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Posted On: 12/09/2019 10:03:22 AM
Post# of 145915
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Re: Cytodynamite #12207
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That was at least the reactions I experienced when I tried to tell others about this company. A company being able to cure or at least treat HIV, Cancer, NASH etc sitting on OTC and being worth only $200m. *lol*
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As you said more than 800 patients with no side effects, no metastasis in cancer, shrunk tumor.....I mean that's real.
I see some issues with your sales pitch. Leronlimab doesn't cure HIV, Cancer or NASH. Leronlimab has side effects. There is an animal study that has yet to be published where we suspect leronlimab was used in connection with other techniques to cure monkey of SIV, but it blocks HIV from entry into the new cells. Cells already infected with HIV, leronlimab can't help. It can block the VL they produce from infecting other cells. This is maraviroc's downfall, those cells already infected can create a new mutated version on HIV which can infect cells maraviroc protects. Then this new version takes over. With leronlimab, it blocks essentially all r5. So any new mutations can't take hold. With patients on mono p2 trial that failed, they checked to make sure the virus had not mutated, and it hadn't, no chance with rebound group from start to after rebound, which is very very important if they want mono approval.
from mono paper, https://www.ncbi.nlm.nih.gov/pubmed/29676212
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There was no significant change in viral susceptibility to PRO 140 in virologic rebound and non-virologic rebound groups of patients assessed by post-treatment IC50, and IC90 values when compared with pretreatment baseline values. This indicates that the ligand-receptor recognition profile of the CCR5 co-receptor was not altered during the course of the study. In addition, no changes in HIV-1 co-receptor tropism following virologic rebound were seen. PhenoSense® Entry results for PRO 140, maraviroc, and AMD3100 showed no significant change in post-treatment IC50, and IC90, compared with baseline results in virologic rebound patients. However, there was a noted difference in the IC90 values from virologic rebound (10.8+/−9.28) and non virologic rebound (6.7+/−6.groups on entry analysis indicating that more PRO 140 was required to reach IC90 by the group that was destined to rebound on PRO 140 monotherapy.
Leronlimab has been proven in combo, the p3 trial is over with over 80% efficacy at 24 weeks, with the previous approved drugs in the same unmet need area hit around 40%.
Leronlimab mono is pulling good numbers, but still needs a p3 trial. This being approved doesn't help BP's bottom line already in HIV. They are happy to sit back and watch cydy do all the heavy lifting, knowing they can step in at the end and take over, especially if the market cap continues to stay this low.
Leronlimab has only one patient with tnbc so far, historically about 3% (I believe) of phase 2 cancer drugs make it to approval. I'm very exited even with the low success rate of the past in other drugs, because there is 20 years worth of research connecting ccr5 with cancer, hundreds of papers, researchers all over the world. And a p1 trial in maraviroc already with positive results.
Leronlimab in nash, not as many papers, not even close with nash and ccr5, then comparing cancer with ccr5. So I'm not as convinced here as with cancer. It not to say it doesn't work, just the cancer research is very solid connecting ccr5 and rantes and ccr5 antagonist to aiding cancer.
All drugs have side-effects. Leronlimab has no SAE, serious adverse events in over 800 patients (no life threatening events due to the drug). That is rare in HIV and cancer. Few people taking leronlimab have reported mild injection site reaction, but these usually that goes away, and no one has stopped the trial. Also similar to placabo percentages, headache, nausea, and diarrhea has been reported, again mild that goes away, possibly no connection, but might be listed as possible side effects I am guessing. But nothing compared to the side-effects some people are experiencing with other haart drugs, which is why I feel people will gravitate towards the drug with fewer side effects.
Here is safety comments in combo poster
https://content.equisolve.net/_f8eaae214fb1b6...c8e1bd.pdf
Generally well-tolerated
No discontinuation due to AEs
No pattern of toxicity
Administration-site reactions were infrequent, mild, transient, and self-resolving (in <10% of subjects)
No dose-limiting toxicity in preclinical or clinical studies
But here is from the mono poster
https://content.equisolve.net/_f8eaae214fb1b6...c8e1bd.pdf
Overall,the majority of AEs were considered mild in nature and there were no patterns of drug-related toxicities observed.
Approximately 95% of injection site reactions were mild in intensity and considered to be self-resolving
No dose proportional increase inincidence and severity of AEs were reported with higher doses of PRO140(leronlimab).
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