Bennett and other IDPH investors,
I still feel that IDPH is on the move. Perhaps today's action is a prelude. With biotechs picking up and with IDPH being undervalued at the moment, I feel a move is imminent. How about a prediction: we will see a move of several points, say to $23+, over the next week or so.
I was interested today to see Idec mentioned in several biotech newsletters. I saw in Jan. Clinical Investigator News that Idec filed to the FDA (the PMA) for approval on C2B8. It is for single-agent therapy for follicular non-Hodgkin's lymphoma.
I was unaware that this had occurred yet. Of course, I expect it, but I haven't seen it before. This means that everying is right on track, in fact, perhaps ahead of schedule. Since accelerated review will be given, we could see approval in 6 mo or so. Note that as a typical rule, the street values companies about this much time down the road.
On a different note, I saw in January Clinical Trials monitor the protocol for the CE9.1...I will type some of it in (I am sorry about typos...)
Idec-CE9.1 (SB210396)
Sponsor:Smithkline Beechman Pharmaceuticals
Phase:III
Location: Multicenter in US, Canada, and Europe
Status: Smithkline Beecham has begun Phase III trials of Idec CE9.1 (SB210396), an anti-CD4 antibody for the treatment of rheumatoid arthritis. In the first randomized, double-blind protocol, 500 patients are assigned to recieve four weeks of induction therapy with intravenous Idec-CE9.1 at 80 mg twice weekly or 240 mg one a week or placebo. Subjects are given three additional treatments over the next five months as maintenance therapy. The endpoint is effects on the signs and symptoms of rheumatoid arthritis as defined by the American College of Rheumatology (ACR) 20 guidelines, which require at least a 20% improvement in tender and swollen joints as well as improvements in three of five other disease-elated parameters. Disease progression will also be monitored. In a completed Phase II study, 122 evaluable patients were given 40, 80, or 140 mg Idec_CE9.1 or placebo twice a week for four weeks. ACR 20 response rates were 42%, 47%, 77% and 17%, respectively. At the highest dose level, three of 16 patients experienced mild or moderate rashes, propting the modification of dosing for phase III. Smithkline is planning a total of six Phase III protocols, including evaluations of patients withdrawn from DMARDs (disease-modifying anti-rheumatic drugs) such as methotrexate and corticosteroids, patients concurrently taking methotrexate and for prevention of structural damage. Idec-CE9.1 is a Primatized - componenets anti-CD4 antibody. It was developed by Smithkline's partner Idec Pharmaceuticals Corp. (SanDiego,CA) Details: John Lipani, group dir.-inflammation and tissue repair, Smithkline Beecham Pharmaceuticals, 1250 S. Collegeville Road, PO Box 5089, Collegeville, PA 19426-0989 Fax: 610-917-4100
Several things struck me about this. First, the trials are being conducted in an excellent manner with well-defined endpoints, sometimes a difficult task (especially for a relatively subjective disease like arthritis) which can hold up or even
preclude approval. Next, Smithkline is cover a lot a bases here.
For example, there are many patients, 6 different protocols, and it is multinational. This must be an expensive trial for them , so obviously they expect a high return here. By the way, Idec themselevs could never afford such a trial; this is the beauty of their relationshipo with SKB - SKB takes all the financial risks
and both Idec and SKB reap the rewards.
I originally invested in IDPH for its CD20, but the more a read about CE9.1, the more I am optimistic about this drug candidate also. It sounds like the trial will not be complete until about the summer. Imagine the double whammy of both C2B8 approval and positive Phase III for CE9.1 occurring this summer!
Rick |
