Neuroprotexeon Receives European Medicines Agency (EMA) Approval of Phase IIIXePOHCAS Clinical Trial Protocol
December 2016. NeuroportoteXeon received the European Medicines Agency (EMA) approval of their Phase III clinical trial protocol XePOHCAS, a prospective, randomized, multicenter interventional trial in critical care adult subjects who experienced out-of-hospital cardiac arrest (OHCA). The Phase III study will compare treatment with the post cardiac-arrest standard-of-care (SOC), which is the administration of targeted temperature management (TTM) in the intensive-care unit (ICU), to SOC plus xenon by inhalation. The approval is a results of months of highly positive interactions with the EMA’s Scientific Advice Working Party (SAWP), the standing working party with the sole remit of providing scientific advice and protocol assistance.
NeuroproteXeon Receives FDA Approval of its Phase III Clinical Trial Protocol
The FDA completed a special protocol assessment (SPA) review of the Phase III Clinical Trial “Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest (XePOHCAS)” and agreed that the design and planned analysis addresses the objectives necessary to support a regulatory submission [NDA- New Drug Application].
NeuroproteXeon Receives Approval from the Compressed Gas Association (CGA) for a Dedicated Medical Xenon Gas Pin Index (CGA 971)
In June 2016, NeuroproteXeon received approval from the Compressed Gas Association (CGA) for a dedicated medical Xenon gas pin index (CGA 971). The new pin index will provide the added safety benefit of ensuring that only medical grade Xenon will be used on all future NeuroproteXeon delivery devices.
NeuroproteXeon Receives ISO 13485 Certifications for their Medical Device Quality Management System
In June 2016 NeuroproteXeon received the internationally recognized ISO 13485:2003 & EN ISO 13485:2012 certification by BSI (British Standard Institution) in recognition of the Quality Management Systems in design, development, control of manufacture and distribution of Xenon gas delivery devices indicated for neuroprotection following neurologic injury resultant from cardiac arrest, including provision of Xenon gas
March 15, 2016
NeuroproteXeon Announces Publication of a Xenon Study to Lessen Cerebral Damage Following Out-of-Hospital Cardiac Arrest in JAMA
Orchard Park, NY, Mar. 15, 2016 (GLOBAL NEWSLINE) – NeuroproteXeon, Inc announced the publication of a Phase II clinical study of inhaled xenon and oxygen for neuroprotection in out-of-hospital cardiac arrest (OHCA) patients. The study, which was undertaken at two University Hospitals in Finland, appears in the March 15 issue of the Journal of the American Medical Association (JAMA).
The study reported on a randomized, controlled trial of 110 successfully resuscitated, but still comatose, victims of OHCA. It compared the efficacy of the xenon/oxygen mixture combined with hypothermia with hypothermia alone over 24 hours. The primary outcome of the trial showed the xenon/oxygen group suffered significantly less (p=.006) white matter brain damage, assessed by Magnetic Resonance Imaging (MRI), than the group receiving hypothermia alone.
According to Mervyn Maze, MB, ChB, one of the inventors of the technology and The William K. Hamilton Distinguished Professor of Anesthesiology at University of California San Francisco, “Overall, the present prognosis for cardiac arrest patients is abysmal with less than 10% of patients surviving to discharge. However, the neuroprotective properties of xenon that were demonstrated in this Phase II trial are encouraging. The vast majority of deaths in cardiac arrest patients are due to neurologic damage.”
The Phase II study was not statistically powered to show a difference in the secondary endpoint of survival. However, the six month mortality rate in the xenon/oxygen group was 27.3% in the xenon group and 34.5% in the control group (adjusted hazard ratio, 0.49 [95% CI, 0.23-1.01]; P= 0.053).
The authors of the trial concluded, “These preliminary findings require further evaluation in an adequately powered clinical trial designed to assess clinical outcomes associated with inhaled xenon among survivors of out-of-hospital cardiac arrest.” To that end, NeuroproteXeon is seeking approval from the United States Food & Drug Administration (“FDA”) to launch a pivotal Phase III OHCA clinical study beginning later this year.
NP Launches “Series A” Funding Round
As NP advances the development of the cardiac arrest program to IND, funding is necessary to achieve the three main targets: toxicology, device development, and clinical trial preparation. To that end, NP has recently launched a Series A Funding Round, which will consist of the issuance of preferred shares in an effort to raise up to $7 million.
Two strategic partners have been identified as leads for this Round with other qualified investors in queue. The goal is to close at a modest increment, $1.75 per Share, to the initial funding round by June 30, 2016.
To learn more about NP, this investment opportunity or receive a term sheet, please contact:
50 Cobham Drive
Orchard Park, NY 14127
NP Appoints Cato Research for Phase III Trials
On January 29th Mervyn Maze, MB, ChB, Chief Medical Officer of NeuroproteXeon announced CATO Research of Durham, North Carolina as the Clinical Research Organization (CRO) administering the Company’s Phase III trial. Dr. Maze indicated the selection reflects CATO’s three decades of experience in international trial administration, their broad international scope, and the ease with which NP and CATO management interacted.
