MoA sounds very similar to the vascular targeting
agents in the clinic right now in that it targets the
core areas of solid tumors and leaves a viable tumor
rim supported by normal blood vasculature.

As this is preclin, I would from an investment pov.
rather go for e.g. OXGN that are already in phase
II/III clinical trials with combretastatin exploiting
exactly the same combination therapy tactic.

JMHO.

--- waveresearchlab <waveresearchlab@...> skrev:

> you have to check out the abstracts that are listed.
> go to pubmed and
> read them, let us know what you think.
>
> --- In
> experimentalandunconventional@yahoogroups.com, Lars
> Tong
> Stromberg <kokostrollet@...> wrote:
> >
> > sounds promising in what way. Doesn´t say nada
> about
> > any results..
> >
> > --- waveresearchlab <waveresearchlab@...> skrev:
> >
> > > Study of Clostridium Novyi-NT Spores in Solid
> Tumors
> > > Malignancies
> > >
> >
>
http://www.clinicaltrials.gov/ct/show/NCT00358397?order=3
> > >
> > > This study is currently recruiting patients.
> > > Verified by Sidney Kimmel Comprehensive Cancer
> > > Center July 2006
> > > Sponsored by: Sidney Kimmel Comprehensive
> Cancer
> > > Center
> > > Information provided by: Sidney Kimmel
> > > Comprehensive Cancer Center
> > > ClinicalTrials.gov Identifier: NCT00358397
> > >
> > > Purpose
> > > One time IV infusion of Clostridium novyi-NT
> spores
> > > to treat solid
> > > tumors which have not responded to standard
> therapy.
> > > Condition Intervention Phase
> > > Solid Tumors
> > > Drug: Costridium novyi-NT spores
> > > Phase I
> > >
> > > MedlinePlus consumer health information
> > >
> > > Study Type: Interventional
> > > Study Design: Treatment, Non-Randomized, Open
> Label,
> > > Uncontrolled,
> > > Single Group Assignment, Safety/Efficacy Study
> > >
> > > Official Title: Phase I Safety Study of
> Clostridium
> > > Novyi-NT Spores in
> > > Patients With Treatment-Refractory Solid Tumor
> > > Malignancies
> > > Further study details as provided by Sidney
> Kimmel
> > > Comprehensive
> > > Cancer Center:
> > > Primary Outcomes: To determine the safety
> profile,
> > > dose limiting
> > > toxicities (DLT), and maximum tolerated dose
> (MTD)
> > > of C. novyi–NT in
> > > humans with treatment-refractory solid tumor
> > > malignancies when given
> > > as a single intravenous injection.
> > > Secondary Outcomes: To document preliminary
> evidence
> > > of anti-tumor
> > > activity of C. novyi-NT in humans with
> > > treatment-refractory solid
> > > tumor malignancies when given as a single
> > > intravenous injection.; To
> > > analyze the pharmacokinetics of C. novyi-NT
> after
> > > administration to
> > > humans with treatment-refractory solid tumor
> > > malignancies when given
> > > as a single intravenous injection.; To measure
> the
> > > host immune and
> > > inflammatory response to C. novyi-NT in humans
> with
> > > treatment-refractory solid tumor malignancies
> when
> > > given as a single
> > > intravenous injection.
> > > Expected Total Enrollment: 20
> > >
> > > Study start: July 2006; Expected completion:
> July
> > > 2008
> > > Last follow-up: July 2006; Data entry closure:
> July
> > > 2006
> > > This is a phase I dose escalation study using a
> > > single dose of
> > > Clostridium novyi-NT spores in patients with
> > > treatment-refractory
> > > solid tumor malignancies. The overall objective
> of
> > > this study is to
> > > determine the safety and document any
> preliminary
> > > evidence of
> > > anti-tumor activity in this patient population.
> > >
> > > Eligibility
> > > Ages Eligible for Study: 18 Years and above,
> > > Genders Eligible for
> > > Study: Both
> > > Criteria
> > >
> > > Inclusion Criteria:
> > >
> > > 1. Documented solid tumor malignancy as
> proven by
> > > referral CT scan
> > > of the chest, abdomen and pelvis.
> > > 2. Referral CT scan that demonstrates a
> necrotic
> > > core in primary
> > > target measuring at least 1 cm in diameter.
> > > 3. Patients must be refractory to standard
> > > chemotherapy or for whom
> > > no standard treatment exists. At least four
> weeks
> > > must have elapsed
> > > since completion of any prior chemotherapy.
> > > 4. Patients must have measurable disease;
> defined
> > > as at least one
> > > lesion whose longest diameter can be accurately
> > > measured as >2 cm.
