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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 8, 2024
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41488 |
|
82-5089826 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(Address
of principal executive offices) (Zip Code)
(240)
430-4212
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock $0.00001 per share |
|
SHPH |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
1.01 Entry into a Material Definitive Agreement.
On
August 8, 2024, Shuttle Pharmaceuticals, Inc. (“Shuttle Pharma”), a wholly owned subsidiary of Shuttle Pharmaceuticals Holdings,
Inc. (the “Company”), entered into a work order (the “Work Order”) with Theradex Systems, Inc., a New Jersey
contract research organization (“CRO”) for purposes of supporting Shuttle Pharma’s “Phase 2 Study of Ropidoxuridine
as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with Unmethylated MGMT
Promotor.” The Phase 2 clinical trial was previously approved by the U.S. Food and Drug Administration, or the FDA,
in January 2024 and the Institutional Review Board on June 21, 2024. As such, Shuttle Pharma is now in the process
of signing up six clinical sites where the clinical studies will be performed – two of which have completed initial site initiation
visits and one of which is ready to enroll patients – and where the CRO will oversee such studies.
Under
the terms of the Work Order, the CRO will oversee the studies for a period of 53 months (the “Term”), including overseeing
and monitoring the regulatory aspects of the Phase 2 clinical trial, and managing the documentation surrounding the clinical trial in
exchange for a fee of approximately $2.3 million, payable in stages and based upon services performed during the Term of the study. The
underlying terms of the Work Order are governed by a master service agreement, dated November 1, 2018 (the “MSA”), between
Shuttle Pharma and the CRO, which contains standard intellectual property, confidentiality, indemnification and insurance provisions,
ensuring that Shuttle Pharma will own all intellectual property developed from the Phase 2 clinical trial.
The
foregoing description of the Work Order and the MSA do not purport to be complete and are qualified in their entirety by reference to
the full text of such agreement, which are filed herewith as Exhibits 10.1 and 10.2 and are incorporated by reference herein.
Item
8.01 Other Events.
On
August 14, 2024, the Company issued a press release announcing that it had entered into agreements with two of the six planned locations
that will administer the Company’s Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. A
copy of the press release is furnished herewith.
The
information in this Item 8.01 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under that section, and shall not be deemed
to be incorporated by reference into the filings of the Company under the Securities Act or the Exchange Act, regardless of any general
incorporation language in such filings. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any
information of the information contained in this Item 8.01.
Forward-Looking
Statements
This
Current Report on Form 8-K contains “forward-looking statements” within the meaning of Section 21E of the Exchange Act, and
the Private Securities Litigation Reform Act of 1995. Forward-looking statements may relate to statements concerning future results,
strategy and plans of the Company (including certain statements which may be identified by the use of the words “plans,”
“expects,” “does not expect,” “estimated,” “is expected,” “budget,” “scheduled,”
“estimates,” “forecasts,” “intends,” “anticipates,” “does not anticipate”
or “believes,” or variations of such words and phrases, or state that certain actions, events or results “may,”
“could,” “would,” “might,” “projects,” “will,” “will be taken,”
“occur” or “be achieved”). Forward-looking statements are based on the opinions and estimates of management of
the Company, as of the date such statements are made, and they are subject to known and unknown risks, uncertainties, assumptions and
other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied
by such forward-looking statements. Additional information on these and other factors that may cause actual results and the Company’s
performance to differ materially is included in the Company’s periodic reports filed with the Securities and Exchange Commission,
or the SEC. Copies of the Company’s filings with the SEC are available publicly on the SEC’s website at www.sec.gov.
Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. These forward-looking
statements are made only as of the date hereof, and the Company undertakes no obligations to update or revise the forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by law.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No. |
|
Description |
|
|
|
10.1 |
|
Work Order, dated August 8, 2024, between Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc.* |
10.2 |
|
Master Services Agreement, dated November 1, 2018, between Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc. |
99.1 |
|
Press Release dated August 14, 2024. |
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
*certain
portions of this exhibit have been redacted because it (i) is not material and (ii) is the type of information that the company normally
treats as private or confidential.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC. |
|
|
|
Dated:
August 14, 2024 |
|
|
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name: |
Anatoly
Dritschilo |
|
Title: |
Chief
Executive Officer |
Exhibit
10.1
Portions
of this agreement have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. Redactions are indicated with “[***].”
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-1_001.jpg)
Work
Order #3
Theradex
Systems, Inc. (hereinafter “Theradex Oncology”)
to
assist
Shuttle
Pharmaceuticals, Inc. (hereinafter “Shuttle”)
with
the Scope of Work associated with:
Phase
2 Study of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with
Unmethylated MGMT Promoter
30
July 2024
|
Prepared
For: |
Michael
Vander Hoek
VP,
Regulatory
Shuttle
Pharmaceuticals, Inc.
401
Professional Drive
Suite
260
Gaithersburg,
MD 20879 USA
Email:
M.Vanderhoek@shuttlepharma.org |
|
|
|
|
Prepared
By: |
[***]
[***]
The
Pinnacle, Station Way
Crawley
West
Sussex UK
RH10
1JH
Phone:
[***]
Email:
[****] |
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-1_001.jpg)
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Work
Order #3 to the Master Service Agreement dated 01 November 2018 between Shuttle and Theradex Oncology (hereinafter “MSA”),
to
assist Shuttle. with the Scope of Work associated with
“Phase
2 Study of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with
Unmethylated MGMT Promoter”
(hereinafter
“Project”)
This
Work Order details the services that Theradex Oncology shall provide to Shuttle pertaining to the aforementioned Project. Upon signature
by authorized representatives of Theradex Oncology and Shuttle, this Work Order shall be incorporated by reference and made a part of
the MSA between Shuttle and Theradex Oncology.
This
Work Order is effective as of 01 March 2024 and is estimated to be completed by 31 July 2028 (hereinafter “Term”). The Term
of this Work Order may be extended upon the written request of Shuttle and the mutual agreement by Shuttle and Theradex Oncology.
