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Posted On: 10/05/2021 7:15:22 PM
Post# of 148899
Sean,
I am struggling from my phone to upload Dr Recknor’s statement in support of the Cytodyn suit against Amarex.
With my mistake this morning in mind, here is the text from Dr Recknor’s statement:
“Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 1 of 9
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND
CYTODYN, INC. ) )
Plaintiff,
) Civil Action No. 21-2533
) v. ) ) ) AMAREX CLINICAL RESEARCH, LLC, ) and NSF INTERNATIONAL, INC. ) ) ) Defendants. )
DECLARATION OF DR. CHRISTOPHER P. RECKNOR, M.D. IN SUPPORT OF MOTION FOR PRELIMINARY INJUNCTION
I, Dr. Christopher P. Recknor, M.D., declare under penalty of perjury pursuant to 28 U.S.C. § 1746 that the following is true and correct:
1. I am the Chief Operating Officer of CytoDyn, Inc. I was previously the Vice President of Clinical Research at CytoDyn, and have extensive knowledge of CytoDyn’s research and development activities and its relationship with Amarex Clinical Research, LLC.
2. In both roles, I have overseen CytoDyn’s development of leronlimab—a potentially lifesaving drug with application to multiple diseases, including HIV, cancer, liver disease and COVID-19.
3. CytoDyn is a biotech company focused on the clinical development of leronlimab, an investigational drug being studied as a treatment for HIV, cancer, COVID-19, and other serious diseases.
1
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 2 of 9
4. In order to seek FDA approval for leronlimab, CytoDyn has sponsored 22 clinical trials, where the drug is being tested for safety and efficacy.
5. There are currently five trials in which patients are receiving leronlimab: three studies of HIV with 67 patients receiving the drug in all, and one study of non-alcoholic steatohepatitis (NASH, a liver condition) with 25 patients receiving the drug.
6. CytoDyn engaged Amarex to manage the clinical trials of leronlimab, as its contract research organization (CRO).
7. CROs are clinical research specialists with extensive experience conducting clinical trials and complex medical testing and navigating the FDA regulatory process.
8. Amarex and CytoDyn have each signed over 70 project work orders obligating Amarex to conduct clinical trial management on all but two of CytoDyn’s studies.
9. In addition to the Project Work Orders, the parties also signed a Monitoring Plan for each study.
10. The Monitoring Plans expressly required Amarex to conduct safety and other monitoring for the clinical trials.
11. One of the main things Amarex did for each clinical trial was maintain CytoDyn’s data.
12. The dynamic data used and collected in a clinical trial is maintained, by a process of collection and ongoing quality control, in a database known as the “electronic data capture” or the “EDC.”
13. This EDC database includes all data collected on patients enrolled in the studies.
2
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 3 of 9
14. In the HIV studies for example, the data includes patient demographics, medical history, vital signs, electrocardiogram data, biochemistry, coagulation tests, urinalysis, adverse events, concomitant medications, treatment data, survival follow-up, and death information.
15. The EDC database has significant patient safety implications.
16. The EDC database is used to track adverse events and ensure proper adverse event
reporting to the FDA.
17. The change log, or audit trail, for data entered into or modified in the EDC database is an integral component of the clinical data, without which CytoDyn cannot submit certain of the data in support of applications to the FDA.
18. The EDC database is also the means by which the sponsor—CytoDyn—can verify that the study is being conducted in accordance with the study protocol, including that study participants are included or excluded properly, and that data entry is being performed correctly at the trial sites.
19. Pursuant to work orders under the MSA, Amarex programmed and maintained, at CytoDyn’s expense, the EDC for each study.
20. Amarex has failed to provide CytoDyn with requested information for work it claims it has performed.
21. One of the ways CytoDyn has confirmed that Amarex is not performing under the MSA and the Work Orders is by downloading a snapshot of the clinical data for certain clinical trials managed by Amarex.
22. This snapshot is incomplete: it does not include the definitions of the EDC fields (i.e., the database’s “column headings”), the audit trails showing each time the data has been modified, the auto-generated “data queries” that are essential to cleaning and maintaining the
3
26.