> > > 5. ECOG performance status of 0 or 1.
> > > 6. Prior locoregional therapy, including
> > > cryotherapy,
> > > radiofrequency ablation, or regional
> chemotherapy is
> > > allowed if at
> > > least 6 weeks have elapsed.
> > > 7. Prior radiation therapy is allowed. At
> least 6
> > > weeks must have
> > > elapsed since the completion of radiation
> therapy
> > > and the patient must
> > > have recovered from side effects.
> > > 8. Prior systemic radionuclide therapy is
> > > allowed. At least 4 weeks
> > > must have elapsed since completion of the
> therapy.
> > > 9. Prior surgery is allowed. At least 6 weeks
> > > must have elapsed
> > > since the completion of major surgery and the
> > > patient must be fully
> > > recovered from this surgery and any attendant
> > > post-surgical complications.
> > > 10. Patients must be 18 years of age or older
> > > 11. Patients of childbearing potential must
> use
> > > adequate birth
> > > control measures
> > > 12. Negative serum pregnancy test for females
> of
> > > childbearing potential.
> > >
> > > Exclusion Criteria:
> > >
> > > 1. Weight < 135 kg
> > > 2. Chronic renal failure requiring
> hemodialysis
> > > or peritoneal dialysis
> > > 3. Tumor lesion that is not accessible to
> > > percutaneous drainage.
> > > 4. Any single contiguous lesion greater than
> >
> > > 12.5 cm.
> > > 5. The sum of the largest cross-sectional
> > > diameters from any number
> > > of non-contiguous lesions > 2 cm cannot be > 25
> cm.
> > > 6. Use of any investigational drug within 30
> days
> > > prior to
> > > screening or within 5 half-lives of the agent,
> > > whichever is longer.
> > > 7. Any documented evidence of primary brain
> > > malignancy or brain
> > > metastases
> > > 8. Patients with any clinically significant
> > > ascites or
> > > portosystemic hypertension, chronic jaundice or
> > > cirrhosis.
> > > 9. Patients with indwelling intrahepatic
> arterial
> > > pumps
> > > 10. Patients with prosthetic joints,
> prosthetic
> > > valves, pacemakers
> > > or any other implanted foreign materials.
> > > 11. Patients with any clinically significant
> > > pleural effusions
> > > 12. Patients with any evidence of hemodynamic
> > > compromise from a
> > > pericardial effusion.
> > > 13. Documented cirrhosis of the liver by
> clinical
> > > scenarios
> > > encompassing radiographic, clinical and
> laboratory
> > > results
> > > 14. Ongoing treatment with any
> immunosuppressive
> > > agent(s)
> > > 15. Any evidence of serious infections or
> history
> > > of chronic or
> > > recurrent infectious disease in the previous 3
> > > months.
> > > 16. Patients with opportunistic infections
> > > 17. Documented HIV infection.
> > > 18. Active or chronic Hepatitis B or Hepatitis
> C.
> > > 19. Presence of a transplanted solid organ.
> > > 20. History of an autoimmune disorder
> > > 21. History of Diabetes Mellitus (type I or
> II)
> > > 22. History of rheumatic fever, endocarditis,
> or
> > > greater than mild
> > > valvular disease.
> > > 23. Patients who depend upon COX II inhibitors
> or
> > > NSAIDS
> > > 24. History of ongoing and active arterial
> > > vasculopathy or evidence
> > > of end organ damage.
> > > 25. History of an ischemic insult in the
> previous
> > > 12 months
> > > 26. History of venous or lymphatic stasis
> > > resulting in venous stasis
> > > ulcers or greater than 2+ edema or lymphedema.
> > > 27. History of a splenectomy
> > > 28. Patients with a documented Penicillin or
> > > Metronidazole allergy
> > > 29. Patients with a documented allergy to
> > > radiology contrast dye.
> > > 30. Patient with active diverticulitis
> > > 31. Patient with active dental abscesses
> > > 32. Patients with inflammatory bowel disease
> > > 33. Patients with angiosarcoma
> > > 34. Patients with history of a positive PPD,
> past
> > > TB infection or
> > > past atypical mycobacterium infection.
> > >
> > > Location and Contact Information
> > > Please refer to this study by ClinicalTrials.gov
> > > identifier NCT00358397
> > >
> > > Luis A Diaz, MD 443-287-6539 ldiaz1@...