Of
note: the budget, dated 23 July 2024, accompanying this WO is limited in $ amount and time. It will only cover the first year from February
2024 till January 2025 and is limited to US$2,237,544. A Change Order covering subsequent year(s) and increased $ amount will need to
be in place from January 2025 onwards.
The
services under this Work Order shall be conducted under and subject to the terms and conditions of the MSA.
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
ACKNOWLEDGED,
ACCEPTED AND AGREED TO:
Theradex
Oncology: |
|
|
|
|
|
/s/
Margaret Valnoski |
|
08-August-2024 |
Margaret
Valnoski |
|
Date
|
President
/ CEO
|
|
|
Theradex
Systems, Inc. |
|
|
|
|
|
Shuttle |
|
|
|
|
|
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-1_002.jpg) |
|
August
8, 2024 |
|
|
|
Michael
P Vander Hoek |
|
Date |
VP,
Regulatory |
|
|
Shuttle
Pharmaceuticals, Inc. |
|
|
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
General
Terms
A. |
Shuttle
acknowledges that this Work Order does not include any applicable VAT or other tax to which Shuttle may be subject. Such taxes will
be the sole responsibility of Shuttle. |
|
|
B. |
Theradex
will utilize a milestone billing payment schedule for this Project. However, Theradex will submit to Shuttle a monthly invoice detailing
pass-through expenses that are rendered to Shuttle. |
|
|
C. |
Payment
will be made by Shuttle in accordance with the terms stipulated in the Master Service Agreement dated 01 November 2018. |
|
|
D. |
Shuttle
agrees not to employ or seek to employ any Theradex employee for a period of six (6) months following the termination of all contracts
of Shuttle with Theradex, or a period of six (6) months following the departure of the employee from Theradex, whichever is later. |
|
|
E. |
Theradex
will initiate quarterly contract review meetings with Shuttle to monitor the progress of billings and milestone activities. The meetings’
purpose is to 1) determine the level of progress by major service activity by Theradex and 2) ensure activities have remained in
scope to the Work Order and the budget has not, or is not anticipated to exceed, the Work Order. |
|
|
F. |
Theradex
services will be conducted in compliance with Theradex Standard Operating Procedures (SOPs), unless otherwise specified. Should [Shuttle]
require that Theradex conduct certain services in compliance with Shuttle’s SOPs, adjustment of the Study Budget may be necessary. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Theradex
Oncology Project Team
The
Project Team members and their roles are outlined in the Project Management Plan. Appendix 1: Theradex Oncology Scope of Work
Lead-in
Period |
|
5
months |
Enrollment
Period |
|
24
months |
Average
Duration of Patient Treatment |
|
2
months |
Data
Lock |
|
2
months |
Clinical
Study Report |
|
2
months |
Long-Term
Follow Up |
|
18
months |
Total
Study Duration |
|
53
months |
Number
of Countries |
|
1
(US) |
Number
of Sites |
|
6
sites |
Number
of Patients Screened |
|
65
(20% screen failure rate) |
Number
of Patients Enrolled |
|
54 |
Theradex
Oncology services will be conducted in compliance with Theradex Oncology Standard Operating Procedures (SOPs), unless otherwise specified.
Should Shuttle require Theradex Oncology conduct certain services in compliance with Shuttle’s SOPs, adjustment of the Study Budget
may be necessary.
|
|
Timeline |
Task |
|
Estimated
Start Date |
|
Estimated
Completion Date |
Start-up:
Final Protocol to First Patient In (FPI) |
|
01
March 2024 |
|
31
July 2024 |
Recruitment:
FPI to Last Patient In (LPI) |
|
01
August 2024 |
|
01
August 2026 |
Treatment:
LPI to Last Patient Out (LPO) |
|
02
August 2026 |
|
01
October 2026 |
Database
Lock: LPO to Database Lock |
|
02
October 2026 |
|
30
November 2026 |
Final
Report: Draft Report to Final Report |
|
01
December 2026 |
|
31
January 2027 |
Long-Term
Follow Up |
|
01
February 2027 |
|
31
July 2028 |
Total
Timeline |
|
53
months |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
1.3 |
Study Set-up and Initiation |
Task
List |
|
Shuttle |
|
Theradex |
Conduct
Feasibility to identify potential sites |
|
X |
|
|
Recruit
back up sites |
|
X |
|
|
Replace
sites that withdraw |
|
X |
|
|
Collection
of CDAs |
|
X |
|
X |
Teleconferences
with Sites |
|
X |
|
|
Questionnaire
Development |
|
X |
|
|
Questionnaire
Analysis |
|
X |
|
|
Prepare
Feasibility Report |
|
X |
|
|
Theradex
Oncology will:
A. | Obtain
Confidential Disclosure Agreements (CDAs) from potential sites – if applicable. |
Feasibility
Assumptions |
|
|
Total
number of sites to be assessed |
|
6 |
Task
List |
|
Shuttle |
|
Theradex |
Protocol
Development, Review, and Approval |
|
X |
|
|
Model
ICF Template and Amendments Development |
|
X |
|
|
Develop
and Approve Country Specific ICF Templates and Amendments |
|
X |
|
|
Resolve
Country Specific Site Informed Consent Issues |
|
X |
|
|
Prepare
Study Operations Manual |
|
|
|
X |
Prepare
Regulatory Binder |
|
|
|
X |
Copy/Distribute
Protocol and IB |
|
|
|
X |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Theradex
Oncology will:
A. |
Prepare
the Investigator Site File. The Investigator Site File describes study logistics and other issues related to the conduct of the study.
