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Oncotelic Therapeutics Inc. (OTLC)

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Last Post: 1/19/2022 11:52:47 AM - Followers: 16 - Board type: Free - Posts Today: 0

 

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Reverse Merged with MATEON THERAPEUTICS Formally MATN

Oncotelic – Welcome to Oncotelic

$11 Billion Target Markets - 100+ Patent Applications - 2 Key Clinical Programs - 30+ Years Experience

Mateon has three major business segments: 1) PointR- developer of vision grid/cluster computing/AI to support drug development. 2) Mateon/Oxigene- developer of Vascular Disrupting Agent (CA4P and Oxi4503). FDA granted CA4P rare pediatric designation for pediatric melanoma in 2020 and OXi4503 rare pediatric designation for pediatric ALL. 3) Oncotelic- developer of OT-101 - an antisense against TGF-beta- for the treatment of cancers. OT-101 completed phase 2 with good safety and efficacy against pancreatic cancer, glioblastoma, and melanoma. OT-101 also been granted rare pediatric designation against pediatric DIPG in 2019. OT-101 is also being deployed against COVID-19. OT-101 is in phase 2 clinical trial against COVID. We are also developing Artemisinin in phase 4 clinical trial against COVID. It is approved by India for symptoms frequently observed in COVID. It is being launch by end of 2020. Global launch will be soon after.

 

Oncotelic (formerly known as Mateon Therapeutics, Inc.) was created by the 2019 reverse merger with Oncotelic, which became a wholly owned subsidiary of Oncotelic, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2 and COVID-19. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.Oncotelic.com.

 

ARTIShield ™/ARTIVedaTM- an Ethnobiology Drug

Mateon is pursuing several avenues with respect to the development and commercialization of ARTIShield in the treatment of COVID-19. ARTIShield is Ayurveda - Dvipaantara Damanaka - and is labeled as a capsule containing Artemisia Powder 500mg. It is a demonstration of how Ethnobiology can be used to drive drug development against emerging pandemics.

The classical pharmaceutical regulatory pathways have failed to provide fast-track to treatment and vaccines. Government resources have concentrated on a few candidates most of which have failed. The Ayurvedic medicine route is proving to be an accelerated pathway to deploy a well-known, abundantly available and cost effective Ayurvedic medicine that is safe and being proven in-vitro and large-scale clinical trial to be effective.

ARTIShield /ARTIVeda - Commercialization in India

Mateon announced that ARTIShield /ARTIVeda has been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) in India for the treatment of various symptoms including fever and inflammation, which can be associated with COVID-19. ARTIShield is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India and is designed to be a readily available and cost-effective agent to combat COVID-19. ARTIVeda is the tradename for India and ArtiShieldTM is the tradename for outside of India. Mateon expects sales will commence in India before year end.

ARTI-19 Multi-national Phase IV Trial, Currently in India

Mateon announced the enrollment of its first patient in a Phase IV study ARTI-19, “A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19”. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. This is a global study with India to contribute at least 300 patients to the total aggregate of 3000 patients. We expect preliminary top-line data for ARTI-19 sometime between Q420 and Q121.

About OT-101

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).

TGF-β is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).

OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching

ArtiVeda/ArtiShield – a natural derivative from the plant Artemisia – Artemisinin has shown to be highly potent at inhibiting the ability of the COVID-19 causing virus to multiply while also having an excellent safety index. Artemisinin derivatives are used to treat malaria. More Information.

OT-101 – an antisense against TGF-β2 – for the treatment of solid tumors with focus on brain cancer in adult and DIPG in children. RPD for pediatric DIPG granted by US FDA. OT-101, also referred to Trabedersen, is a novel antisense oligodeoxynucleotide (ODN) developed by Oncotelic for the treatment of patients with pancreatic carcinoma, malignant melanoma, colorectal carcinoma, high-grade glioma (HGG), and other transforming growth factor beta 2 (TGF-β2) overexpressing malignancies (e.g., prostate carcinoma, renal cell carcinoma, etc.).

Trabedersen is a synthetic 18-mer phosphorothioate oligodeoxynucleotide (S-ODN) complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene. Cancers overexpress TGF-β, which suppresses host innate immune response to the cancers. Treatment with OT-101 lifts the TGF-β cloaking effect and allows innate or therapeutic immunity to attack and eliminate the cancers.

We have completed phase 2 for pancreatic cancer and melanoma, and phase 2 in glioblastoma with robust efficacy and safety.

OT-101 – an antisense against TGF-β2 –for the treatment of various viruses, including the SARS and the current COVID-19, on its own and in conjunction with other compounds.

CA4P – a vascular disrupting agent (“VDA”)- in combination with Ipilimumab for the treatment of solid tumors with focus on melanoma in adult and pediatric melanoma. On May 4th, 2020, FDA granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug for a “rare pediatric disease.”

Oxi4503 – a second generation VDA- for the treatment of liquid tumors with focus on childhood leukemia. US Food and Drug Administration (FDA) granted our request and designate OXi4503 (combretastatin A1-diphosphate; CA1P) for treatment of acute myeloid leukemia (AML) due to genetic mutations that disproportionately affect pediatric patients as a drug for a “rare pediatric disease”, as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ff(a)(3)).

could aggravate the disease through Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.

The development of OT-101 is important given the failure of other drugs leaving dexamethasone as the only clinically proven effective drug against COVID-19.