27. to the data 28.
study data, 29.
back.
30. of the data 31. 32.
CytoDyn stands ready to take on responsibility for monitoring the ongoing trials.
In order to manage the ongoing clinical trials, however, CytoDyn needs full access from the clinical trials, including the EDC database.
CytoDyn has repeatedly requested that Amarex give it access to its own EDCs and but Amarex has refused.
CytoDyn cannot wait until the resolution of the arbitration to get its EDCs and data
Every day that Amarex holds the data hostage, patients are at risk and the integrity is compromised.
The EDC database is required to monitor the safety of the clinical studies.
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 4 of 9
clinical data, or many other of the essential components of the clinical data that can only be obtained through full access to the EDC.
23. The snapshot was not provided by Amarex, but obtained through CytoDyn’s limited access to the EDCs for certain clinical trials. Even this limited access has now been cut off by Amarex, making it impossible for CytoDyn to obtain additional snapshots.
24. It is impossible for CytoDyn to monitor the ongoing trials or to submit applications to the FDA based on the data contained in the snapshots.
25. However, these limited snapshots are enough for CytoDyn to confirm that the clinical data for multiple studies is in disarray, and has not been maintained by Amarex as the parties’ agreements require.
The EDC database is used to track adverse events and ensure proper adverse event reporting to the FDA.
4
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 5 of 9
33. The EDC database is also the means by which the sponsor—CytoDyn—can verify that the study is being conducted in accordance with the study protocol, including that study participants are included or excluded from the study based on the correct criteria, and that data entry is being performed correctly at the trial sites.
34. The EDC for each trial is built to conform to the data requirements of the study protocol.
35. Pursuant to work orders under the MSA, Amarex programmed and maintained, at CytoDyn’s expense, the EDC for each study.
36. On August 2, 2021, and again on August 3, 2021, CytoDyn demanded that Amarex make its facilities available (for a virtual or in person) audit under the MSA.
37. CytoDyn believed this audit was necessary to determine what else Amarex was failing to do and to protect the integrity of its clinical trial programs.
38. On August 9, 2021, Amarex refused to consent to the audit. Amarex refused to cooperate, first citing Covid-19 restrictions and then—when the auditor made clear that the audit could be conducted safely and in accordance with Covid-safe protocols—pointing to CytoDyn’s alleged nonpayment.
39. Amarex has no right to such data, which it possesses only by virtue of its contractual relationship with CytoDyn.
40. CytoDyn is not asking Amarex to turn over “the results of data analysis” of any kind. Rather, CytoDyn is only asking for Amarex to turn over CytoDyn’s EDCs and data.
41. Amarex has refused—and continues to refuse—to return CytoDyn’s proprietary EDCs and data despite CytoDyn’s repeated requests.
42. Cooperating with an audit is not a “service” under the MSA and Work Orders. 5
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 6 of 9
43. CytoDyn has repeatedly attempted to exercise its audit rights under the MSA, while Amarex has repeatedly refused.
44. CytoDyn is the rightful owner of the clinical data, including the EDCs themselves.
45. CytoDyn has revoked its permission for Amarex to possess the clinical data and the EDCs, but Amarex has nevertheless refused to return them to CytoDyn.
46. Amarex is also retaining CytoDyns’s property longer than CytoDyn, as its rightful possessor, permits.
47. CytoDyn is entitled to rightful possession of its EDCs, clinical data, and Client Materials as defined by Section 5.2 of the MSA
48. Amarex’s plan to discontinue medical and safety monitoring of CytoDyn’s trials without turning over CytoDyn’s EDCs and data will cause immediate and irreparable harm to CytoDyn.
49. Without the EDCs and data, CytoDyn cannot take over management and safety monitoring for the studies before the deadlines imposed by Amarex..
