THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net
S U M M A R Y
DIARY: February 18, 2009 08:28 AM Wednesday;
Rod Welch
Millie notice of Thermodox treatment with hyperthermia clincial study.
1...Summary/Objective
2...Thermodox with Hyperthermia for IBC Clinical Trial Announced Celsion
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CONTACTS
SUBJECTS
Thermodox IBC Treatment with Hyperthermia Pase I/II Study Clinical
2303 -
2303 - ..
2304 - Summary/Objective
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230501 - Follow up ref SDS 6 0000. ref SDS 5 0000.
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230506 - ..
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2308 - Progress
2309 -
230901 - Millie received ref DRT 1 0001 from Gwen transmitting notice of
230902 - complementary treatment for hyperthermia, and announcing a new trial.
230903 - This follows up Gwen's letter on 090204 submitting a list of
230904 - propspective treatments for managing Millie's cancer as a chronic
230905 - disease. ref SDS 3 7P9O
230907 - ..
230908 - Background working with Gwen through her practice of "Beyond the 2nd
230909 - Opinion," is listed on 090205. ref SDS 5 KI5I
230910 -
230911 - 1. Subject: Thermodox IBC Treatment with Hyperthermia
230912 - Date: Tue, 17 Feb 2009 19:38:22 -0800
230919 - ..
230920 - 2. I ran into this article (appended below) and thought you might
230921 - be interested...
230923 - ..
230924 - 3. Also, I will be sending out statements in the first week of
230925 - March. I would like to send yours (to show your zero balance).
230926 - Could you send me an address to mail it to? Thanks!
230928 - ..
230929 - 4. I hope you current regimen is working well!
230930 -
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230936 -
230938 - ..
230939 - Thermodox with Hyperthermia for IBC Clinical Trial Announced Celsion
230940 -
230941 -
230942 - 1. Medical News Today
230943 -
230944 - Celsion Commences Pivotal Phase I/II Study Of ThermoDox(R) In
230945 - The Treatment Of Recurrent Chest Wall Breast Cancer
230947 - ..
230948 - http://www.medicalnewstoday.com/articles/138775.php
230950 - ..
230951 - 2. Date: 12 Feb 2009
230953 - ..
230954 - 3. Chest Wall Breast Cancer
230956 - ..
230957 - 4. Celsion Corporation (NASDAQ: CLSN), an oncology company
230958 - dedicated to the development and commercialization of therapies
230959 - for difficult-to-treat cancers, announced today that it has
230960 - initiated a pivotal Phase I/II study of ThermoDox in
230961 - combination with hyperthermia, or heat, to treat recurrent
230962 - chest wall breast cancer, a disease with a very poor patient
230963 - prognosis and limited treatment options.
230964 -
230965 - [On 090310 0351 Millie's letter submits agenda to medical
230966 - team for meeting UCSF to evaluate response to treatment
230967 - with radiation and hyperthermia, and cites evident
230968 - worsening IBC conditions; issue of discussion for meeting
230969 - on 090312 is requirements for adjusting treatment plan.
230970 - ref SDS 7 TH5I
230972 - ..
230973 - [On 090312 0800 UCSF reports examination after 3 weeks of
230974 - treatment with radiation and hyperthermia shows strong
230975 - response to treatment, and says no adjustments to treatment
230976 - are required, and so proposes ending treatment on schedule
230977 - originally set for 090317. ref SDS 8 8P7G
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230980 - 5. The open-label, dose-escalating pivotal trial has been designed
230981 - to measure durable local complete response at the tumor site.
230982 - Celsion expects to enroll approximately 100 patients across the
230983 - United States and to complete the study by the first half of
230984 - 2010. Study locations include the Florida Cancer Institute in
230985 - Hudson, FL led by Principal Investigator Arthur Maztkowitz, MD,
230986 - New York University Hospital in New York, NY led by Silvia
230987 - Formenti, MD, and the Cancer Treatment Center of America in
230988 - Tulsa, OK led by Petra Ketterl, MD. Additional information on
230989 - the study may be found at http://www.clinicaltrials.gov.
230991 - ..
230992 - 6. Michael H. Tardugno, Celsion's President and Chief Executive
230993 - Officer, commented "We are pleased to update our partners,
230994 - particularly our shareholders, on the significant progress that
230995 - has been made on our recurrent chest wall cancer program just
230996 - three months after submitting our final protocol to the FDA.
230997 - The clinical staff has brought us one step closer to delivering
230998 - on the potential of ThermoDox to a cancer population that is
230999 - truly in need of effective treatment options, given the
231000 - debilitating nature of this disease, and we are extremely proud
231001 - of their hard work and commitment to this initiative."
231003 - ..
231004 - 7. "Recurrent cancer at the chest wall can affect a significant
231005 - number of breast cancer patients who have had a mastectomy",
231006 - noted Dr. Nicholas Borys, Celsion's VP and Chief Medical
231007 - Officer. "With no current standard of care, women with this
231008 - type of recurrence often cannot be adequately treated with
231009 - surgery, radiation, or existing chemotherapy. We believe that
231010 - the DIGNITY study will demonstrate that ThermoDox in
231011 - combination with hyperthermia will provide local tumor control
231012 - and improve quality of life."
231014 - ..
231015 - 8. About Recurrent Chest Wall Cancer
231017 - ..
231018 - Depending on risk factors, up to 40% of women with mastectomies
231019 - may experience recurrent chest wall cancer (RCW). The disease
231020 - is generally defined as the recurrence of tumor to the area of
231021 - the initial definitive treatment such as mastectomy. There are
231022 - a significant number of women diagnosed with RCW who frequently
231023 - cannot be treated with further surgical resection, radiation or
231024 - existing chemotherapy because they have exhausted available
231025 - treatment options.
231027 - ..
231028 - 9. About ThermoDox®
231029 -
231030 - ThermoDox® is Celsion's proprietary heat-sensitive liposomal
231031 - encapsulation of doxorubicin, an approved and frequently used
231032 - anti-cancer drug used in the treatment of various cancers.
231033 - Localized heat (at 40-42 degrees Celsius and above) releases
231034 - the entrapped doxorubicin from the liposome. This delivery
231035 - technology enables high concentrations of doxorubicin to be
231036 - deposited preferentially in a targeted tumor.
231038 - ..
231039 - 10. About Celsion
231040 -
231041 - Celsion is dedicated to the development and commercialization
231042 - of oncology drugs including tumor-targeting treatments using
231043 - focused heat energy in combination with heat-activated drug
231044 - delivery systems. Celsion has research, license or
231045 - commercialization agreements with leading institutions such as
231046 - the National Institutes of Health, Duke University Medical
231047 - Center, University of Hong Kong, Cleveland Clinic, North Shore
231048 - Long Island Jewish Health System.
231050 - ..
231051 - 11. For more information on Celsion, visit our website:
231052 -
231053 - http://www.celsion.com.
231055 - ..
231056 - 12. Celsion wishes to inform readers that forward-looking
231057 - statements in this release are made pursuant to the "safe
231058 - harbor" provisions of the Private Securities Litigation Reform
231059 - Act of 1995. Readers are cautioned that such forward-looking
231060 - statements involve risks and uncertainties including, without
231061 - limitation, unforeseen changes in the course of research and
231062 - development activities and in clinical trials by others;
231063 - possible acquisitions of other technologies, assets or
231064 - businesses; possible actions by customers, suppliers,
231065 - competitors, regulatory authorities; and other risks detailed
231066 - from time to time in the Company's periodic reports filed with
231067 - the Securities and Exchange Commission.
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