Pharmacyclics Scores on Non-Hodgkins Lymphoma Data (PCYC)
Pharmacyclics Inc. (NASDAQ: PCYC) is seeing shares surge today after it said that its Phase 1/2 trial of motexafin gadolinium plus antibody targeted radiation therapy demonstrated a high complete response rate in patients with non-Hodgkin’s lymphoma. The results of the study showed a 46% complete response rate in patients with multiply recurrent non-Hodgkin’s lymphoma who were treated with motexafin gadolinium in combination with Yttrium-90 Ibritumomab Tiuxetan, an approved antibody-targeted radiation therapy.
Patients were treated with a standard dose of Zevalin administered with 2.5 to 5.0 mg/kg of MGd given for six days. Of the 28 evaluable patients in the study, 46% showed a complete response and 11% more showed a partial response. Rituximab refractory patients showed an overall response rate of 86%, with a 64% complete response rate and a median time to progression of 14 months.
Adverse events seen were related to bone marrow suppression, an expected side effect of treatment with Zevalin.
This data was part of a presentation at the International Conference on Malignant Lymphoma. Shares are up some 19% at $1.25 today on more than 5-times volume. Its 520week trading range is $0.55 to $3.28 and its market cap is a mere $32.5 million even after the run. As of last quarter, it had roughly $21 million in liquidity from cash and equivalents.
Jon Ogg
June 5, 2008
Public Awareness Needed Before Vaccinating Girls with Merck’s Gardasil
by Mark S. Senak
EyeOnFDA.com
Last week, Governor Rick Perry (R-Texas) decided on a bold move when he announced an Executive Order mandating the vaccination of girls with Merck’s (MRK) new anti-HPV vaccine Gardasil. By itself, this news would be interesting. A governor so interested in public health, that he or she bypasses all other regulatory and legislative channels with an Executive Order would be newsworthy. But in this case, there is controversy.
Here is the background. Gardasil was approved last year in June, 2006 by the FDA as the first vaccine to prevent cervical cancer in women by building immunity to human papillomavirus - the most common sexually transmitted infection in the United States. The vaccine is given to young girls because it is most effective if administered prior to any HPV infection. Planned Parenthood has advocated for widespread vaccination. According to the Washington Post coverage - “The most effective vaccination programs are either given to young children or are mandated for attending school,” said Jeffrey Waldman, senior director for clinical affairs for Planned Parenthood Federation of America. Rarely does one expect to find Planned Parenthood and a conservative Republican governor of a southern state in bed together.
But some people disagree with them. Their logic (or lack thereof, depending on your point of view) echoing back to the needle exchange/condom availability controversy in HIV/AIDS prevention, is based on the belief that the vaccine will encourage or condone sexual activity. But some of the outrage directed at the Governor, by such organizations as The John Birch Society are based on the fact that some perceive the move by the Governor not to be out of public health concern, but due to lobbying by the drug’s manufacturer, Merck. In fact, apparently one of Merck’s Texas lobbyists is in fact Governor Perry’s former chief of staff.
Coverage of this issue in the media or the blogosphere generally takes note of the fact that Merck is actively lobbying in other states for mandatory coverage. Without getting into the merits of requiring the vaccination, the sudden emergence of this situation in Texas points to the need for a delicate balance between direct lobbying and public affairs efforts. In this case, it is important that parents have a full understanding of the complexities of the problem between HPV and cervical cancer, along with rates of sexual activity among teens. In that way, they understand the problem so that when the solution presents itself, by whatever mode, it has a higher level of acceptance.
I’m not saying that Merck has failed to consider the balance between lobbying and public affairs in advocating for immunization. I have no insight into their public education efforts in Texas and have no other facts at hand. But judging by some of the coverage, it is possible to consider that the governor of Texas provided a solution to a problem before many were even aware of the problem. Educating the public after the fact is much harder. While public health advocates may cheer, if people perceive big pharma is pushing solutions on them before they want them through intensive lobbying efforts and campaign contributions, the value of the geniuine public health contribution being made by a drug like Gardasil can be easily overshadowed by resentment. That does neither Merck or the pharma industry any good. It is essential that public relations communicate before lobbying activates.
By the way, anyone interested in contacting Governor Perry about this decision can do so through this link.
(This article was published by BioHealth Investor with permission of Mark S. Senak, author of EyeOnFDA.com)
RELATED READING:
- The New FDA Drug Safety Initiative
- Merck Wants Out of Pfizer’s Shadow
- Merck Putting Vioxx Behind It
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