The Investigator Site File will be finalized prior to the first SIV. Theradex Oncology assumes two sponsor reviews of the Investigator
Site File. |
|
|
B. |
Prepare
the Pharmacy Binder. The Pharmacy Binder describes study logistics and other issues related to the conduct of the study. The Pharmacy
Binder will be finalized prior to the first SIV. Theradex Oncology assumes two sponsor reviews of the Pharmacy Binder. |
|
|
C. |
Distribute
protocol, investigator brochure, study manuals, and project documentation to study site. |
|
|
D. |
Prepare
and submit Annual Safety Reports/Development safety reports to regulatory authorities. |
1.3.3 | Regulatory
Documents |
Task
List |
|
Shuttle |
|
Theradex
|
Obtain
initial IRB/IEC documents |
|
|
|
X |
Collect
financial disclosure for each investigator |
|
|
|
X |
IRB
submission of documents |
|
|
|
X |
Theradex
Oncology will:
A. |
Collect
initial site IRB/IEC regulatory documents and financial disclosures. Theradex Oncology will maintain copies of this documentation
and provide full sets to Shuttle at the end of the study or at any time as requested by Shuttle. The regulatory documents will be
available for Shuttle’s review on the Theradex Oncology Client Portal. The regulatory documentation to be collected will include: |
|
○ |
IRB
approval of protocol and informed consent document |
|
○ |
Evidence
of Investigator Brochure (IB) submission to IRB |
|
○ |
IRB
membership list |
|
○ |
Financial
Disclosure (FD) form |
|
○ |
Any
other documents specified by individual national agencies/authorities |
|
○ |
Theradex
Oncology will provide Shuttle additional documentation upon request |
B. | Submit
IRB documents to study sites local/central IRB and track timelines and progress through IRB
approval. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Task
List |
|
Shuttle |
|
Theradex
|
Prepare
site contract & budget template |
|
|
|
X |
Negotiate
budget and execute CTAs |
|
|
|
X |
Administer
grant payments |
|
|
|
X |
Theradex
Oncology will:
A. |
Prepare
site contract and budget templates in collaboration with Shuttle. Finalize contract and budget upon Shuttle’s approval. |
|
|
B. |
Negotiate
study budgets and clinical study agreements with the study site(s). Theradex Oncology will include the fully executed final agreements
in the Electronic Trial Master File (eTMF) for site activation. |
|
|
C. |
Administer
payment of investigator grants. Theradex Oncology will manage and administer grant payments for all sites. |
1.3.5 | Qualification
Visits |
Task
List |
|
Shuttle |
|
Theradex
|
Prepare
agenda and presentation materials/slides |
|
X |
|
|
Prepare
visit confirmation letters |
|
X |
|
|
Conduct
site qualification visits |
|
X |
|
|
Submit
Follow up letter |
|
X |
|
|
Provide
site qualification report |
|
X |
|
|
Theradex
Oncology will:
Conduct
one pre-study (site qualification) visit to the study site(s). Theradex Oncology will determine the qualification of the sites for study
conduct and subject recruitment, as well as the experience and availability of the Investigator for the supervision and conduct of the
trial. The topics that will be evaluated during the qualification will be outlined in the Monitoring Plan.
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Qualification
Visit (QV) Assumptions |
|
|
On-Site |
|
Remote |
|
QV
Call |
Number
of Visits |
|
N/A |
|
N/A |
|
6
Visits |
Visit
Prep Time |
|
N/A |
|
N/A |
|
6.5
hours |
Visit
On-Site Time |
|
N/A |
|
N/A |
|
Visit
Report /Report review Time |
|
N/A |
|
N/A |
|
Visit
Findings Follow up Time |
|
N/A |
|
N/A |
|
Visit
Travel Time |
|
N/A |
|
N/A |
|
N/A |
Task
List |
|
Shuttle |
|
Theradex
|
Prepare
agenda and presentation materials/slides |
|
|
|
X |
Prepare
visit confirmation letters |
|
|
|
X |
Conduct
site initiation visits |
|
|
|
X |
Submit
follow-up letter |
|
|
|
X |
Provide
site initiation report |
|
|
|
X |
Theradex
Oncology will:
Conduct
one study initiation visit (SIV) to study sites. (Note: Shuttle may elect to participate in the SIV as this is an opportunity to meet
directly with the research staff. The Theradex Oncology Medical Monitor will participate to the SIV (about 1 hours is foreseen). The
topics that will be presented and reviewed during the Site Initiation Visit will be outlined in the Monitoring Plan.
Site
Initiation Visit (SIV) Assumptions |
|
|
On-Site |
|
Remote |
Number
of Visits |
|
N/A |
|
6
visits |
Visit
Prep Time |
|
N/A |
|
2
hours |
Visit
On-Site Time |
|
N/A |
|
8
hours |
Visit
Report /Report review Time |
|
N/A |
|
4.5
hours |
Visit
Findings Follow up Time |
|
N/A |
|
1.5
hours |
Visit
Travel Time |
|
N/A |
|
N/A |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Task
List |
|
Shuttle |
|
Theradex
|
Project
Management |
|
|
|
X |
Prepare
Project Management Plan |
|
|
|
X |
Approve
Project Management Plan |
|
X |
|
|
Prepare
Communication Plan |
|
|
|
X |
Approve
Communication Plan |
|
X |
|
|
Prepare
eTMF Plan |
|
|
|
X
|
Approve
eTMF Plan |
|
X |
|
|
Prepare
Monitoring Plan |
|
|
|
X |
Approve
Monitoring Plan |
|
X |
|
|
Prepare
Risk Assessment Plan |
|
|
|
X |
Approve
Risk Assessment Plan |
|
X |
|
|
Prepare
Medical Plan |
|
|
|
X |
Approve
Medical Plan |
|
X |
|
|
Prepare
Safety Plan |
|
|
|
X |
Approve
Safety Plan |
|
X |
|
|
Lab/PK
Manual |
|
|
|
X |
Set
up electronic Trial Master File (Veeva Vault), including site files |
|
|
|
X |
Maintain
electronic Trial Master File |
|
|
|
X |
Project
Kick off Meeting |
|
X |
|
X |
Project
Team Meetings (Theradex Oncology and Shuttle) |
|
X |
|
X |
Internal
Team Meetings |
|
|
|
X |
Status
Reports via CTMS |
|
|
|
X |
Investigator
Site Safety Calls |
|
X |
|
X |
Protocol
Deviation Meetings |
|
X |
|
X |
Risk
Review Meetings |
|
X |
|
X |
Quarterly
Budget Review Meetings |
|
X |
|
X |
Steering
Committee Meetings |
|
X |
|
X |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Theradex
Oncology will:
A. |
Be
responsible for the day-to-day Project Management of this study in close collaboration with the Project Management personnel at Shuttle.
