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Lets get right into the model. The study was started in february 2009 and since then 89 patients has been enrolled in either the Carboplatin+Paclitaxel (CaP) or the Belinostat+Carboplatin+Paclitaxel (BelCaP) arm. In the artificial world this means that 44.5 persons have been enrolled in the BelCaP arm. It has been reported that the study was fully enrolled by the end of december 2010 which means that the recruitment rate for the BelCaP arm has been 2.02 per month assuming a constant recruitment rate (44.5 divided by the time elapsed from study start to the time when the study was reported fully enrolled). ...

Off-label use of drugs is not prohibited and originates from the idea that physicians should, based on their professional experience, be allowed to prescribe drugs not yet approved with the intention-to-treat. In the US, the requirement for off-label use of drugs is that the drug is on the market, i.e. approved by the FDA for some other indications (mainly due to safety reasons). Also, the law prohibits companies to promote off-label use. Anyway, the off-label use is widely practised and there are no reasons to believe that this will change in the nearest future. ...

In the recent analysis “TopoTarget - High Time to Double”, the target price was set to 7.5 DKr for the end of Q1 which was partly due to the belief that information regarding the ongoing PTCL study would be released. A few days ago, I submitted a question (through the Spectrum webpage) and received a rapid answer within a day, please read the respective e-mails below. “dear Sir/Madam, i would like to know whether Spectrum aims to publish interrim data for ptcl or not. perhaps an obvious question but as i havent found the information on your webpage im not sure that it has been explicitely expressed yet. ...

Topotarget is a biopharmaceutical company that is focused on the commercialization of its lead drug candidate, the anti-cancer agent Belinostat. Belinostat belongs to the class of Histone Deacetylase Inhibitors (HDACIs) and has had positive results for the treatment of haematological diseases and solid tumors. The main advantage over other HDACIs is its low toxicity and mild side effects, which allow treatment in large dosages, as well as the option to safely combine Belinostat with other anti-cancer drugs for the treatment of multiple diseases. Belinostat is currently being investigated in more than ten ongoing clinical trials both as monotherapy and in combination with other drugs. Although all of these are clinically interesting, the company outlook at the end of 2012 will almost solely depend on the results of two of these trials. ...

Belinostat - a Potent Anticancer Drug Demonstrating Broad Applicability TopoTargets drug pipeline comprises six different substances or families of compounds. Among these, Totect is the only one on the market and is approved for the treatment of tissue damage that may occur when a drug used for chemotherapy by accident goes into the tissue or leaks outside the veins. APO866, mTOR, Zemab and APO010 represent all drug candidates with substantial potential at different stage of development. Zemab for example, has shown promising efficacy in the treatment of breast cancer, a so-called blockbuster indication implying annual sales exceeding 1 billion US dollars (BUSD). However these candidates may well contribute significantly to the cash flow in due time, their potential with respect to development stage are dwarfed by that demonstrated by belinostat, TopoTargets lead candidate. ...

EpiCept (EPCT) har i likhet med många sektorkollegor misshandlats kraftigt på börsen de senaste månaderna och vid en första anblick uppenbarar sig ett företag med lovande pipeline och låg värdering (340 MSEK 20/8 2010) vilket är attraktiva egenskaper ur investerarperspektiv. En fördjupande läsning bekräftar detta; pipelinen med Ceplene i spetsen kan tillsammans med Azixa och NP-1 komma inbringa skapliga inkomster i storleksordningen av ett par hundra MSEK i sinom tid under förutsättning att den realiseras. Samma fördjupning sätter dock stora frågetecken till att detta någonsin kommer ske i EpiCepts regi; nuvarande kassa beräknas räcka in till q4 och EpiCept behöver totalt ta in kapital i storleksordningen av två årsförbränningar innan break-even kan nås och därför kommer EpiCept innan 2010 är slut antingen 1) ingå avtal med signifikant up-front 2) sälja verksamheten eller 3) emittera nya aktier. Med hänsyn taget till EpiCepts dåliga förhandlingsläge och ledningens milt sagt dåliga track-record är risken överhängande att eventuellt avtal eller försäljning kommer vara till motpartens favör, något som inte kommer gynna EpiCepts aktieägare i likhet med det sista alternativet nyemission som traditionellt sänker kursen. Rekommendationen blir därför sälj, det är en skyhög risk att potentialen inte kommer att realiseras. ...

TopoTarget är ett företag som utvecklar läkemedel mot cancer och har i dagsläget ett 20-tal pågående studier för sitt flaggskepp belinostat. Sett till stark ekonomiskt situation, befintligt avtal, samarbete med det amerikanska National Cancer Institute samt potentiella multimiljardmarknader för blockbusterindikationerna CUP och NSCLC har TopoTarget både en stark fundamental grund och potential till framtida mångmiljardintänker. Den senaste tidens icke-företagsspecifika utförsäljningar från den tidigare storägaren BankInvest har satt stor press på en redan lågt värderad aktie men i och med att resterande innehav bör vara på upphällningen är det läge att gå in med en viss reservation för det korta perspektivet. ...