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Thxs Waitforit53! Great post
$VCEL Institutional + Mutual Fds = +55%
https://www.cnbc.com/quotes/?symbol=VCEL&tab=ownership
KEYTRUDA, improved overall survival by more than 30 percent compared to ipilimumab, an anti-CTLA-4 antibody, in the treatment of advanced melanoma
http://www.businesswire.com/news/home/20150419005027/en/KEYTRUDA%C2%AE-pembrolizumab-Merck%E2%80%99s-Anti-PD-1-Therapy-Demonstrates-Superior
The ones that have failed Opdivo or Keytruda monotherapies are essentially terminal. Only 25% respond to either monotherapy. Their only hope for life are a Combo therapy such as PISCES and hopefully they qualify.
$ONCS/Keytrudas Combo has moved on to a new trial following the UCSF trial
pIL-12 and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment (PISCES)
https://clinicaltrials.gov/ct2/show/NCT03132675?term=Oncosec&recrs=ab&cond=Cancer&rank=2
For those that need treatment these are the Inclusion/Exclusion trial that must be met to be eligible:
Inclusion Criteria:
• In order to be eligible for participation in this trial, the patient must meet all the following:
1. Pathologically documented unresectable melanoma, AJCC Stage III or IV. Patients must have histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease.
2. Patients must be refractory to anti-PD-1 monoclonal antibodies (mAb) defined as pembrolizumab or nivolumab as either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label, defined as (patients must meet all of the following criteria):
2.1. Received at least 4 doses of anti-PD1 mAb for pembrolizumab; minimum dose of 240 mg given every two weeks for nivolumab in monotherapy; minimum dose of 1 mg/kg given Q3W for nivolumab in combination with ipilimumab
2.2. Progressive disease after anti-PD1 mAb will be defined according to RECIST v1.1.
2.3. Documented disease progression within 24 weeks of the last dose of anti-PD1 mAb.
3. Resolution/improvement of anti-PD1 mAb-related AEs
3.1. No history of common toxicity criteria adverse events (CTCAE) Grade 4 irAEs from anti-PD1 mAb.
3.2. No history of CTCAE Grade 3 requiring steroid treatment (>10 mg/day prednisone or equivalent dose) for >12 weeks or CTCAE Grade 2 pneumonitis regardless of steroid treatment.
3.3. Minimum of 4 weeks (washout period) from the last dose of anti PD1 mAb.
4. Prior treatment with an approved BRAF inhibitor if BRAF V600 mutation-positive.
5. Age = 18 years of age on day of signing informed consent.
6. Has a performance status of 0 or 1 on the ECOG Performance Scale.
7. Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. Lesion or lesions must meet all the following baseline criteria:
7.1. Accessible for electroporation,
7.2. Must be accurately measured in at least one dimension with a minimum size per RECIST v1.1.
8. Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 10 days of treatment initiation.
System Laboratory Value Hematological Absolute neutrophil count (ANC) =1.5 × 109/L Platelets =100 × 109/L Hemoglobin =9 g/dL or =5.6 mmol/L Renal Creatinine* OR =1.5 × the upper limit of normal (ULN) OR Measured or calculated creatinine clearance (CrCl) Glomerular filtration rate (GFR) can also be used instead of creatinine or CrCl = 60 mL/min for patient with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin =1.5 × ULN OR direct bilirubin =ULN for patients with total bilirubin levels > 1.5× ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × ULN OR =5 × ULN for patients with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT)
* Creatinine clearance should be calculated per institutional standard.
9. Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration.
10. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day study drug administration
11. Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
12. Able and willing to provide written informed consent and to follow study instructions.
Exclusion Criteria:
The patient must be excluded from participating in the trial if meet any of the following:
1. Patient has disease that is suitable for local therapy administered with curative intent.
2. Patient with a diagnosis of uveal melanoma.
3. Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
4. Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy or gamma-knife therapy with no evidence of progression, and have not required steroids, for at least two months prior to enrolment.