Theradex Oncology will provide Shuttle a primary contact (Project Manager) to coordinate all aspects of this study. Project management
responsibilities include, but are not limited to: |
| ○ | Maintaining
regular contact with Shuttle and functioning as the primary contact between the two companies. |
| | |
| ○ | Providing
day-to-day direction to the Theradex Oncology Project Team and resolving project issues among
team members, functional line managers, and other personnel when necessary. |
| | |
| ○ | Coordinating
communications within the entire Project Team. All contact with Shuttle will be documented
and filed in the project electronic Trial Master File. |
| | |
| ○ | Updating
Shuttle on an ongoing basis and offering solutions to any project-related issues, via regular
teleconferences. |
| | |
| ○ | Report
to Shuttle immediately when delays of milestones and deliverables occur or are foreseen,
including a proposed action plan to resolve issues and to ensure compliance with milestones
and deliverables. |
B. |
Prepare
the Project Management Plan. Theradex Oncology will prepare the Project Management Plan according to Theradex Oncology SOPs. Shuttle
will review and approve the Plan. Completion of the Project Management Plan is expected prior to the first Site Initiation Visit.
Theradex Oncology assumes two reviews from Suttle of the document. |
|
|
C. |
Prepare
the study Communication Plan. Theradex Oncology will prepare the Communication Plan according to Theradex Oncology SOPs. Shuttle
will review and approve the Plan. Completion of the Communication Plan is expected during the first month of the contract. Theradex
Oncology assumes two reviews from Shuttle of the document. |
|
|
D. |
Prepare
the eTMF Plan. Theradex Oncology will prepare the eTMF Plan according to Theradex Oncology SOP. Theradex Oncology assumes two Shuttle
reviews of the document. |
|
|
E. |
Prepare
the study Monitoring Plan. Theradex Oncology will prepare the plan according to Theradex Oncology SOPs. Shuttle will review and approve
the Plan. Theradex Oncology assumes two Shuttle reviews of the document. Completion of the Monitoring Plan is expected prior to the
first routine monitoring visit. |
|
|
F. |
Prepare
the study Risk Assessment Plan. Theradex Oncology will prepare the Risk Assessment Plan according to Theradex Oncology SOPs. Shuttle
will review and approve the Plan. Completion of the Risk Assessment Plan is expected prior to the first site activated. Theradex
Oncology assumes two Shuttle reviews of the document. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
G. |
Prepare
the Medical Plan. Theradex Oncology will prepare the Medical Plan according to Theradex Oncology’s SOPs. Shuttle will review
and approve the Plan. Completion of the Medical Plan is expected to be finalized prior to the first Site Initiation Visit. Theradex
Oncology assumes two Shuttle reviews of the document. |
|
|
H. |
Prepare
the study Safety Management Plan. Theradex Oncology will prepare the Safety Management Plan according to Theradex Oncology SOPs.
Shuttle will review and approve the plan. The Safety Management Plan will be finalized prior to the first SIV. Theradex Oncology
assumes two Shuttle reviews of the document. |
|
|
I. |
Prepare
Lab/PK manual. The Lab/PK manual describes the sample collection, handling and logistics for the study. The Lab/PK manual should
be finalized prior to the first site initiation visit. Theradex Oncology assumes two reviews of the Lab/PK manual. |
|
|
J. |
Create
and maintain the eTMF in Veeva Vault for Shuttle. Veeva Vault is a tool which provides access to documents posted by Theradex Oncology
such as PDFs of the monitoring visit reports, telephone communication logs, meeting minutes, and IRB records, documents from 3rd
Party Vendors, etc. The Theradex Oncology project staff will utilize Veeva Vault to rapidly disseminate project specific information
to all study team members. Shuttle will have access to the eTMF. Theradex Oncology has assumed that a total of 3,032 final archived
documents will be uploaded to the eTMF. In case the number of documents goes beyond 3,032; Shuttle and Theradex Oncology will need
to revise the cost for the eTMF. Theradex to continually monitor document uploads, track against anticipated archive number, and
provide to Shuttle advanced projections of the anticipated number to give advanced warning of exceeding these projections. Details
will be provided in the eTMF Plan. TMF provision/archival is anticipated to occur within two months of completion of the final CSR. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
K. |
Conduct a kick-off meeting with representatives of Shuttle at the beginning of the
project. |
The
purpose of this meeting will be to discuss the following:
| ○ | Primary
points of contact within each company |
| | |
| ○ | Review
the roles and responsibilities of team members |
| | |
| ○ | Review
the study procedures, protocol, and important study endpoints |
| | |
| ○ | Reiterate
reporting requirements |
| | |
| ○ | Review
the Communication Plan |
| | |
| ○ | Review
the project timelines and scope of work |
| | |
| ○ | Review
the Risk Management Plan and escalation plans |
| | |
| ○ | Clarify
any other ad hoc issues |
The
Theradex Oncology Project Manager will lead the presentations to the group regarding Theradex Oncology’s responsibilities. The
project team members attending the meeting will be the Project Manager, Project Coordinator, CRA(s), Medical Monitor, Safety Coordinator,
Data Analyst, and Document Specialist personnel as appropriate for the project.
