Interim data from 60 patients in CTIC’s Phase II/III RAPID trial to treat relapsed, aggressive non-Hodgkin’s lymphoma (NHL) showed comparable major response rates and reduced toxicity in patients given CTIC’s pixantrone instead of doxorubicin. The open-label, international trial is enrolling 280 patients and is comparing CPOP-R (pixantrone with cyclophosphamide, vincristine, prednisone and rituximab) with CHOP-R (doxorubicin with cyclophosphamide, vincristine, prednisone and rituximab). Additional data will be presented in December at the American Society of Hematology meeting in Atlanta. Pixantrone is an aza-anthracenedione DNA intercalating agent. Biogen Idec (BIIB) and Genentech (DNA) market Rituxan rituximab in the U.S., while Roche (SWX:ROG) markets it elsewhere as MabThera. On Wednesday, CTIC was up $0.16 to $4.52.
DEPO fell $2.93 (59%) to $2 on Tuesday after once- and twice-daily doses of Gabapentin GR missed the primary endpoint of significant reductions in average daily pain scores vs. placebo in a Phase III trial to treat patients with post-herpetic neuralgia (PHN). In the double-blind trial in 407 PHN patients, pain reductions from baseline were 1.83 for patients receiving Gabapentin GR once daily; 1.72 for patients receiving the compound twice daily; and 1.43 for the placebo group. DEPO said there was a high placebo effect in the 10-week trial. The once-daily Gabapentin GR arm did meet secondary endpoints of significantly improved sleep interference scores, clinical global impression of change (CGIC) and patient global impression of change (PGIC) vs. placebo. Gabapentin GR is an extended-release gabapentin utilizing DEPO’s AcuForm Delivery technology.
Novacea(NOVC) shares soared 70 percent this morning on the news of a particularly rich commercialization pact.Schering-Ploughhas agreed to pay $60 million up front and take a stake in Novacea in exchange for commercialization rights to Asentar, a prostate cancer therapy currently in a late-stage trial. In addition, Schering-Plough has agreed to a $380 million schedule of pre-commercialization milestone payments and tiered royalties. Asentar is an oral formulation of calcitriol, a hormone that exerts its effects through the vitamin D receptor. Schering-Plough will pay for new research to determine the use of Asentar at earlier stages of the disease.
Novacea also has AQ4N in their pipeline, a tissue-targeted cytotoxic prodrug for the treatment of solid tumors.
Biovertisis a privately-held, Austrian biotechnology company focusing on the development of novel classes of small molecule antibacterials for serious hospital-based infections. Their lead product is an antibiotic called Oxaquin which wasacquiredfrom a company called Morphochem in 2005.Oxaquinclaims to have dual therapeutic properties of both quinolones and oxazolidinones with an improved antibacterial and safety profile.
Oxaquin entered into Phase 1 clinical trials in 3Q06 which was probably safety studies, single and escalating doses. At this point, the drug is not worth much to potential licensees or pharma partners as it has to move further along to show that it actually works in patients with a bacterial infection (not just healthy volunteers). Because the company is private and the information and all preclinical and clinical results are propietary, we can not say what exactly the status of Oxaquin is. However, if it made through Phase 1 then I would imagine that a Phase 2a is in planning right now, probably somewhere in Europe.
As for financing, the company has raised €21 million to date, including investments byTVM CapitalandLife Sciences Partners(LSP) as well as an atypical silent partnership provided by the Kapital & Wert Group, an Austrian corporate finance specialist. My guess would be that they are in the midst of a formal Series B as we speak, assuming the Phase 1 went well.
As for the rest of their pipeline, they have some very early Topo IV inhibitors…not too interesting.
Ultimately, Oxaquin won’t prove to be of any value for a while, but given the market potential and therapeutic rationale, I’d have to say I’m neutral.
1. Pre-treatment analgesia or
2. Plastic and cosmetic surgery procedures (liposuction, dermabrasion, hair transplant, etc)
…then maybe this might interest you. A company in Australia called Medical Developments International (MVP) is touting a product called Penthrox. Penthrox is the brand name for an anesthetic agent called Methoxyflurane which is inhaled prior to small surgical-like procedures, sedation or during minor emergencies. Inhalational Methoxyflurane was actually available in the United States many years back, but removed from the market because of nephrotoxicty (it was harmful to kidneys).
Apparently, MVP is trying to register the product with the US FDA and plans to conduct full-scale clinical trials to get it approved once again. They even filed for patent protection , but I doubt if they will be able to get an issued patent here in the States given the prior art. For patent novices, this means you can’t get an issued patent if a discovery was already made or known. In this case, we, the general public, already know that Methoxyflurane can be used for pain since that what it was used for many years ago.
Still, MVP is already commercializing Penthrox in Australia (as well as in many other countries where healthcare rules aren’t as stringent) where it is quite popular in ambulance and emergeny settings. In 2006, MVP generated Penthrox sales of almost $4,000,000. In fact, MVP is publicly traded on the Australian Stock Exchange and closed yesterday at $0.5050 with a volume of 230,300, up a mere $0.01. Still Crap.
If you check out MVP’s broker presentation on their website, you’ll read that they have already met with the FDA about re-introduction into the US. Bad. I think the amount of animal toxicity and safety data they will have to generate to get a US IND will be much more than their little measly Market Cap can handle. Definitely will need a licensing deal or partner. Plus, they will have to compete in a market that is saturated with safer, tried and tested agents. Besides, the real test is convincing the FDA and the docs to use it. If there’s no advantages, then docs and patients won’t take the bait. And neither will investors.
Want more on Penthrox?
Anesthesiologist? Nurse? Dentist? Paramedic?- Penthrox Information for Physicians
Patient?- Penthrox Information for Consumers
Investor?- MVP Broker Presentation
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