, high-dose, placebo) for this clinical trial. The contract laboratory conducting therelease testing has determined that samples taken from one of the batches is out of specification (OOS).A detailed root-cause analysis has been conducted that links the OOS to a CO2 gas (carbonic acid)contamination of the pre-filled syringes, originating from dry ice cooling used during the shipping of testsamples from the manufacturer to the Company’s contract analytics laboratory. Due to the detailednature of the investigative process, the need to document the root-cause and experimental validation ofa revised shipping protocol to avoid this situation in the future, the company anticipates a delay ofapproximately 4-6 weeks.Factor Therapeutics CEO, Mr Nigel Johnson, said, “This inadvertent and unforeseen contamination ofsamples via the shipping process between manufacturer and test lab was not anticipated, however boththe Factor team and our manufacturing and laboratory partners responded rapidly, enabling us toquickly identify the root cause and modify protocols to ensure this issue is eliminated.”Executive Director, Dr Christian Behrenbruch, said, “Although this delay is unlikely to be material from acost or trial impact perspective, we recognise that shareholders are closely monitoring the Company’sturn-around progress and we wish to keep shareholders fully informed of any potential slippage fromour previously articulated milestone dates.”A final summary of the investigation outcomes and revised timelines will be provided to shareholders inthe Company’s quarterly update at the end of June
Did I miss commentary in June quarterly or newsletter? Quarterly 28/7 had no other papers attached
From Ann rpt releases 17/8/2016 - still in testing
Upon completion of the financing a number of clinical activities were immediately launched to assertively pursue IND approval:• Completed process transfer from Europe to the United States for manufacture of the clinical lots for the Phase IIprogram. Clinical manufacturing was successfully completed by end-July 2016 and at the time of this operationssummary is in final release testing prior to release
Moved to small-scale VF-001 drug product manufacturing to Berkshire Sterile Manufacturing, with logistics provided byAlmac Group. Re-establishing the manufacturing process was complex and disruptive to operations, however theCompany’s management team and vendors were able to successfully establish VF-001 in the US. This milestone wasalso accomplished with active involvement from BPTC experts including valuable input from a former FDA qualityinspector.
Ann 9/9/2016
Completion of ManufacturingBrisbane, 9th of September 2016. Factor Therapeutics Limited (ASX : FTT) is pleased to announce thecompletion of manufacturing of its materials for its US-based Phase II clinical trial of VF-001 for the treatmentof venous leg ulcers. This milestone marks the completion of a major scope of work that has involvedtransitioning operations to the US and manufacturing packaged drug product in conformance with the FDA’srequirements for a biologic drug, at this stage of development.The batch of materials (placebo, standard-dose, high-dose) are currently in the process of being released andthe Investigational New Drug (IND) amendments are being finalized for publication and submission to the FDA,including a significantly revised and improved clinical protocol based on feedback from the Company’s medicaladvisory board. This administrative process will take approximately two weeks to complete.CEO, Nigel Johnson stated:This is a significant milestone for the company and marks the completion of over two years of major effort anda major push in the US the past six months. We are grateful to shareholders for their patience.Executive Director, Christian Behrenbruch stated:In parallel to completing manufacturing, we have launched our clinical trial preparation including start-upactivities with our CRO (Parexel), site qualification and preparation for patient recruitment. Despite earlierreported delays completing release assays, we are making excellent progress towards First-Patient-In for thePhase II study.
ann 3/10/2016
Brisbane, 3rd October, 2016Dear Shareholders,I’m pleased to present you this quarterly update on our progress. It’s been a busy period as we completed our manufacturing activities and prepare to launch our Phase II trial for VF-001 in the US. Our last quarterly update was predominately focused on the logistical aspects of moving our drug product manufacturing from Europe to the US. This has now been successfully concluded.We are approximately a quarter behind schedule. Most of the delay has come as follow-on effect from the “out of specification” result obtained during material testing back in June (ASX Release 15th June 2016). Unfortunately, the resulting investigation, root-cause analysis and rescheduling of GMP testing “slots” pushed material release into the middle of the European summer, with a commensurate pace of completion by 3rd party vendors.Notwithstanding the manufacturing delays and subsequent amendment of our IND, we have forged ahead with clinical trial preparation in parallel and we don’t expect an adverse impact on either our ability to complete the clinical trial or the financial runway of the company per our financing plan. As indicated in our most recent set of annual financial statements, we have considerably reduced our cash burn rate and are employing effective cost control over product development.Although the VF-001 Phase II trial in venous leg ulcers is the major focus both financially and operationally, we have made progress in many other areas that contribute to building the commercial profile of Factor Therapeutics. For example, we continue to evolve our intellectual property portfolio, both in terms of “ever-greening” strategies for our lead program, but also our general IP landscape around vitronectin-targeting growth factors. We have commenced a modest scope of work with our ocular program that should yield an initial set of results over the next 6 months.As we head toward our Annual General Meeting in November, there is ample evidence that we are not the same company that we were a year ago.Thank you for your support and engagement.SincerelyNigel Johnson, CEO
ann 10/10/2016
Submission of IND Amendments for Phase II Study of VF-001 in the USBrisbane, 10th of October, 2016. Factor Therapeutics Limited (ASX : FTT) wishes to inform shareholders that it has filed an amended Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). This amended IND includes complete Certificates of Analysis (CoAs) for materials to be used in the planned Phase II trial, comparability information and a revised clinical protocol, consistent with prior requests and disclosed interaction with the FDA.The submission was made before close-of-business US Eastern time on Friday 7th of October (Sat 8th of October, AEDT). The company is now in a 30-day review process by the FDA.CEO, Nigel Johnson stated:We are pleased to be at this point in the company’s product development journey and we await the decision from the FDA regarding the status of the company’s Clinical Hold.Executive Director, Christian Behrenbruch stated:Our data submission was high quality and we have every reason to believe we submitted a complete and approvable IND submission.
FTT Price at posting:
0.4¢ Sentiment: None Disclosure: Held