Kick
Off Meeting Assumptions |
Estimated
Meeting attendees |
|
9 |
Meeting
frequency |
|
Once |
Meeting
duration |
|
4
hours |
L. | Theradex
Oncology and representatives of Shuttle (including external vendors) will meet, via teleconference,
for trial logistic and operations meetings during the study. Theradex Oncology participants
will include the Project Manager for each meeting. Other study team members such as Data
Management and CRA(s) will join regularly as appropriate for the project. It is anticipated
that the Medical Monitor will join half the scheduled calls. Topics to be discussed during
the teleconferences include, but are not limited to; status of site activation, patient recruitment
and enrollment, monitoring visits and data completion status, drug distribution, and site
management problems and solutions. |
Project
Teleconference Assumptions |
Teleconference
attendees (on average) |
|
2-3 |
Teleconference
frequency |
|
Monthly |
Meeting
duration |
|
1
hour |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
M. | Theradex
Oncology will conduct regular internal project team meetings. These meetings should include
representatives from each functional group, as needed, depending on the issues and the stage
of the project. |
Internal
Meeting and Discussion Assumptions |
Team
members |
|
8 |
Meeting
communication frequency |
|
Monthly |
Time
allotted |
|
1
hour |
N. | Update
the trial status on the Theradex Oncology CTMS. Shuttle will have 24/7 access to the CTMS.
For budgeting purposes, it is assumed that Theradex Oncology’s standard information
from the CTMS will be provided. |
| |
O. | Theradex
Oncology will conduct Investigator Site Safety Call with Shuttle and the representatives
from the study sites (Principal Investigator, Sub-Investigator, etc.). Theradex Oncology
participants will include the Medical Monitor and the Clinical Operations team. Topics to
be discussed will include, but not be limited to the patient safety, patient recruitment
and potential patient(s). |
Investigator
Site Safety Calls |
Team
members |
|
2-3 |
Meeting
communication frequency |
|
Every
2 weeks |
Time
allotted |
|
0.5
hours |
P. | Theradex
Oncology will conduct Protocol Deviation Meetings with Shuttle. Theradex Oncology participants
will include the Clinical Operations team. Topics to be discussed will include, but not be
limited to the protocol deviations and their impact on the overall study conduct. |
Protocol
Deviation Meeting |
Team
members |
|
2-3 |
Meeting
communication frequency |
|
Quarterly |
Time
allotted |
|
1
hour |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Q. | Theradex
Oncology will conduct periodic Risk Review Meetings with Shuttle. Theradex Oncology participants
will include the Clinical Operations team. Topics to be discussed will include, but not be
limited to the study risks, mitigations and actions. |
Risk
Review Meeting |
Team
members |
|
3-4 |
Meeting
communication frequency |
|
Quarterly |
Time
allotted |
|
1
hour |
R. | Theradex
Oncology will conduct Quarterly Budget Review Meetings with Shuttle. Theradex Oncology participants
may/will include the Executive Management team (optional), the Project Manager, and the Business
Operations team. Topics to be discussed will include, but not be limited to: the study budget
(actuals vs contracted costs), Investigator fees and budget forecast. |
Quarterly
Budget Review Meeting |
Team
members |
|
2-3 |
Meeting
communication frequency |
|
Quarterly |
Time
allotted |
|
0.5
hours |
S. | Theradex
Oncology will conduct periodic Steering Committee meetings. Theradex Oncology participants
will include the Executive Management team, the Project Manager, and the Business Operations
team. Topics to be discussed will include, but not be limited to: study timeline, patient
accrual, site performance, patient data status, and study budget. |
Steering
Committee Meeting |
Team
members |
|
3 |
Meeting
communication frequency |
|
Yearly |
Time
allotted |
|
0.5
hours |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Internal
Steering Committee Meeting |
Team
members |
|
4 |
Meeting
communication frequency |
|
Every
6 months |
Time
allotted |
|
0.25
hours |
1.5.1 | Interim
Monitoring / Close-out Visits |
Task
List |
|
Shuttle |
|
Theradex |
On-Site
Monitoring |
Prepare
Visit Confirmation letters |
|
|
|
X |
Conduct
monitoring visits |
|
|
|
X |
Verify
100% of source documentation |
|
|
|
X |
Review
drug records/drug accountability |
|
|
|
X |
Review
site study file |
|
|
|
X |
Provide
site monitoring reports to Shuttle |
|
|
|
X |
Submit
Follow up letter to site |
|
|
|
X |
|
|
|
|
|
Interim
CRF Review |
|
|
|
X |
|
Close-Out
Visits |
Prepare
Visit Confirmation letters |
|
|
|
X |
Conduct
site close-out visits |
|
|
|
X |
Submit
Follow up letter |
|
|
|
X |
Provide
close-out trip report |
|
|
|
X |
Perform
post-study drug accountability |
|
|
|
X |
Study
drug return/destruction |
|
|
|
X |
Theradex
Oncology will:
A. | Conduct
Routine Monitoring Visits (RMVs) following enrollment of the first patient. Monitoring visits
will be conducted in compliance with the monitoring plan that is prepared prior to the first
monitoring visit. In general, monitoring visits will be conducted approximately every six
weeks depending on enrollment, with more frequent visits occurring during the initial part
of the study. The activities that Theradex Oncology will complete during the RMVs will be
outlined in the Monitoring Plan. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
B. | Assumptions
for the number of Routine Monitoring Days: it is estimated that 234 eCRFs will be monitored
per patient remaining on treatment for 2 months and long-term follow up. Some ‘ad-hoc’
monitoring visits have also been foreseen in case additional visits need to be performed
in preparation of the futility analysis or other unforeseen deadlines. On average, a CRA
is expected to monitor/source data verify 80 eCRFs per monitoring day. Therefore, on average,
it is expected that 3.2 monitoring days will be required to complete monitoring of a patient.