5. Greater than 3 visceral metastases. For patients with less than or equal to 3 visceral metastases, no lesion > 3 cm and liver lesions must meet RECIST v1.1 criteria for SD for at least 1 month prior to enrolment.
6. Patients with electronic pacemakers or defibrillators.
7. Patients who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
8. Patients who have known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected); Note: Patients who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study.
9. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
10. Patients who have received a live-virus vaccination within 30 days of the first dose of treatment. Seasonal flu vaccines that do not contain live virus are permitted.
11. Patient has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
12. Patients who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Cycle 1, Day 1 (baseline).
13. Patient has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
14. Patient has a history of interstitial lung disease.
15. Patient has an active infection requiring systemic therapy.
16. Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
17. Patient has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
Note: Patients with =Grade 2 neuropathy or =Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: If patient underwent major surgery or radiation therapy of >30 Gy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study combination therapy.
18. Participation in another clinical trial within 30 days of screening. Note: Patients participating in an observational study are an exception to this criterion and may qualify for the study with Sponsor approval
19. Patients who have had any chemotherapy, targeted small molecule therapy, radiation therapy or any immunotherapeutic after their confirmed progression on anti-PD-1 therapy.
20. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
21. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
Thank you.
$ELTP was very confident in the CC on Friday on the imminent FDA approvals.
Yes Percocet any day now and then followed by Norco.
Manonb I just lost a dear relative that was on Keytruda's mono-treatment. Most unfortunately this person was not a candidate for the Combo because the cancer had spread rapidly, as Keytruda mono-treatment was totally ineffective, and they now had less than 6 months to live. A requirement for the ONCS/Merck combo is that they must have at least 6 months to live to qualify.
Your Canadian friend should have their doctor call ONCS and ask to be included in a ONCS/Keytruda clinical trial.
http://oncosec.com/contact/
sharkey1 Both $ELTP Percocet and Norco 483 were site handling related. $ELTP has already responded with the requested implementation that the FDA requested. $ELTP is waiting now for the hard copy registered approval letters for both Percocet and Norco.
Good. Peace to you and GL
Frankly there is no way IMO to keep it as simple layman's language. Cancer treatment has progressed in the past several years to extreme complicated language and molecule description. As a Professional myself I am constantly challenged to keep up with the new finds as it requires close to 100% of time dedication.
staccani Be happy for the 57% PFS after 18 months for the ONCS/Merck combo.
There are many Melanoma trial types and each has its own strength.
As for your statement I agree.
zb19812013 Exactly correct!
$ONCS PFS Results 57% at 18 months
Stage IIIb and IIIc 14 (60.9%)
Stage IV M1a and M1b 4 (17.4%)
Stage IV M1c 5 (21.7%)
http://oncosec.com/wp-content/uploads/2017/11/ONCS-SITC-POSTER-2017_-1.pdf
This trial was designed By Merck, UCSF and $ONCS
Total nonsense your statement:
PFS Results 57% at 18 months P524 SITC
Progression free survival (PFS) rates for this
treatment were 62% at 6 months and 57% at 18
months (median PFS not reached at 24 months)
with a 48% BORR. DOR was not assessable as no
responders have progressed and no safety signals
were observed with only 2/22 grade 3 treatment-
emergent adverse events. In responding patients,
significant post-treatment increases were observed
in both the Th1-associated gene expression of
STAT4 and IL-12RB in biopsies, and frequencies of
CD8+
PD-1+
TIGIT+ and proliferating CD8+
PD-1+
peripherally. Additionally, responding patients had a
significant increase of TCR clonality in the tumors
compared to PBMCs with a reversed relationship in
non-responding patients. Spatial analysis by mIHC
revealed a significant increase of both PD-L1+ and
FoxP3+ cells <15um from CD8+ T cells in non-
responders. Exploratory analysis with Nanostring’s
IO360 Beta Version panels highlighted
underexpression of WNT2B and overexpression of
MICB in the pretreatment responder biopsies.