Present plans are for a nine country, approximately 30 sites, 1,300 patent trial, comparing hypothermia with hypothermia plus Xenon. The primary outcome will be survival from cardiac arrest. It is anticipated the trial will be complete in less than two years following FDA/ EMA approval of the Company’s IND application.
CATO commences work with NP immediately. By the end of February, NP’s draft protocol will be expanded and forwarded to the Trial Executive Committee. They will edit the protocol in March and submit it to the FDA for a Special Protocol Assessment later that month. This usually occurs within 45 days of submission. Following agreement with the Agency on trial design, the protocol will be incorporated in our Investigational New Drug Application.
The timing of the protocol assessment dovetails well with drug profiling and device development. The Praxair Drug Master File for cGMP Xenon, which we will reference, will be filed in March.
The tranche of additional toxicology tests requested by FDA will be completed and reported by June. Prototypes of both the clinical test device and consumable breathing circuit/ absorber will be available for validation and verification in mid-March. The devices will be ready for submission in early July.
The plan is anticipated to come together to allow device manufacture, site qualification and training in the fourth quarter and initial patient enrollment in January, 2017.
Adeka Appointed NP’s First International Distributor
Adeka Ilac Sanayi ve Ticaret A.S., one of Turkey’s most successful national pharmaceutical firms, has agreed to an exclusive distribution agreement supporting the registration and sale of NeuroproteXeon products. Over a sixty-year period, Adeka has built one of the finest reputations in the Turkish market.
With almost 80 million people and a highly trained medical community, Turkey is one of the most attractive global markets. Offering over 250 sales representatives, local manufacturing and distribution, plus a concentrated portfolio of critical care products, Adeka is the partner of choice in Turkey. This partnership will also serve as NP’s model as it builds future international relationships.
Following approval of the drug and devices in Turkey, NP will provide Adeka with delivery equipment that will be loaned to local institutions in return for multi-year exclusive agreements to purchase medical Xenon. Adeka will be expected to leverage these systems to penetrate the Turkish market. In order to remain exclusive, Adeka has committed to purchase the product equivalent to 5% of the cardiac arrest market in the first year following approval and at least 25% in year three and thereafter.
Bill Burns, NP CEO, explained the importance of international partnering, “While we plan to sell directly to hospitals in North America and Germanic Europe, this comes with a high level of investment and requires patience for payback. By augmenting this effort with select global partnerships we can generate both profits and cash flow to sustain our business while our direct effort matures.”
Dr. Maze Publishes Two Articles on Xenon
In the first article published in the Canadian Journal of Anesthesia, “Preclinical Neuroprotective Actions of Xenon and Possible Implications for Human Therapeutics: A Narrative Review,” Mervyn Maze, MB, ChB, reviews the literature assessing the efficacy and safety of Xenon in preclinical models of acute ongoing neurologic industry (CJA, Feb 2016, Vol. 63, Issue 2, pp 212-226). He concludes that the neuroprotective effect in preclinical models and the ”safety established in clinical anesthesia set the stage for the launch of randomized clinical trials to determine whether these encouraging neuroprotective findings can be translated into clinical utility.”
In a second editorial published in Anesthesia-Analgesia (the Official Journal of the International Anesthesia Research Society), “Will Xenon Be a Valuable Addition in Perioperative and Critical Care Setting?” Dr. Maze highlights the benefits of Xenon as an anesthetic, most notably the rapidity at which patients emerge from Xenon anesthesia as well as the expected decrease in heart rate while maintaining blood pressure and cardiac index, the latter of which may make it an attractive option for cardiovascular compromised patients. He notes its cost as a general anesthetic has been a limiting factor. He goes on to discuss the neuro-protective properties of Xenon as well as probable applications in the ischemic-reperfusion injury setting.
NP Enters Into a Partnership with Penlon
Continuing in the belief that Xenon is not only a noble gas, but is, moreover, a noble cause, NP is pleased to announce a strategic partnership with Penlon, a world renowned medical device company, which will work hand-in-hand to advance the development and production of the in-hospital adult Xenon delivery device and secure the pathway toward the IND.
Penlon, established in 1943 and headquartered in Abingdon, Oxfordshire UK, was selected to be the contract manufacturer based on the ability to provide valuable components to be incorporated in the device. Penlon’s OEM Division (Original Equipment Manufacturing) is certified to CE and ISO standards, and approved by the CSA and the FDA. Together we look forward to producing a state-of-the-art delivery system consisting of a graphic user interface, electronic control module, suite of monitors, and other critical components.
NP Finds New Home in Orchard Park, New York
NeuroproteXeon has entered into an agreement to lease an office, lab and warehouse space at 50 Cobham Drive in Orchard Park, New York. The space is the former home of MINRAD International and is designed to meet FDA Class II device standards.