In total, for 40 patients remaining on treatment for 2 months and long-term follow up, it
is estimated that 127 monitoring days, divided over 1- and 2-day on-site and remote RMVs
as specified in the below table will be required. In case patients, on average, stay on study
longer than 2 months, or interim data cuts are to be performed the assumptions will need
to be revised. |
Routine
Monitoring Visit (RMV) Assumptions |
1
Day RMVs |
|
On-Site |
|
Remote |
Number
of Visits |
|
9
Visits |
|
67
Visits |
Visit
Prep Time |
|
3
hours |
|
3
hours |
Visit
On-Site Time |
|
8
hours |
|
8
hours |
Visit
Report /Report review Time |
|
4.5
hours |
|
4.5
hours |
Visit
Findings Follow up Time |
|
2
hours |
|
2
hours |
Visit
Travel Time |
|
6
hours |
|
N/A |
2
Day RMVs |
|
On-Site |
|
Remote |
Number
of Visits |
|
5
Visits |
|
48
Visits |
Visit
Prep Time |
|
3.5
hours |
|
3.5
hours |
Visit
On-Site Time |
|
16
hours |
|
16
hours |
Visit
Report /Report review Time |
|
5.5
hours |
|
5.5
hours |
Visit
Findings Follow up Time |
|
2.5
hours |
|
2.5
hours |
Visit
Travel Time |
|
6
hours |
|
N/A |
C. |
Conduct Long-term follow up remote monitoring calls. 2 calls per site have been foreseen. |
|
|
D. |
Conduct one study close out visit to each study site. Where possible, the final monitoring visit to the site will be a close out visit. The close out visit will be conducted at the site that received study medication and/or enrolled patient(s). Visits will be scheduled as soon as possible after the last patient has completed the study. The activities that Theradex Oncology will complete during the close out visits will be outlined in the Monitoring Plan. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Close
Out Visit (COV) Assumptions |
|
|
On-Site |
|
Remote |
Number
of Visits |
|
1
visit |
|
5
Visits |
Visit
Prep Time |
|
3
hours |
|
3
hours |
Visit
On-Site Time |
|
4
hours |
|
4
hours |
Visit
Report /Report review Time |
|
5
hours |
|
4
hours |
Visit
Findings Follow up Time |
|
2
hours |
|
1
hours |
Visit
Travel Time |
|
6
hours |
|
N/A |
Theradex
Oncology acknowledges that Shuttle has the right to co-monitor the investigational sites with Theradex Oncology monitoring personnel.
Theradex Oncology encourages Shuttle to take advantage of the co-monitoring right at the convenience of Shuttle.
1.5.2 | Site
Communication / Management |
Task
List |
|
Shuttle |
|
Theradex
|
Site
Questions/Management |
|
|
|
X |
Investigator
Safety and Site Teleconferences |
|
|
|
X |
Theradex
Oncology will:
Oversee
management of the study sites. Site management includes, but is not limited to: all activities associated with managing the investigational
site during study start-up, patient accrual, data cleaning and site close-out. Theradex Oncology will maintain regular contact with the
sites to provide protocol/eCRF support, to train personnel on study tools, to schedule monitoring visits, and to address study conduct
issues noted during monitoring visits. In addition, Theradex Oncology will respond to protocol and study administration queries and clinical
questions from the study site. Theradex Oncology will not grant eligibility or protocol deviation waivers without the prior approval
of Shuttle. Theradex Oncology will not permit adjustments to the study evaluation requirements or dose attenuation requirements without
the approval of Shuttle.
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
1.5.3 | Medical
Monitoring and Pharmacovigilance |
Task
List |
|
Shuttle |
|
Theradex
|
Medical
Monitor |
|
|
|
X |
Safety
Desk coverage after hours |
|
|
|
X |
Document
and manage all SAEs |
|
|
|
X |
Develop
and maintain safety database |
|
|
|
X |
Submit
SAE reports to Sponsor and affiliates |
|
|
|
X |
Submit
SAE reports to Regulatory Authorities |
|
|
|
X |
Prepare
safety updates/Investigator Letter |
|
|
|
X |
Submit
SAE to clinical sites |
|
|
|
X |
SAE
reconciliation |
|
|
|
X |
Theradex
Oncology will:
A. | Provide
global medical monitoring coverage to answer all medical questions from the investigational
centers regarding patient eligibility, patient treatment, and protocol requirements. The
Medical Monitor will also assess and provide recommendations to Shuttle regarding eligibility
or protocol deviation waiver requests. |
B. | Provide
Theradex Oncology Safety Desk coverage 24 hours a day, seven days a week to maintain safety
pharmacovigilance. Theradex Oncology Safety Desk will receive global SAE reports from the
study sites. A Theradex Oncology physician will assess every SAE report to determine whether
the SAE requires expedited reporting and then the SAE report and medical assessment will
be submitted to Shuttle. Theradex Oncology will forward SAE safety reports to the FDA and
clinical centers when criteria have been met for such action. |
C. | Safety
data, which includes SAEs and data listings from the clinical database, will be reviewed
at a minimum of six-month intervals by the Theradex Oncology Medical Monitor or as warranted
based on the safety profile of the investigational product. The conclusions resulting from
the interim medical review and any emergent signals of drug-related toxicity will be communicated
to Shuttle per the Theradex Oncology Drug Safety Plan. |
D. | Maintain
an E2B compliant SAE database and reconcile the SAE report data with the adverse event information
provided in the study database periodically during the course of the project. Defined variables
must match or have a logical correlation. Defined variables will be agreed upon prior to
the start of the study. Reconciliation of the SAE data with the adverse event data reported
in the study database will occur approximately every quarter following initiation of patient
enrollment. The last SAE reconciliation effort will occur just prior to database lock. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
SAE
and SUSAR Assumptions |
Total
SAEs |
|
27
SAEs (50%) |
Total
SUSARs |
|
3
(10% of SAEs) |
1.6 | Statistical
Analysis and Medical Writing Services |
Task
List |
|
Shuttle |
|
Theradex |
Prepare
Randomization Plan |
|
|
|
X |
Approve
Randomization Plan |
|
X |
|
|
Prepare
Statistical Analysis Plan |
|
|
|
X |
Approve
Statistical Analysis Plan |
|
X |
|
|
Prepare
TLF Plan |
|
|
|
X |
Approve
TLF Plan |
|
X |
|
|
Sample
Size Calculations |
|
|
|
X |
Final
Data Analysis |
|
|
|
X |
Prepare
Clinical Study Report (CSR) template |
|
X |
|
|
Prepare
CSR |
|
X |
|
|
CSR
subsequent drafts – up to 2 drafts |
|
X |
|
|
Patient
Narratives |
|
X |
|
|
Final
CSR |
|
X |
|
|
Theradex
Oncology will:
A. | Prepare
a statistical analysis plan (SAP) that is in accordance with the objectives of the final
study protocol. The SAP is typically comprised of a protocol summary including study endpoint
definitions, mock-up templates for the analysis tables, listings and figures to be included
in the clinical study report, and a description of technical programming and/or analysis
instructions. Shuttle will review and approve the SAP. Theradex Oncology assumes two reviews
of the document. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
B. | Generate
tables and data listings and figures for data analysis using SAS® software. Descriptive
statistics will be provided for demographic, adverse event, laboratory, and response data.