50. This means that the studies will experience a gap in monitoring and may not be useable for FDA approval.
51. This will cause irreparable harm to both CytoDyn and its patients.
52. The dozens of patients in CytoDyn’s clinical trials today will be put at risk by
Amarex’s actions.
53. CytoDyn will either have to immediately stop the trials, so that the patients will lose access to the drug, or the trials will continue without the necessary management and monitoring that CytoDyn cannot provide without full access to the EDCs and clinical data.
6
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 7 of 9
54. CytoDyn merely requests that Amarex comply with its contractual obligation to turn over the EDCs and data.
55. There is no burden on Amarex to provide CytoDyn with access to its EDCs and data.
56. Amarex simply must provide CytoDyn with a username and password to access OpenClinica, the web-based software that contains the EDCs and data.
57. If there is some administrative cost associated with providing CytoDyn access to its EDCs and data (such as a fee to create a new administrative user account, or a hosting fee for maintaining storage of the data), CytoDyn is willing to pay that necessary administrative cost, as contemplated by the MSA.
58. Amarex’s unlawful retention of CytoDyn’s EDCs and data places patients receiving CytoDyn’s experimental treatments at risk, and potentially compromises ongoing research and treatments.
59. Across the nation, patients with life threatening diseases have been, and are being, treated with leronlimab.
60. Without full access to its EDCs and data, CytoDyn cannot ensure that trial sites are able to timely communicate any significant adverse safety event for proper reporting to the FDA. The delays and lack of audit trail associated with implementing a new system for adverse event reporting will put patients at risk and interfere with CytoDyn’s ability to comply with FDA regulations.
61. Under FDA regulations, “significant adverse events”—i.e., serious symptoms that may be side effects of the trial drug—must be reported to the trial monitor within 24 hours.
62. Trial sites put the information about adverse events into the EDC database. 7
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 8 of 9
63. The CRO or Sponsor then reviews that information to report it to the FDA.
64. Without access to the EDC database, CytoDyn will be limited in its ability to see
or identify any adverse event information that is reported by doctors, and reporting will have to be moved to unfamiliar channels, such as email or fax, that will introduce additional risk of errors.
65. If adverse events are not tracked in an EDC, CytoDyn will lose the capability to readily identify trends and correlations in the adverse event data, which could suggest safety issues with the drug.
66. This means adverse event reports to the FDA could be delayed or not identified.
67. This is why it is crucial that Amarex provide CytoDyn with the EDC database so
that it can properly monitor the studies.
68. The EDC database is also necessary for CytoDyn to ensure that the study protocols are being followed.
69. A study sponsor—either itself or through a CRO—must monitor the clinical trial for compliance.
70. The EDC is used to monitor compliance: for example, if a patient begins taking a concomitant medication that may interfere with the trial, that patient may need to be excluded from the study.
71. In an emergency situation, it may even be necessary to “unblind” a study participant to determine whether the participant has received leronlimab or a placebo.
72. This can be critically important because doctors may treat a medical emergency differently depending on whether it could be caused by the investigational drug.
73. But without access to the EDC and a related software system called WebView, which Amarex is also shutting down,, CytoDyn cannot unblind study participants and cannot track
8
their progress through the study, which may be necessary to see whether the participant reported symptoms or had vital sign variations that may assist doctors in responding to the medical emergency.
74. The 67 HIV patients currently receiving leronlimab in CytoDyn’s clinical trials have limited or no other treatment options.
75. 24 of the HIV patients are enrolled in CytoDyn’s trials specifically because their HIV is “treatment-resistant,” meaning it has developed a resistance to up to three known classes of treatments for HIV.
76. To withdraw leronlimab from these patients now—in the middle of the study, before the treatment’s safety and efficacy can be properly assessed—would cause an avoidable loss of all the effort and investment, by both CytoDyn and the patients, in the studies to date.
77. To the extent leronlimab may be ameliorating the patients’ symptoms or even extending their lives, early termination is an avoidable tragedy.
Dated: Oct. 4, 2021 _____________________________ Dr. Christopher P. Recknor, M.D.