> > >
> > > Maryland
> > > Johns Hopkins Medical Institutes,
> Baltimore,
> > > Maryland, 21231,
> > > United States; Recruiting
> > > Luis A Diaz, MD, Principal Investigator
> > > Katherine Thornton, MD, Sub-Investigator
> > > Bert Vogelstein, M.D., Sub-Investigator
> > > Ross Donehower, M.D., Sub-Investigator
> > > Michael Choti, M.D., Sub-Investigator
> > > Kenneth Kinzler, Ph.D., Sub-Investigator
> > >
> > > Study chairs or principal investigators
> > >
> > > Luis A Diaz, MD, Principal Investigator, Johns
> > > Hopkins Medicine
> > >
> > > More Information
> > >
> > > Publications
> > >
> > > Diaz LA Jr, Cheong I, Foss CA, Zhang X, Peters
> BA,
> > > Agrawal N,
> > > Bettegowda C, Karim B, Liu G, Khan K, Huang X,
> Kohli
> > > M, Dang LH, Hwang
> > > P, Vogelstein A, Garrett-Mayer E, Kobrin B,
> Pomper
> > > M, Zhou S, Kinzler
> > > KW, Vogelstein B, Huso DL. Pharmacologic and
> > > toxicologic evaluation of
> > > C. novyi-NT spores. Toxicol Sci. 2005
> > > Dec;88(2):562-75. Epub 2005 Sep 14.
> > >
> > > Folkman J. A novel anti-vascular therapy for
> cancer.
> > > Cancer Biol Ther.
> > > 2004 Mar;3(3):338-9. Epub 2004 Mar 29. No
> abstract
> > > available.
> > >
> > > Dang LH, Bettegowda C, Agrawal N, Cheong I, Huso
> D,
> > > Frost P, Loganzo
> > > F, Greenberger L, Barkoczy J, Pettit GR, Smith
> AB
> > > 3rd, Gurulingappa H,
> > > Khan S, Parmigiani G, Kinzler KW, Zhou S,
> Vogelstein
> > > B. Targeting
> > > vascular and avascular compartments of tumors
> with
> > > C. novyi-NT and
> > > anti-microtubule agents. Cancer Biol Ther. 2004
> > > Mar;3(3):326-37. Epub
> > > 2004 Mar 12.
> > >
> >
>
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed
> > >
> > > Bettegowda C, Dang LH, Abrams R, Huso DL,
> Dillehay
> > > L, Cheong I,
> > > Agrawal N, Borzillary S, McCaffery JM, Watson
> EL,
> > > Lin KS, Bunz F,
> > > Baidoo K, Pomper MG, Kinzler KW, Vogelstein B,
> Zhou
> > > S. Overcoming the
> > > hypoxic barrier to radiation therapy with
> anaerobic
> > > bacteria. Proc
> > > Natl Acad Sci U S A. 2003 Dec 9;100(25):15083-8.
> > > Epub 2003 Dec 1.
> > >
> > > Dang LH, Bettegowda C, Huso DL, Kinzler KW,
> > > Vogelstein B. Combination
> > > bacteriolytic therapy for the treatment of
> > > experimental tumors. Proc
> > > Natl Acad Sci U S A. 2001 Dec
> 18;98(26):15155-60.
> > > Epub 2001 Nov 27.
> > >
> > > Agrawal N, Bettegowda C, Cheong I, Geschwind JF,
> > > Drake CG, Hipkiss EL,
> > > Tatsumi M, Dang LH, Diaz LA Jr, Pomper M,
> Abusedera
> > > M, Wahl RL,
> > > Kinzler KW, Zhou S, Huso DL, Vogelstein B.
> > > Bacteriolytic therapy can
> > > generate a potent immune response against
> > > experimental tumors. Proc
> > > Natl Acad Sci U S A. 2004 Oct
> 19;101(42):15172-7.
> > > Epub 2004 Oct 7.
> > >
> > > Jain RK, Forbes NS. Can engineered bacteria help
> > > control cancer? Proc
> > > Natl Acad Sci U S A. 2001 Dec
> 18;98(26):14748-50. No
> > > abstract available.
> > >
> > >
> > >
> > >
> > >
> > >
> > > Yahoo! Groups Links
> > >
> > >
> >
>
http://groups.yahoo.com/group/experimentalandunconventional/
> > >
> > >
> > >
> >
>
experimentalandunconventional-unsubscribe@yahoogroups.com
> > >
> > >
> > >
> > >
> > >
> >
>
>
>
>
>
>
>
> Yahoo! Groups Links
>
>
http://groups.yahoo.com/group/experimentalandunconventional/
>
>
>
experimentalandunconventional-unsubscribe@yahoogroups.com
>
>
>
>
>