Patient narratives, if required, will be provided. Theradex Oncology will create a draft
package of mock-up templates for the analysis tables and listings to be included in the final
clinical study report, as part of the SAP. The mock-up templates will contain the information
collected on the CRF in the form of summary tables and patient listings. |
TLFs
Programming |
|
|
#
of Tables – Unique |
|
37 |
#
of Tables – repeat |
|
21 |
#
of Listings – Unique |
|
31 |
#
of Listings – Repeat |
|
4 |
#
of Figures – Unique |
|
3 |
#
of Figures - Repeat |
|
2 |
C. | Prepare
analysis-datasets and execute the programs to generate the final tables and listings after
completion of the database lock. SDTM programming is not foreseen as part of the scope of
this project. |
D. | Perform
a Quality Control (QC) check of tables and listings and figures in accordance with Theradex
Oncology’s SOP. |
1.7 | Data
Management Services |
1.7.1 | Patient
Registration System, Monitor Express and Client Portal |
Task
List |
|
Shuttle |
|
Theradex
|
Design
Registration Script |
|
|
|
X |
Configure
Registration System |
|
|
|
X |
Manage
Registration System |
|
|
|
X |
Configure
and Manage Monitor Express |
|
|
|
X |
Train
Users |
|
|
|
X |
Theradex
Oncology will:
A. | Set
up and maintain Theradex Oncology’s proprietary automated interactive web registration
system (IWRS) for patient enrollment. |
B. | Test,
validate, and QC the system prior to implementation. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
C. | Provide
user training and user name and password information for each user for the IWRS. Access to
the IWRS will be through a secure https connection. Access to the IWRS at the site level
will be determined at the start of the study. All IWRS screens will be displayed in English. |
D. | Provide
a user manual for the IWRS with step-by-step instructions for enrolling a patient as well
as user management. The IWRS will collect the site ID and username. Actual enrollment will
proceed by collecting a local patient ID (for audit tracking), the patient’s gender
and any other necessary information that may be required for either registration or randomization.
When appropriate, Shuttle and Theradex Oncology will agree upon the stratification factors
in the protocol. Following each entry into the IWRS a fax and/or email confirmation will
be sent to the user, the site, Shuttle and Theradex Oncology clinical staff. |
E. | Provide
support and technical assistance 8:00 am to 8:00 pm U.S. Eastern Time to answer routine questions.
Theradex Oncology will provide a caller ID to the central site, which will allow enrollment
at any sub-site. |
F. | Configure,
prepare, and manage Monitor Express for CRA centralized access to all study related databases
and as a tool for Shuttle to have real time access to monitor findings. |
Task
List |
|
Shuttle |
|
Theradex |
Data
Management Plan |
|
|
|
X |
Approve
Data Management Plan |
|
X |
|
|
Design
and draft eCRFs |
|
|
|
X |
Approve
eCRFs |
|
X |
|
|
EDC
Event Set-Up |
|
|
|
X |
Write
EDC User Manual |
|
|
|
X |
EDC
Training |
|
|
|
X |
Database
development |
|
|
|
X |
Reconciliation
of Safety and Clinical databases |
|
|
|
X |
Edit
Check |
|
|
|
X |
Adverse
Event and Medication coding |
|
|
|
X |
Database
QC and database lock |
|
|
|
X |
SAS
dataset |
|
|
|
X |
Prepare
Data Transfer Plan |
|
|
|
X |
Transfer
Data |
|
|
|
X |
Theradex
Oncology will:
A. | Design
and program the electronic case report forms (eCRFs) based upon the protocol provided by
Shuttle. Theradex Oncology assumes this study will require no more than 55 unique forms,
of which 80% are from the Theradex Oncology global library, requiring minimal customization.
Shuttle will review and approve the eCRFs prior to implementation. Only one round of changes
is assumed. Customization of forms and/or changes that exceed these limits can result in
additional costs. |
B. | Use
Electronic Data Capture (EDC) for this project. The sites will enter the data directly into
the EDC system. The EDC data is maintained in an Zelta Clinical Development database. Data
entry instructions for the sites will be incorporated within the EDC system, in order to
provide guidance on entry procedures specific to the study. |
C. | Provide
an Initial EDC training session for the clinical centers. |
D. | Prepare
a Data Management Plan outlining data collection and flow processes ongoing throughout the
study. Theradex Oncology’s standard format will be used, provided that Shuttle will
review and approve the Data Management Plan prior to finalization. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
E. | Set
up a study database. Theradex Oncology’s standard study database format will be utilized.