 

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#248  Sticky Note $MATN & $GILD?????,6;41a.m. 07-07-2020 .M. Mateon Therapeutics Appts. mick 07/28/20 06:25:22 PM
#896   Oncotelic Presenting at BiotechGate Digital Partnering: https://finance.yahoo.co mishe 01/19/22 11:52:47 AM
#895   $OTLC Oncotelic Initiates Phase 1 Trial Evaluating CA4P TommyBoyTrader9460 01/11/22 01:45:08 PM
#894   .19's starting to chip away now Screech691 01/10/22 11:46:14 AM
#893   Thinking the same..chart has been on the climb.. TommyBoyTrader9460 01/10/22 11:22:09 AM
#892   wouldn't be surprised if it was a fake Screech691 01/10/22 11:21:17 AM
#891   $OTLC .19 up with a wall..watching for a TommyBoyTrader9460 01/10/22 11:15:37 AM
#890   looks like we've got the loading block at Screech691 01/10/22 09:40:34 AM
#889   $OTLC bidders at .18 now..continues to gain strength.. TommyBoyTrader9460 01/07/22 04:00:45 PM
#888   agreed, just need that dumb seller at .19 Screech691 01/07/22 02:20:41 PM
#887   Yeah a lot of the OTC is pretty SpaceManTrades 01/07/22 12:36:59 PM
#886   Quiet trading day..chart still holding strong.. TommyBoyTrader9460 01/07/22 11:40:02 AM
#885   $OTLC Low Float play, moves on air.. PennyMaster 01/07/22 10:28:29 AM
#884   I don't see any resistance at all on SpaceManTrades 01/07/22 09:10:48 AM
#883   $OTLC next leg up on the chart starting, Screech691 01/07/22 08:42:13 AM
#882   $OTLC Trading very well here..cross the 200 day TommyBoyTrader9460 01/07/22 06:05:22 AM
#881   $OLTC impressed with today..as .17 broke through TommyBoyTrader9460 01/06/22 03:49:15 PM
#880   Why 2022 Could Open Gangbusters for Covid Stocks PennyMaster 01/06/22 03:42:47 PM
#879   $OTLC Breakout is imminent imo.. PennyMaster 01/06/22 03:41:33 PM
#878   $OTLC .185 up! TommyBoyTrader9460 01/06/22 02:38:19 PM
#877   $OTLC looks ready for the next leg up Screech691 01/06/22 02:37:43 PM
#876   $OTLC got my eyes on these bidders..keep moving up… TommyBoyTrader9460 01/06/22 01:02:46 PM
#875   business is picking up here! .185's almost gone Screech691 01/06/22 11:12:01 AM
#874   $OTLC Volume picking up..looks like we finally see TommyBoyTrader9460 01/06/22 10:57:46 AM
#873   $OTLC Oncotelic Initiates Phase 1 Trial Evaluating CA4P PennyMaster 01/06/22 10:35:54 AM
#872   nice to see this pop over .18 today Screech691 01/06/22 10:25:34 AM
#871   Looks like it's trying to form a cup SpaceManTrades 01/06/22 10:24:06 AM
#870   $OTLC strong start here! Bidders moved up over TommyBoyTrader9460 01/06/22 10:08:38 AM
#869   Definitely a steal at this price. Almost criminal. SpaceManTrades 01/06/22 09:54:53 AM
#868   Absolutely..looking forward to what they are bringing to TommyBoyTrader9460 01/06/22 08:58:36 AM
#867   this stock reminds me of some nasdaq biotechs Screech691 01/06/22 08:52:52 AM
#866   that's usually how these biotechs operate, don't want Screech691 01/06/22 08:52:05 AM
#865   Thinking we might see an update leading in TommyBoyTrader9460 01/06/22 08:47:52 AM
#864   Two drugs going through clinical trials. One for SpaceManTrades 01/06/22 08:46:28 AM
#863   news looked good, they have lot of simultaneous Screech691 01/06/22 08:40:49 AM
#862   Love this from the news yesterday… TommyBoyTrader9460 01/06/22 06:25:44 AM
#861   $OTLC Really wants that .20 test here! TommyBoyTrader9460 01/05/22 02:12:53 PM
#860   For being a light volume day it's trading SpaceManTrades 01/05/22 01:51:36 PM
#859   $OTLC looks like it wants to POP soon! PennyMaster 01/05/22 12:58:56 PM
#858   big conference presentation Jan 25-27 for OTLC, there Screech691 01/05/22 12:58:35 PM
#857   spread just closed up, looking thin for a Screech691 01/05/22 12:58:08 PM
#856   something about that .17 just doesn't want to Screech691 01/05/22 12:05:14 PM
#855   I think we'll have a good afternoon here. SpaceManTrades 01/05/22 11:36:30 AM
#854   $OTLC looks like just a little more buying TommyBoyTrader9460 01/05/22 11:34:19 AM
#853   $OTLC .17 just cleared out..on watch for breakout now.. TommyBoyTrader9460 01/05/22 10:12:04 AM
#852   Oncology drug development conference on January 25th thru SpaceManTrades 01/05/22 10:01:33 AM
#851   $OTLC Huge News out!! Oncotelic Initiates Phase 1 PennyMaster 01/05/22 09:55:57 AM
#850   Nice results! Screech691 01/05/22 09:49:09 AM
#849   $OTLC last of .17 falling as bids are stacking.. TommyBoyTrader9460 01/05/22 09:34:28 AM
#848   $OTLC News just out! TommyBoyTrader9460 01/05/22 09:22:45 AM
#847   Just saw that news. Nice https://finance.yahoo.com/news/oncotelic-initiates-ph Crunch1 01/05/22 09:21:11 AM
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