272732608
9
- 2?J
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 9 of 9
I am struggling from my phone to upload Dr Recknor’s statement in support of the Cytodyn suit against Amarex.
With my mistake this morning in mind, here is the text from Dr Recknor’s statement:
“Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 1 of 9
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND
CYTODYN, INC. ) )
Plaintiff,
) Civil Action No. 21-2533
) v. ) ) ) AMAREX CLINICAL RESEARCH, LLC, ) and NSF INTERNATIONAL, INC. ) ) ) Defendants. )
DECLARATION OF DR. CHRISTOPHER P. RECKNOR, M.D. IN SUPPORT OF MOTION FOR PRELIMINARY INJUNCTION
I, Dr. Christopher P. Recknor, M.D., declare under penalty of perjury pursuant to 28 U.S.C. § 1746 that the following is true and correct:
1. I am the Chief Operating Officer of CytoDyn, Inc. I was previously the Vice President of Clinical Research at CytoDyn, and have extensive knowledge of CytoDyn’s research and development activities and its relationship with Amarex Clinical Research, LLC.
2. In both roles, I have overseen CytoDyn’s development of leronlimab—a potentially lifesaving drug with application to multiple diseases, including HIV, cancer, liver disease and COVID-19.
3. CytoDyn is a biotech company focused on the clinical development of leronlimab, an investigational drug being studied as a treatment for HIV, cancer, COVID-19, and other serious diseases.
1
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 2 of 9
4. In order to seek FDA approval for leronlimab, CytoDyn has sponsored 22 clinical trials, where the drug is being tested for safety and efficacy.
5. There are currently five trials in which patients are receiving leronlimab: three studies of HIV with 67 patients receiving the drug in all, and one study of non-alcoholic steatohepatitis (NASH, a liver condition) with 25 patients receiving the drug.
6. CytoDyn engaged Amarex to manage the clinical trials of leronlimab, as its contract research organization (CRO).
7. CROs are clinical research specialists with extensive experience conducting clinical trials and complex medical testing and navigating the FDA regulatory process.
8. Amarex and CytoDyn have each signed over 70 project work orders obligating Amarex to conduct clinical trial management on all but two of CytoDyn’s studies.
9. In addition to the Project Work Orders, the parties also signed a Monitoring Plan for each study.
10. The Monitoring Plans expressly required Amarex to conduct safety and other monitoring for the clinical trials.
11. One of the main things Amarex did for each clinical trial was maintain CytoDyn’s data.
12. The dynamic data used and collected in a clinical trial is maintained, by a process of collection and ongoing quality control, in a database known as the “electronic data capture” or the “EDC.”
13. This EDC database includes all data collected on patients enrolled in the studies.
2
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 3 of 9
14. In the HIV studies for example, the data includes patient demographics, medical history, vital signs, electrocardiogram data, biochemistry, coagulation tests, urinalysis, adverse events, concomitant medications, treatment data, survival follow-up, and death information.
15. The EDC database has significant patient safety implications.
16. The EDC database is used to track adverse events and ensure proper adverse event
reporting to the FDA.
17. The change log, or audit trail, for data entered into or modified in the EDC database is an integral component of the clinical data, without which CytoDyn cannot submit certain of the data in support of applications to the FDA.
18. The EDC database is also the means by which the sponsor—CytoDyn—can verify that the study is being conducted in accordance with the study protocol, including that study participants are included or excluded properly, and that data entry is being performed correctly at the trial sites.
19. Pursuant to work orders under the MSA, Amarex programmed and maintained, at CytoDyn’s expense, the EDC for each study.
20. Amarex has failed to provide CytoDyn with requested information for work it claims it has performed.
21. One of the ways CytoDyn has confirmed that Amarex is not performing under the MSA and the Work Orders is by downloading a snapshot of the clinical data for certain clinical trials managed by Amarex.
22. This snapshot is incomplete: it does not include the definitions of the EDC fields (i.e., the database’s “column headings”), the audit trails showing each time the data has been modified, the auto-generated “data queries” that are essential to cleaning and maintaining the
3
26.