The portion of the building NP will be occupying is nearly 19,400 square feet. The largest part of the rental space is a climate-controlled warehouse of approximately 8,000 square feet. This will be used to service the US market for cGMP xenon and the new delivery device beginning with the Phase III clinical trial. Roughly, 4,000 square feet is Class 100,000 rated “clean” space that could be used for pharmaceutical testing or labeling.
In addition, the facility has both a mechanical lab and a traditional wet lab, each with laminar flow hoods. Space for administrative offices covers roughly 4,000 square feet. The initial term of the lease will be through May 2016. Upon successful completion of the venture round (page 4), the Company plans to exercise an option for an additional two years – deadline January 15, 2016. A final option for four additional years must be exercised by December 31, 2017.
At the onset, NP plans for approximately twelve people in the facility. Following completion of the venture round, this is anticipated to increase to around twenty, with 60% of the employees in medical, regulatory, engineering or operations.
NP Selects Global Leader KPMG as Auditor
During the October Board Meeting the Directors appointed KPMG to perform financial assurance services. KPMG is a global network of professional firms providing Audit, Tax and Advisory services, making them one of the Big Four auditing firms.
KPMG delivers a globally consistent set of multidisciplinary services based on deep industry knowledge. Their Life Scienc-es practice group has developed a rich understanding of the market segment required to address industry-specific issues and opportunities. Due to the proximity of NeuroproteXeon’s world-wide headquarters in Orchard Park, New York, it made sense that the Buffalo office of KPMG would provide NP’s audit services.
NeuroproteXeon is planning on an Initial Public Offering (IPO) in the future. The Securities and Exchange Commission (SEC) requires that an S-1 be filed as part of the registration process.
A key component of an S-1 is a set of audited financial statements. This ensures potential investors that financial statements are prepared in accordance with Generally Accepted Accounting Principles (GAAP) and all financial disclosures are presented. The audit process ensures the accuracy, integrity and reliability of the Company’s financial status. The rigorous GAAP process is designed to provide potential shareholders with confidence.
The management team at NeuroproteXeon is excited to work with KPMG as a business partner in this capacity. We believe that KPMG’s global presence is closely aligned with NeuroproteXeon’s international direction. KPMG’s industry knowledge will support investor confidence by ensuring that all financial disclosures are made with the highest level of accuracy and integrity.
NP Inks Exclusive Agreement for Longterm Supply of Xenon
NP entered into a twelve year exclusive contract with two five year renewal periods with Praxair Distribution, Inc. for pharmaceutical grade xenon (“cGMP xenon”). Under the agreement, Praxair (NYSE:PX) will file a Drug Master File (“DMF”) with the FDA, the EMA, and other regulatory agencies in support of NP drug/device filings. Praxair will also provide the xenon for the Phase III clinical trials and primate studies on AIDN.
Praxair is the largest industrial gas company in the Western Hemisphere and a significant participant in other global markets. It will be the second company to produce pharmaceutical grade xenon and the first in North America.
Praxair is already a developer and producer of pharmaceutical grade inhalant drugs. Xenon will add to this portfolio.
Xenon is truly a rare gas. In nature it occurs less than 9 parts per billion and is extracted from the atmosphere in multiple cryogenic separations. To meet drug specifications it is further purified and packaged in a pharmaceutical facility with appropriate environmental and quality controls.
Initial plans are to supply all xenon for the Phase III trial from a single site in North America. Following drug approval and market launch, both companies will monitor drug acceptance and the need for additional locations in North America or Europe.
The roots of this partnership were through local industry affiliations in each company. NP is headquartered in Orchard Park, New York, a southern suburb of Buffalo. Praxair research group of 1000 is headquartered in Tonawanda, New York, a northern suburb of Buffalo. Management of each company is active in the commercial and research aspects of the local health care industry association. The mutual familiarity triggered this unique opportunity.
May 18, 2015
FDA Awards NP Orphan Drug Status for Xenon in Cardiac Arrest
On May 18, the United States Food & Drug Administration (“FDA”) awarded NP Orphan Drug Designation for the use of xenon in Cardiac Arrest (“CA”). The FDA recognized that out-of-hospital CA patients who survive treatment in the hospital are a notably small population. Even when combined with in-hospital CA patients also eligible for treatment, statistics indicate that efforts to increase patient survival to discharge and/ or improve patient neurologic outcome require important advances in care for this disadvantaged patient group.
Orphan Drug Designation has several benefits. The most important of these for NP relates to the period of FDA drug exclusivity for a successful New Drug Application (“NDA”). If approved by the FDA, Xenon for CA will receive seven years of government mandated exclusivity compared to five years for a standard new entity NDA.
NP has filed a similar orphan application with the European Medicines Agency (“EMA”). Their review is anticipated to occur in September.