Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) – 52% Rate of success in Hepatitis C patients taking Telaprevir.

ABOVE: Vertex stock chart over the last 3 Months

06/09/2008: Vertex Pharmaceuticals (Nasdaq: VRTX) announced that telaprevir-based regimen decreased virus blood levels in certain patients with hepatitis C(HCV) that failed previous treatment with the the standard Hepatitis C therapy.
Approximately 4.5 million Americans are estimated to be infected with Hepatitis C, 80% will most likely develop some form or chronic lIver disease. The annual health care cost for patients in the US that develop health issues from hepatitis C is a staggering $9 billion.  Vertex will be poised to make several 100 million dollars in revenue if Telaprevir becomes a viable treatment for Hepatitis C.  In addition, Telaprivir based treatments may also significantly decrease the cost of treating patients with Hepatitis C if Liver Transplantation can be averted.
Vertex will initiate a Phase 3 Clinical Trial of Telaprevir in the 3rd quarter of 2008.  Assuming that Telaprivir continues to be successful, the phase 3, 48 week trial will be the last stepping stone before Telaprivir goes on the market.  Thus, the drug may be released late in 2009 or possibly early in 2010.
VRTX closed on June 6th at 32.24 and it subsequently opened higher at 34.48 on June 9th.  The 52 week range for VRTX ranges from 13.84 – 41.42.  It is difficult to say if this stock will continue to increase at this piont.  Its current price is toward inching up towards its 52 week high.  It may be prudent to wait until the results of the Phase 3 Clinical Trial on Telaprivir are known which should be available in 2009.  Nonetheless, as a potential investment VRTX has significant potential.  As a trader, one may want to consider shorting this stock as it approaches its 52 week high if there is no further good news forth coming in the near future.

Merck (NYSE: MRK) & ZymoGenetics (NASDAQ: ZGEN) – Begin Phase II/III Clinical Trial for Lupus Drug

ABOVE: MRK Stock Chart over last 3 Months.

ABOVE: ZGEN Stock Chart Over Last 3 Months.
Germany 06/05/2008

Merck (NYSE: MRK) announced that it is partnering with ZymoGenetics, Inc. (NASDAQ: ZGEN) and they have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE).

There are 1.5 Million Americans with Lupus (SLE) with an annual health cost of appproximately 9 billion dollars.  If the trial is successful the revenue for both MRK and ZGEN might be several billion dollars when atacicept hits the market.  Assuming that Atacicept gets approved by the FDA it could be on shelves as soon as mid 2010.

Partly because of the recent decrease in stock prices (Dow down nearly 400 pionts, June 6th), both MRK and ZGEN decreased in price.  MRK’s 52 week range of stock price varied from 36.80-61.62, on June 6th it was down 1.40 and closed at 37.49.  Therefore, MRK is near its 52 week low and this may represent a good chance to buy and establish a long position as an investor.  As well, ZGEN has ranged from 8.09 to 16.28 over the last 52 weeks and it also closed down .50 on June 6th at 8.51.  As with MRK, this may be a good time to go long and buy ZGEN as an investment.

GlaxoSmithKline (NYSE:GSK) – Continued Good News for ASCI

ABOVE: GSK Stock Chart

GlaxoSmithKline (NYSE:GSK) – Continued Good News for ASCI

(Data Released 5/30/2008)

New data presented by GlaxoSmithKline (NYSE:GSK) emphasized the possible promise of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI).  MAGE-A3 results were presented within three studies evaluating highly targeted immunotherapy as a treatment for metastatic melanoma and non-small cell lung cancer (NSCLC). This amalgam of data was presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting. 

A randomised, open label (not blind) Phase II study designed to evaluate two different formulations of the MAGE-A3 ASCI in patients with metastatic melanoma has been conducted.  ASCI is a composite of MAGE-A3 recombinant protein and a GSK Adjuvant System.  ASCI was evaluated and the numbers suggest the possibility of a salutary clinical response.   The capacity of this study to reveal meaningful use for ASCI is limited because of its design.  However, if the aforementioned study is taken together with the positive findings in the, double-blind, placebo-controlled Phase II study as well as the subsequent creation of the current Phase III safety and efficacy trial in MAGE-A3-positive NSCLC patients (stage IB, II and IIIA), then the data is encouraging.

I have engaged in scientific research throughout my career in medicine.  As well, I am an American trained physician that practices medicine and has also engaged in clinical research.  However just as important, I am a successful real estate and stock investor.  In my opinion, the data presented about ASCI appears to be favorable.  GSK may very well increase its profitability through the success of ASCI in the market place.

Immunomedics, Inc. (Nasdaq: IMMU) – Veltuzumab: Non-randomized results for Phase II Clinical Trial

ABOVE: IMMU’s Stock Chart.

Immunomedics, Inc. (Nasdaq: IMMU) announced that veltuzumab mounted a comparatively high complete response rate of 27% in patients with follicular lymphoma, and that such results were achieved even when given at doses about 75% lower than rituximab’s (a rival agent) approved dose.

 The results were obtained from an open-label (non-randomized, not blinded), multi-center, Phase II Clinical trial in which 82 adult patients with Non-Hodgkin’s Lymphoma (NHL), most of whom had relapsed after prior therapies. 

I have engaged in scientific research throughout my career in medicine.  As well, I am an American trained physician that practices medicine and has also engaged in clinical research.  Although this study seems impressive, in my opinion, it is not. 

IMMU may very well have a good therapeutic premise in developing therapeutic antibodies.  In addition, veltuzumab may prove to be an effective treatment for lymphoma but this study does not prove it.  First of all, this study is open label and not “blind”.  In an open label (not blind, non-randomized) study the people that are administering the drug know that it is an experimental agent.  Open label studies induce bias because the personnel that are giving the drug may act differentially than they might act if they were dispensing a placebo.  Moreover, the fact that many of the study subjects were previously treated brings in the question what is being tested?  Are you testing the response of veltuzumab in treating lymphoma or are you testing the response that both agents have on lymphoma?  Is there a cross reaction or a temporal relationship that allows veltuzumab to be more effective after a patient has been treated with rituxmab?

I would continue to watch this stock for upcoming results on Phase III, randomized, clinical trials before assuming that Veltuzumab will increase IMMU’s bottom line.