27. to the data 28.
study data, 29.
back.
30. of the data 31. 32.
CytoDyn stands ready to take on responsibility for monitoring the ongoing trials.
In order to manage the ongoing clinical trials, however, CytoDyn needs full access from the clinical trials, including the EDC database.
CytoDyn has repeatedly requested that Amarex give it access to its own EDCs and but Amarex has refused.
CytoDyn cannot wait until the resolution of the arbitration to get its EDCs and data
Every day that Amarex holds the data hostage, patients are at risk and the integrity is compromised.
The EDC database is required to monitor the safety of the clinical studies.
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 4 of 9
clinical data, or many other of the essential components of the clinical data that can only be obtained through full access to the EDC.
23. The snapshot was not provided by Amarex, but obtained through CytoDyn’s limited access to the EDCs for certain clinical trials. Even this limited access has now been cut off by Amarex, making it impossible for CytoDyn to obtain additional snapshots.
24. It is impossible for CytoDyn to monitor the ongoing trials or to submit applications to the FDA based on the data contained in the snapshots.
25. However, these limited snapshots are enough for CytoDyn to confirm that the clinical data for multiple studies is in disarray, and has not been maintained by Amarex as the parties’ agreements require.
The EDC database is used to track adverse events and ensure proper adverse event reporting to the FDA.
4
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 5 of 9
33. The EDC database is also the means by which the sponsor—CytoDyn—can verify that the study is being conducted in accordance with the study protocol, including that study participants are included or excluded from the study based on the correct criteria, and that data entry is being performed correctly at the trial sites.
34. The EDC for each trial is built to conform to the data requirements of the study protocol.
35. Pursuant to work orders under the MSA, Amarex programmed and maintained, at CytoDyn’s expense, the EDC for each study.
36. On August 2, 2021, and again on August 3, 2021, CytoDyn demanded that Amarex make its facilities available (for a virtual or in person) audit under the MSA.
37. CytoDyn believed this audit was necessary to determine what else Amarex was failing to do and to protect the integrity of its clinical trial programs.
38. On August 9, 2021, Amarex refused to consent to the audit. Amarex refused to cooperate, first citing Covid-19 restrictions and then—when the auditor made clear that the audit could be conducted safely and in accordance with Covid-safe protocols—pointing to CytoDyn’s alleged nonpayment.
39. Amarex has no right to such data, which it possesses only by virtue of its contractual relationship with CytoDyn.
40. CytoDyn is not asking Amarex to turn over “the results of data analysis” of any kind. Rather, CytoDyn is only asking for Amarex to turn over CytoDyn’s EDCs and data.
41. Amarex has refused—and continues to refuse—to return CytoDyn’s proprietary EDCs and data despite CytoDyn’s repeated requests.
42. Cooperating with an audit is not a “service” under the MSA and Work Orders. 5
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 6 of 9
43. CytoDyn has repeatedly attempted to exercise its audit rights under the MSA, while Amarex has repeatedly refused.
44. CytoDyn is the rightful owner of the clinical data, including the EDCs themselves.
45. CytoDyn has revoked its permission for Amarex to possess the clinical data and the EDCs, but Amarex has nevertheless refused to return them to CytoDyn.
46. Amarex is also retaining CytoDyns’s property longer than CytoDyn, as its rightful possessor, permits.
47. CytoDyn is entitled to rightful possession of its EDCs, clinical data, and Client Materials as defined by Section 5.2 of the MSA
48. Amarex’s plan to discontinue medical and safety monitoring of CytoDyn’s trials without turning over CytoDyn’s EDCs and data will cause immediate and irreparable harm to CytoDyn.
49. Without the EDCs and data, CytoDyn cannot take over management and safety monitoring for the studies before the deadlines imposed by Amarex..
50. This means that the studies will experience a gap in monitoring and may not be useable for FDA approval.
51. This will cause irreparable harm to both CytoDyn and its patients.
52. The dozens of patients in CytoDyn’s clinical trials today will be put at risk by
Amarex’s actions.
