Shares of clinical-stage biopharmaceutical company Pharmacyclics Inc. (PCYC) have come a long way since bottoming out in early 2009. Back in February 2010, when we alerted readers to PCYC , it was trading around $4, and there is no denying the great run this stock has had since then. PCYC touched a new intraday high of $11.60 on July 8, 2011 before closing at $11.54.
Let's revisit Pharmacyclics and take a walk through the developments in the company's pipeline...
Pharmacyclics is focused on developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. There are four product candidates in clinical development and several preclinical molecules under testing.
The company's lead clinical candidate is PCI-32765, an inhibitor of Bruton's tyrosine kinase (Btk). PCI-32765, which is under phase II development, is being evaluated for various indications including, chronic lymphocytic leukemia, mantle cell lymphoma and diffuse large B-cell lymphoma.
In light of the compelling efficacy and safety demonstrated by PCI-32765 to date, there has been speculation about a partnership for the drug candidate since a while now, which has piqued the interest of investors.
As the company continues to make progress in its PCI-32765 phase II program this year, it will analyze data from the trials on an ongoing basis.
- The initial 3-month data from chronic lymphocytic leukemia / small cell lymphocytic lymphoma trial testing PCI-32765 is expected to be available in the second half of this year. The company plans to initiate a phase III study in CLL/ SLL in the first half of 2012.
- Enrollment in a phase II study, testing PCI-32765 in mantle cell lymphoma, is expected to be completed by the end of this year. Interim results are expected to be presented at the 2011 American Society of Hematology Meeting to be held in December. A phase III study is anticipated to be initiated in 2012.
- In May, the company began enrollment in a multicenter, open-label, phase II study of PCI-32765 in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL. Enrollment is expected to be completed in the first quarter of calendar 2012.
- A separate pilot study of PCI-32765 in patients with ABC subtype DLBCL is currently being conducted at the NIH Clinical Center. Thus far, 8 out of a planned 10 patients have been enrolled. Though too early to report full results of the pilot study, according to the company, objective responses, including complete responses, have been observed. The results are expected to be submitted for presentation at the 2011 American Society of Hematology Meeting.
PCI-27483, an inhibitor of clotting factor VIIa, is also a mid-stage drug candidate that is being tested in patients with locally advanced or metastatic pancreatic cancer. The phase II study of PCI-27483 is currently enrolling patients.
Pharmacyclics' other two candidates in clinical development include, PCI-24781 an inhibitor of histone deacetylase that is currently in multiple clinical trials, and Motexafin Gadolinium (MGd, PCI-0120), a radiation and chemotherapy sensitizing agent for brain cancer.
PCI-24781 is undergoing a phase I trial in patients with advanced solid tumors, a phase I/II trial in sarcoma patients and a phase I/II trial in patients with relapsed or refractory NHL. The company is also enrolling patients in a phase II study of PCI-24781 in patients with follicular lymphoma. The phase II data in the follicular lymphoma trial is expected by the end of this year. Pharmacyclics inked a global strategic alliance with French pharmaceutical company Les Laboratoires Servier in April 2009 to research, develop and commercialize PCI-24781.
Motexafin Gadolinium is currently under a single arm phase I/II multi-center study in newly diagnosed patients with glioblastoma multiform (a type of primary brain cancer).
And now, a quick look at the company's balance sheet...
Pharmacyclics has incurred significant operating losses since its inception in 1991. As of March 31, 2011, the company had an accumulated deficit of roughly $402 million, cash of $54.4 million and zero debt. The company has not generated any commercial revenues from the sale of its products, and the revenue that is being reported is associated with its collaboration and license agreement with Servier. Pharmacyclics raised $57.1 million in a registered direct offering last month.
As the lead PCI-32765 program continues to make progress, PCYC is well worth watching.
To read the 2010 alert, please click here
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