Conclusions
Durable responses and favorable PFS rates in likely
PD-1 non responders continues to suggest that
combination IT-TAVO-EP with pembrolizumab is an
effective therapeutic modality with an excellent
safety profile. Associated biomarker data highlights
connected immunological mechanisms, whereby
intratumoral Th1-polarization, associated TCR
clonality and limited suppressive cell types can drive
robust anti-tumor responses (intratumoral and
systemic) that positively impact this difficult to treat
patient population.
Trial Registration
NCT02493361
$ONCS NCT02493361
https://clinicaltrials.gov/ct2/show/NCT02493361?cond=NCT02493361&ran
Percocet and Norco, not the ADE SOPs
Most welcome.
The label would simply be a Pamphlet insert the same as Opana's IR oxymorphone
Opana IR oxymorphone
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10d4a5d9-9cb8-4dcf-9836-34c377990128#section-2
$ELTP's 163 person P3 bunionectomy trial with zero adverse events proves that Tmax was not a problem.
Tmax is simply a theoretical number for opioid naive persons that have zero pain and are fed a fatty meal!!!!!!!!
10-Q
14 references correct $0.1521
1 reference incorrect $1.1521
Typical
$ONCS new 52 week high > $2.55 Mon?
Regional Healthcare Contracting Office-Central, Brooke Army Medical Center intends to award a sole source contract with US Bioservices Corporation for MACI autologous tissue graft. US BioServices Corporation is the sole source provider of the Vericel MACI product to military medical facilities. Award will be made on or about 14 November 2017. The NAICS code 339113, size standard is 750. This notice is neither a request for quotes nor a solicitation of offers; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency for future requirements.
discussed previously. New Military contract using $VCEL MACI
$ONCS Fri AHs close $2.32.
The HOD Fri was $2.53.
The 52 week High is $2.55.
All of the Oxymorphones of +60 FDA approved drugs, IR and ER, NDAs and ANDAs, all have the FDA approved Pamphlet instructions to take on an empty stomach.
"One hr before a meal or two hrs after a meal"
That is why there is no comment in the Sept 30, 2017 10-Q. NH always waits for the official registered hard copy document letter before PRing to shareholders and SEC filing. He is however able to say it verbally in a CC call. My post on Thurs.
$ELTP always waits for the FDA offical registered letter before recording it as a Material Event.
Is some cases yes if financials control the decision. But most definitely not the case for acquiring or partnering with a company like $ONCS with their breakthrough EP+IL12 technology. Dan O'Connor will be contacting several BPs and time is of the essence to acquire/partner sensational $ONCS.
It is always that the Gov't is "slow" and that goes especially for the FDA. "Understaffed" always seems to be the case for Gov't agencies whereas Private Corporations doing the same "job" would be that they are "Overstaffed".
The Sept30, 2017 10-Q is simply stating the consequences of the site inspections noted by NH at Aug CC namely
Exactly. The reason is simply because the ADE SOPs, SOP 2810 (Version 3) and SOP 2805 (Version 7) are approved as is the NJ site handling facilities for the SOPs. $ELTP is now waiting for the official FDA clearance letter.
In the Sept 30, 2017 10-Q there is zero mention of any new CRL 483 for the ADE SOPs. In the Aug 2017 CC NH had noted that the FDA had stated that $ELTP had met all of the necessary requirements for the NJ Site's ADE SOPs. It can now be concluded that there are no additional issues and that $ELTP is waiting for the official FDA clearance letter for the ADE SOPs.
Good.
$4m for receivables already collected, plus $5.5m from ICT is registered in the 4th Qtr
$15 mil COH + $4mil + $5.5mil + (15-4 receivables =) $11 mil = $35.5 mil
"next three quarters".
$36 mil COH!! What is $VCEL going to do with all of the COH, a whopping $36 mil??????