Included in the database are data entry/data posting programs, audit listing programs, CRF
tracking and delinquency programs. Each program is validated and 21 CFR Part 11 compliant. |
F. | Design
and program global electronic case report forms (eCRFs) based upon the protocol provided
by Shuttle. Shuttle will approve the eCRFs prior to implementation. Theradex Oncology assumes
two sponsor reviews of each eCRF. |
G. | Utilize
generic edit checks which are programmed into the database. Protocol-specific parameters
may be supplied at study start-up and additional checks may be programmed as needed. Data
exceptions identified by the edit checks may be reviewed and queried as deemed appropriate
by clinical staff. Theradex Oncology assumes no more than 150-200 custom edit checks will
be programmed. If more custom Edit Checks are necessary, additional costs may apply. |
H. | Review
all data for completeness and clarity, ensuring that there are no inconsistent or unexpected
data. Theradex Oncology will evaluate all data for both safety and efficacy and will resolve
any data conflicts or internal inconsistencies. EDC data will be reviewed prior to each monitoring
visit. |
I. | Process
data utilizing Theradex Oncology’s standard study database format where possible. The
Theradex Oncology team will work with Shuttle to reduce the total number of data tables and
data points captured to reduce the overall cost of data management services to Shuttle and
to increase the likelihood of compliance with timeliness of data reporting. |
J. | Prepare
data entry instructions in order to provide guidance on entry procedures specific to the
study. |
K. | Prepare,
issue and resolve (e.g., issue data queries for) missing and/or incomplete data. Theradex
Oncology will prepare and track each data query and follow-up with the study sites to ensure
that all data queries are resolved in a timely manner. |
L. | Code
adverse events, concomitant medications and site of disease/histology using the MedDRA, WHO-DD
and ICD-O dictionaries. |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
M. | Perform
a final database audit after the data have been entered, cleaned and coded, and queries resolved
(details to be provided in the data management plan). Theradex Oncology will supply a record
of the audit to Shuttle within ten days of completion. Once the final database is locked,
Theradex Oncology will transmit the final datasets to Shuttle. |
N. | Perform
a Final Database Lock and Data Transfer. |
O. | Prepare
Data Transfer Plans according to Theradex Oncology SOPs and manage data transfers. Theradex
Oncology will reconcile all external data with the clinical database. |
P. | Perform
SAS® data transfer to Shuttle 5 times throughout the duration of the study. This includes
one test transfer and the associated validation. |
Q. | Transfer
all data to Shuttle. |
The
deadlines for sponsor approval of IWRS and EDC specifications are critical to keeping the project on schedule. Delays in approval can
result in significant launch delays.
1.9 | Investigational
Drug Management |
Task
List |
|
Shuttle |
|
Theradex |
|
Theradex
separate work order |
Sponsor
Coordination |
|
|
|
|
|
X |
Investigational
Product Receipt |
|
|
|
|
|
X |
Investigational
Product Shipments |
|
|
|
|
|
X |
Investigational
Product Labeling |
|
|
|
|
|
X |
Investigational
Product Storage Maintenance |
|
|
|
|
|
X |
Inventory
Reporting/tracking |
|
|
|
|
|
X |
Investigational
Product Destruction |
|
|
|
|
|
X |
Theradex
Oncology will:
A. | Not
applicable for this work order. IMP services are conducted by Theradex Oncology under a separate
work order (WO#2). |
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Appendix
2: Theradex Oncology Project Budget
Theradex
Oncology Project Budget Summary
[***]
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Milestone
Payment Schedule
[***]
Shuttle Pharmaceuticals, Inc. | |
Work Order #3: Phase 2 IPdR Glioblastoma study | 30 July 2024 |
Pass
Through Cost Summary
[***]
License
Fee Summary
[***]
Exhibit 10.2
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_001.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_002.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_003.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_004.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_005.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_006.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_007.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_008.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_009.jpg)
![](https://www.sec.gov/Archives/edgar/data/1757499/000149315224032218/ex10-2_010.jpg)
Exhibit 99.1
Shuttle
Pharma Ready to Enroll patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
GAITHERSBURG,
Md., August 14, 2024 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development
stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced
today it has entered into agreements with two of the six site locations to administer the Phase 2 clinical trial of Ropidoxuridine for
the treatment of patients with glioblastoma. Site initiation visits have been completed for two sites. The trial is now open to enroll
patients in the clinical trial.
Ropidoxuridine
(IPdR) is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma),
a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing
exclusivity upon first FDA approval for the disease.
The
Phase 2 clinical trial will be conducted on patients with the most aggressive brain tumors out there – IDH wild-type, methylation
negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients , with more than
half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially
of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company
determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical
significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed
over a period of 18 to 24 months.
“We
are pleased to be working with highly talented teams at academic medical centers on our Phase 2 trial of Ropidoxuridine for the treatment
of patients with glioblastoma,” commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “The results
of this trial will be important to the cancer community as we look for ways to leverage radiation sensitizers to increase cancer cure
rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
Shuttle
Pharma expects the Phase 2 clinical trial will be carried out at six site locations, with all sites anticipated to be treating patients
in the coming months.
“We
have carefully selected six universities and hospitals that are most likely to treat IDH wild-type, methylation negative glioblastoma
patients which should allow for more rapid enrollment of the Phase 2 trial,” added Dr. Tyvin Rich, Chief Medical Officer of Shuttle
Pharma and Professor Emeritus of Radiation Oncology, University of Virginia School of Medicine.
An
estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society
and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care.
The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected
to grow by more than 22% over the next five years.
More
information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
About
Shuttle Pharmaceuticals
Founded
in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty
pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve
the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects
of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim
to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination
with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.
Safe
Harbor Statement
Statements
in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements
concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar expressions are
intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including
factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December
31, 2023, filed with the SEC on March 20, 2024, as well other SEC filings. Any forward-looking statements contained in this press release
speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any
obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle
Pharmaceuticals
Anatoly
Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor
Contacts
Lytham
Partners, LLC
Robert
Blum
602-889-9700
shph@lythampartners.com
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Shuttle Pharmaceuticals (NASDAQ:SHPH)
過去 株価チャート
から 7 2024 まで 8 2024
Shuttle Pharmaceuticals (NASDAQ:SHPH)
過去 株価チャート
から 8 2023 まで 8 2024