uro spring cleaning update on where are the others and some stuff:
RNN Rexahn complete explaratory P1 rx-3117 oral bioavailability (TEVA)
https://www.4-traders.com/REXAHN-PHARMACEUTICALS-I-3064379/news/Rexahn-Pharmaceuticals-Inc-Rexahn-Pharmaceuticals-Completes-Exploratory-Phase-I-Clinical-Study-o-14447625/
but for pancreatic cancer AF said that data are full of red flags. There was some trouble before with this company.
https://www.thestreet.com/story/11681138/2/biotech-stock-mailbag-rexahn-vertex-peregrine-sarepta.html
thestreet article august 2012
know 2013
https://www.rexahn.com/cms/index.php/2013/02/rexahn-pharmaceuticals-provides-key-goals-for-2013/
Continue RX-3117’s clinical development with Teva Pharmaceuticals. RX-3117 is a proprietary small molecule compound that inhibits DNA methyltransferase and DNA synthesis and is being co-developed with Teva Pharmaceuticals for the treatment of cancer. In August 2012, Rexahn and Teva concluded a first-in-human clinical study of RX-3117. In the clinical study RX-3117 met its primary objective of determining the drug’s oral bioavailability in humans. The study supports RX-3117’s position as a potential future alternative to market leading anti-metabolite therapies in the treatment of solid tumors in the colon, lung, bladder and pancreas. As a result of this clinical study, Teva increased its ownership in Rexahn to 6.3%. According to the Research and Exclusive License Option Agreement and the Securities Purchase Agreement between Rexahn and Teva, the total money received from Teva to date is $9.1 million. Rexahn expects to receive additional milestone payments from Teva in the second half of 2013 with the submission of an IND and patient enrollment in a phase I clinical trial.
(SPPI) this is not done yet:
https://clinicaltrials.gov/ct2/show/NCT01410565
Last verified: August 2012
1/31/2013 8:32 AM ET
Biotechnology company Spectrum Pharmaceuticals Thursday said it reacquired rights from Allergan (AGN) to develop and commercialize apaziquone in the United States, Europe and other territories. This is in pursuant to an agreed-upon restructuring of Spectrum's collaboration with Allergan, which will be receiving royalty on future revenues of apaziquone.
Following a meeting with the U.S. Food & Drug Administration last month based on Phase 3 trials, Spectrum understands that the regulatory body can accept the NDA filing with the current Phase III and will likely convene an Advisory Committee meeting. Further, Spectrum has agreed to conduct one additional Phase III study following consultation with the FDA on its design.
https://www.rttnews.com/2047449/spectrum-pharma-buys-apaziquone-rights-from-allergan-to-file-nda.aspx
$200-300 million in peak annual revenue Spectrum hoped to generate from the drug.
https://www.thestreet.com/story/11487657/1/spectrum-pharma-the-growth-party-is-over.html
https://www.thestreet.com/story/11828564/1/spectrum-pharmas-bladder-cancer-bamboozle.html?puc=yahoo&cm_ven=YAHOO
The FDA has also already told Spectrum that an advisory committee will likely be convened to evaluate apaziquone. Plus, most importantly, Spectrum will need to conduct an additional phase III study.
I'm going to repeat that last part: Spectrum will need to conduct another phase III study of apaziquone. Let's remember: Two previous phase III studies failed.
P2 Drug: INSTILADRIN
FKD Therapies Oy
Completion 2014
Merck
As part of the deal, Merck has taken an equity stake in Parker's Finland-based start-up, FKD Therapies, which has reserves of $16 million, he said.
FKD will start developing the portfolio with an adenovirus designed to carry an interferon gene into the bladder wall cells, where it can express a protein.
Producing the protein within the bladder could increase its ability to penetrate tumour cells, Parker said, and a Phase I trial involving 14 patients had shown no tumour recurrence at three months for 43 percent of the patients.
https://www.reuters.com/article/2011/09/20/fkd-therapies-idUSL5E7KJ30O20110920
https://clinicaltrials.gov/ct2/show/NCT01687244
| Estimated Study Completion Date: | June 2014 |
another flop on Bladder cancer:
https://www.genomeweb.com/rnai/debiopharm-drops-out-bladder-cancer-deal-cash-strapped-marina
debiopharm, private company
Marina biotech(OTCPK:MRNA) might go bankrupt without extra funding
BUT
https://biz.yahoo.com/e/130212/mrna8-k.html
they found some funds
VIRALYTICS LIMITED (VLA)
Asx:vla
https://www.viralytics.com/
preclinical
https://www.swissbiotech.org/php5/aa2/index.php?1=1&id=472032
Warning Watch for conspiracy!
