Hi Supertramp
you are correct, the first Her-Vaxx update which we received on the 17th December, which at that time reported that out of the ten patents we had
5 partial responses
4 with stable disease
1 that did was appear to be reported on
.
now in the latest release (Feb March investor presentation ) we have
1 complete response
5 with partial responses
4 with stable disease.
In addition to the above we have a full report on the the B Vaxx trial which we got from the Ohio state University .
which I have read, and from within that document I would like to highlight the following which details some background and discussion around " "Patient 2C" in that trial whom had the best response and highlights what many have been saying about the negative impact of the Chemo upon the immune response.
Taken from the clinical trial document:
Phase 1 Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines emulsified in Montanide ISA 720VG and nor-MDP Adjuvant in Patients with Advanced Solid Tumors
Prior to enrollment in our study, this patient was diagnosed with T2N2bM0 poorly differentiated carcinoma of the right parotid gland and underwent radical parotidectomy and selective right neck dissection. The surgical pathology revealed 25 lymph nodes positive for metastatic disease. Interestingly, the tumor also had "patchy foci" of 3+ Her2/neu staining based on immunohistochemistry on a background of equivocal 2+ positivity. Recurrence was discovered in the right axillary lymph nodes about 2 years later and the patient underwent right axillary lymph node dissection which revealed that four of 46 lymph nodes were positive. He was subsequently enrolled in our study.
Patient 2C received seven 6 months booster vaccinations. Patient 2C travelled to Columbus, Ohio from Seattle, Washington to receive his first vaccine on 05/30/2012 and two boosters at 3 weeks apart. The patient returned every 6 months through 12/10/2015 to receive the 7 booster vaccinations, spanning 3.5 years.
The exceptional response in this patient may also be due to the fact that this patient did not receive any chemotherapy prior to enrollment. Thus, his immune system was very much intact and likely more responsive to vaccine treatment. This is an important fact as the vaccine therapy should be more effective in such patients .
Considering the likely effects on the immune system from Chemo on the effectiveness of these new B cell vaccines and adverse patient outcomes to the Chemo, I think we will see steps taken by IMU management (with the FDA) to ensure that more patients will enter our B cell trials while cancer is at an earlier stage and where chemo has not been used, thus giving the patients the best fighting chance with the combination of their immune system and one of Imugenes peptide B cell vaccines.
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