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Friday, September 22, 2017 2:55:55 PM
First, we see many posts that sort of simplify things to "Where is PMCB's cure for pancreatic cancer?"
$PMCB hasn't developed a new drug to combat pancreatic cancer. Instead, it has taken cells that produce an already FDA approved chemotherapy drug, ifosfamide, and encapsulated them using Austranova's IP in cellulose-based capsules that are unique in that they cause no immune response from the body.
Encapsulated cells create what's called a biologic, and in this case trademark protected under the name Cell-in-a-Box or CiaB. CiaB allows for injectable, targeted chemotherapy, versus traditional IV chemotherapy. Because IV chemotherapy is circulated throughout the entire body, it naturally has many horrible side effects.
At this stage of the game $PMCB is offering big pharma a delivery system for already approved drugs. The nice thing about this is prior safety and efficacy studies can be relied upon. The other nice thing is cost. Finding a new drug to treat pancreatic cancer would likely cost between $2-$10 Billion dollars. Instead, we are taking what has been proven to work in the past and making it better. Smaller, better targeted doses.
Better for the patients and better for the company. Better for the patients because of smaller does of, in this case, ifosfamide, which means fewer side effects. Better for the companies, because the new biologic will have market exclusivity for 12 years. Remember, market exclusivity for a brand new drug is generally 5 years.
If you take a look at the long list of chemotherapy drugs owned by a company like J&J, you see names like CAELYX (doxorubicin hydrochloride), which went generic in 2013, and is used to treat cancer of the ovary or breast. This drug is still produced, but as a generic brings in modest revenue.
I have no idea if cells can even be created to produce doxorubicin hydrochloride, but bear with me here. For a relatively modest investment (the millions required for testing, IND submission, phase 2b trial) J&J could end up with a new CiaB biologic to target solid ovary and breast tumors that would have a 12 year market exclusivity.
So, you have that on the one hand and on the other hand the sobering reality that it would require between $2-10 Billion dollars to develop a new drug to target those cancers. $2-10 Billion for a market exclusivity of just 5 years.
J&J has several chemotherapy drugs off exclusivity now and they have more coming off in 2018 and beyond.
IF $PMCB has a successful phase 2b for pancreatic cancer, I strongly believe big pharma will want to try to replicate the success of CiaB and ifosfamide with countless other chemotherapy drugs.
Is that going to happen tomorrow? No. But I believe we are at the cusp of the most important moment in $PMCB's history.
I believe in the science and I believe in the math (that it's more cost effective to pursue new biologics than seek new drugs). Most importantly, I believe in the team KW has assembled, most importantly Dr. Manuel Hidalgo our Principal Investigator and most recently Dr. Sher our new CMO.
Know What You Own. My posts should not be construed as investment advice.
Recent PMCB News
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/30/2024 08:05:04 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 05/30/2024 08:05:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 08:40:20 PM
- PharmaCyte Biotech Makes $7 Million Strategic Investment in MyMD, A Biopharmaceutical Company Focused on Inflammatory Disease • Business Wire • 05/21/2024 01:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:38 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 02:56:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 12/15/2023 10:25:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/24/2023 09:00:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:02:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:02:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:00:10 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 11/22/2023 09:00:15 PM
- PharmaCyte Biotech Acquires $5 Million Stake in Emerging Women’s Health Innovator Femasys, Inc. • Business Wire • 11/15/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 10:25:09 PM
- PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology • Business Wire • 10/31/2023 01:15:00 PM
- PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology • Business Wire • 10/31/2023 01:15:00 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/21/2023 09:04:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 09/18/2023 10:04:06 AM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 09/15/2023 09:00:03 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/12/2023 01:56:25 AM
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