Telormedix’s current investors include:
- Aravis Venture (Basel, Switzerland)
- Proquest Investments (Princeton-San Diego, USA)
And for proquest investment:
Jeremy P. Goldberg served as Senior Vice President, Group Vice President and Managing Director, Corporate Development of Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc., since January 19, 2004. Mr. Goldberg was responsible for Endo's overall corporate development activities including structuring, negotiating and closing transactions such as the acquisition of companies, technology, products and product lines. He served as Group Vice President of Endo Pharmaceuticals Inc. since January 19, 2004. He joined Endo with more than 20 years of business experience, much of which was focused on investing and business development activities in the pharmaceutical and healthcare industries. Mr. Goldberg was a Founding Partner with ProQuest Investments, the first cancer-focused venture capital fund, where he and partners raised more than $250 million to acquire positions in biotechnology, specialty pharmaceutical, and medical device companies. He was Partner at ProQuest Investments IV, L.P.; ProQuest Investments III, L.P.; ProQuest Investments II, L.P. He was Founder of GPC Biotech Inc. He serves as a Director of ATI Medical Inc. He served as a Director of Eos Biotechnology, Inc., and Endo Pharmaceuticals, Inc. He serves on visiting committees at the Dana Farber Cancer Institute and UCSF (University of California, San Francisco) Cancer Center. Mr. Goldberg is a graduate of Harvard College and Harvard Business School.
End of warning
Telormedix enrols first patient for phase II in bladder cancer
Clinicaltrials.gov NCT01731652 https://clinicaltrials.gov/ct2/show/NCT01731652?term=NCT01731652&rank=1
https://www.stockwatch.com/News/Item.aspx?bid=U-prNY58417-U%3aOGXI-20130212&symbol=OGXI®ion=U
(OGXI)
OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer
https://clinicaltrials.gov/ct2/results?term=ogx-427&Search=Search
P2: estimated completion date: June 2014
https://www.4-traders.com/news/Theralase-Achieves-Commercialization-Milestone-For-Its-Bladder-Cancer-Therapy--16539081/
(TSXV:TLT)
Theralase will validate its PDC technology in this animal cancer model to support an Investigational New Drug (IND) application to be filed with the FDA later this year. This IND application will allow Theralase to commence a Phase 1/2a human clinical trial to prove the safety and efficacy of its PDC technology on a 30 subject population with scheduled completion in 2014. Based on recent pharmaceutical acquisitions for oncology drugs and market statistics, the estimated value of the PDC upon successful completion of a FDA Phase 1/2a clinical trial ranges from $84 million to $360 million in upfront payments followed by a double digit revenue royalty stream. (Source: BIO statistics)
Iressa market by Astrazeneca and Teva.
The title is: BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
https://clinicaltrials.gov/ct2/show/NCT00352079?term=gefitinib+bladder&rank=1
P3 Completed on January 2012. Iressa did not make it for NSCLC
This study has been terminated.
(terminated due to poor accrual)
https://www.pharmatimes.com/Article/13-01-23/Another_NICE_no_for_Javlor_cancer_drug.aspx
NICE is still not backing Pierre-Fabre’s Javlor for a certain type of bladder cancer that has spread to other part of the body.
Specifically, the watchdog has not recommended Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract, which has progressed following prior treatment with platinum-containing chemotherapy.
CELG
https://clinicaltrials.gov/ct2/show/NCT00583349?term=abraxane&rank=1
phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer
p1-2 completion date June 2013 last verified Nov2012, still recruiting
Biocancell with a P2 completion December 2012: last verified May 2012
https://clinicaltrials.gov/ct2/show/NCT00595088?term=bc-819&rank=3
https://www.aezsinc.com/en/page.php?p=60&q=519
aezs-108 preclinical
endo last fiasco
84 patients for the trials? Is this correct ?and it took 2 years for endo to ask FDA to change the protocol, really…
urocidin: Last updated: March 27, 2013
This study has been terminated. NCT01200992
(Lack of Recruitment)
https://clinicaltrials.gov/ct2/show/NCT01200992?term=mcc+endo&rank=3