53. CytoDyn will either have to immediately stop the trials, so that the patients will lose access to the drug, or the trials will continue without the necessary management and monitoring that CytoDyn cannot provide without full access to the EDCs and clinical data.
6
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 7 of 9
54. CytoDyn merely requests that Amarex comply with its contractual obligation to turn over the EDCs and data.
55. There is no burden on Amarex to provide CytoDyn with access to its EDCs and data.
56. Amarex simply must provide CytoDyn with a username and password to access OpenClinica, the web-based software that contains the EDCs and data.
57. If there is some administrative cost associated with providing CytoDyn access to its EDCs and data (such as a fee to create a new administrative user account, or a hosting fee for maintaining storage of the data), CytoDyn is willing to pay that necessary administrative cost, as contemplated by the MSA.
58. Amarex’s unlawful retention of CytoDyn’s EDCs and data places patients receiving CytoDyn’s experimental treatments at risk, and potentially compromises ongoing research and treatments.
59. Across the nation, patients with life threatening diseases have been, and are being, treated with leronlimab.
60. Without full access to its EDCs and data, CytoDyn cannot ensure that trial sites are able to timely communicate any significant adverse safety event for proper reporting to the FDA. The delays and lack of audit trail associated with implementing a new system for adverse event reporting will put patients at risk and interfere with CytoDyn’s ability to comply with FDA regulations.
61. Under FDA regulations, “significant adverse events”—i.e., serious symptoms that may be side effects of the trial drug—must be reported to the trial monitor within 24 hours.
62. Trial sites put the information about adverse events into the EDC database. 7
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 8 of 9
63. The CRO or Sponsor then reviews that information to report it to the FDA.
64. Without access to the EDC database, CytoDyn will be limited in its ability to see
or identify any adverse event information that is reported by doctors, and reporting will have to be moved to unfamiliar channels, such as email or fax, that will introduce additional risk of errors.
65. If adverse events are not tracked in an EDC, CytoDyn will lose the capability to readily identify trends and correlations in the adverse event data, which could suggest safety issues with the drug.
66. This means adverse event reports to the FDA could be delayed or not identified.
67. This is why it is crucial that Amarex provide CytoDyn with the EDC database so
that it can properly monitor the studies.
68. The EDC database is also necessary for CytoDyn to ensure that the study protocols are being followed.
69. A study sponsor—either itself or through a CRO—must monitor the clinical trial for compliance.
70. The EDC is used to monitor compliance: for example, if a patient begins taking a concomitant medication that may interfere with the trial, that patient may need to be excluded from the study.
71. In an emergency situation, it may even be necessary to “unblind” a study participant to determine whether the participant has received leronlimab or a placebo.
72. This can be critically important because doctors may treat a medical emergency differently depending on whether it could be caused by the investigational drug.
73. But without access to the EDC and a related software system called WebView, which Amarex is also shutting down,, CytoDyn cannot unblind study participants and cannot track
8
their progress through the study, which may be necessary to see whether the participant reported symptoms or had vital sign variations that may assist doctors in responding to the medical emergency.
74. The 67 HIV patients currently receiving leronlimab in CytoDyn’s clinical trials have limited or no other treatment options.
75. 24 of the HIV patients are enrolled in CytoDyn’s trials specifically because their HIV is “treatment-resistant,” meaning it has developed a resistance to up to three known classes of treatments for HIV.
76. To withdraw leronlimab from these patients now—in the middle of the study, before the treatment’s safety and efficacy can be properly assessed—would cause an avoidable loss of all the effort and investment, by both CytoDyn and the patients, in the studies to date.
77. To the extent leronlimab may be ameliorating the patients’ symptoms or even extending their lives, early termination is an avoidable tragedy.
Dated: Oct. 4, 2021 _____________________________ Dr. Christopher P. Recknor, M.D.
272732608
9
- 2?J
Case 8:21-cv-02533-GLS Document 6-3 Filed 10/04/21 Page 9 of 9
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