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Tuesday, 10/19/2010 4:37:48 PM

Tuesday, October 19, 2010 4:37:48 PM

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PR 10-18-10: Peregrine Reports Positive Ph.2 Cotara Data (MOS=86wks vs. SOC/ Temodar=24wks, n=14 at lead site)… Reposted after adding Roth & LifeTech analysts comments from the Reuters/Beasley update article, MLV comments from AANI’s post, and another Cotara vs. SOC/Temodar MOS-wks comparison at the bottom…

”Peregrine Reports Promising Interim Survival Data From Phase II Cotara(R) Brain Cancer Study
• Single Medical Center Reports Interim Median Overall Survival of 86 Weeks in Patients With Glioblastoma Multiforme (GBM) Treated at First Relapse
• Data Presented at 2010 Congress of Neurological Surgeons Annual Meeting
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=519513

TUSTIN & SAN FRANCISCO, Oct. 18, 2010: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today reported interim data from an ongoing Phase II clinical trial of its novel brain cancer therapy Cotara(R). Interim median overall survival was 86 weeks for a cohort of 14 patients with glioblastoma multiforme (GBM) treated at first relapse with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue.

"Interim survival data from patients treated with Cotara have been encouraging, previously ranging from 38 to 41 weeks, when expected survival for these patients is typically 24 weeks from time of disease recurrence," said Joseph S. Shan, M.P.H., vice president, clinical and regulatory affairs of Peregrine Pharmaceuticals. "We look forward to completing enrollment of the few remaining patients in this Phase II trial before the end of this year and reporting data by mid-year next year. Once this trial is completed and we have analyzed the data, we plan to meet with the FDA to determine the optimal registration pathway for Cotara."

As part of an ongoing Phase II clinical trial of 40 patients with GBM at first relapse, 15 GBM patients (mean age 48.5 years) were enrolled at the All India Institute of Medical Sciences (AIIMS) in New Delhi, India, the lead clinical site. Interim data available for 14 of these patients showed median overall survival of 86 weeks and follow-up duration ranges from between 4 and 107 weeks. Cotara has been granted orphan drug status and Fast Track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. Food and Drug Administration (FDA).

"Overall median survival of 86 weeks far exceeded our expectations in this very difficult to treat patient population where treatment options are few and rarely extend median survival beyond 6 months," said Deepak Gupta, M.D., assistant professor of neurosurgery at AIIMS. "Interim data indicate that Cotara appears well-tolerated and active in GBM patients studied. We believe Cotara represents a promising experimental therapy for patients with this most deadly form of brain cancer."

These new interim data are being presented in a poster at the 2010 Congress of Neurological Surgeons (CNS) Annual Meeting in San Francisco, California. The CNS is a world leader in neurosurgical education and innovation with over 7,000 members worldwide. For more information, please visit http://w3.cns.org/meetings/2010/index.asp .

ABOUT PEREGRINE'S PHASE II COTARA TRIAL
Peregrine's ongoing Phase II open-label trial is enrolling up to 40 GBM patients at first relapse at sites in the U.S. and India. The primary endpoint is safety and tolerability of the maximum tolerated dose, a single 25-hour interstitial infusion of 2.5 mCi/cc of Cotara. Secondary endpoints include overall survival, progression free survival, and proportion of patients alive at six months after treatments. For additional information, please visit http://clinicaltrials.gov/ct2/show/NCT00677716?term=cotara&rank=1.

ABOUT COTARA
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor site in the brain.

ABOUT BRAIN CANCER
According to the American Cancer Society, in 2010 there will be an estimated 22,000 malignant tumors diagnosed and approximately 13,000 deaths attributed to brain or spinal cord cancer in the United States. The most common type of brain cancer is glioblastoma multiforme (GBM), which accounts for 60% of all malignant brain cancers. An aggressive form of cancer, GBM is the deadliest form of brain cancer, with a five-year survival rate of only 3%. Currently approved therapies include Temodar (temozolomide) [ 2-4-10: Temodar has annual global sales of ~$1 billion http://tinyurl.com/2evj6d4 ] and Avastin (bevacizumab), both of which have modest effect on patient survival.

ABOUT ALL-INDIA INSTITUTE OF MEDICAL SCIENCES
One of the most prestigious medical colleges in India, All-India Institute of Medical Sciences (AIIMS) was established as an institution of national importance by an act of the Indian Parliament. With comprehensive facilities for teaching, research, and patient care, AIIMS' objective is to provide a high standard of medical education and training in India.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara(R). Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
CONTACT: Amy Figueroa, Peregrine Pharmaceuticals, 800-987-8256, info@peregrineinc.com

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OCT16-21 2010: “CONGRESS OF NEUROLOGICAL SURGEONS ANNUAL MEETING”, SANFRAN
http://w3.cns.org/meetings/2010/index.asp
Oct18, 3:00-4:30pmPT, Poster: "Glioblastomas: Recent Developments and Lessons Learned from Collateral Targeting Agent Therapy in Recurrent High grade Gliomas: A Single Center Experience"
Deepak Gupta, M.D., assistant professor of neurosurgery at the All India Institute of Medical Sciences (AIIMS) in New Delhi, India [Peregrine’s Phase II Cotara/GBM trial's lead clinical site]
http://w3.cns.org/meetings/2010/attendees/prelim.asp

= = = = = = = = = =
10-18-10: D.Gupta, CNS’10 Abstract (Ph.2 Cotara/GBM, Interim n=14):
Overall median survival of 86 weeks far exceeded our expectations in this very difficult to treat patient population where treatment options are few and rarely extend median survival beyond 6 months."
http://www.cns.org/guide/findAuthorsDetails.aspx?lname=41628

VS.

8-29-05: “In a prior Phase 2 study, a subset analysis of recurrent GBM patients who received a therapeutic dose of Cotara between 1.25 & 2.5 mCi/cc of tumor volume demonstrated a 58% improvement in median survival (38 weeks versus 24 weeks) compared to patients treated with temozolomide, which is the current standard of care for GBM.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=7533714

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10-18-10 REUTERS FOLLOWUP ARTICLE (Update1):
10-18-10: “Peregrine: Brain Cancer Trial Results Show Promise”
* Median survival 86 weeks vs expected 24 weeks
* Full results from Phase II trial expected mid-2011
* Shares rise 18% (Adds share price, Analyst comments)
By Deena Beasley, Reuters
http://www.reuters.com/article/idUSN1827371520101018

LOS ANGELES, Oct 18, 2010 (Reuters): Interim results from a mid-stage trial of an experimental brain cancer drug developed by Peregrine Pharmaceuticals Inc (PPHM) show that patients lived about 3 1/2 times as long as would be expected if they were left untreated [note: “left untreated” should read “treated with curr. std-of-care (SOC) drug Temodar at first relapse”], according to the company.

The promising data sent Peregrine shares up nearly 27%.

Peregrine said the trial's first 14 patients lived a median of 86 weeks, compared with expected survival of about 24 weeks for patients whose cancer has recurred. "It's extremely encouraging," Joseph Shan, the company's head of clinical and regulatory affairs, told Reuters in a telephone interview. Shan said a couple of patients treated in an earlier trial of the drug, Cotara, are still alive 9 years later.

The current trial is expected to enroll up to 40 patients with glioblastoma multiforme -- the most common and deadly form of brain cancer -- whose disease has recurred following standard treatment. The initial findings are from patients enrolled at a medical center in New Delhi, India. Full trial results, including U.S. sites, are expected by mid-2011.

"The interim data from the lead clinical site looked very strong for the 14 patients," said Stephen Dunn, an analyst for Lifetech Capital [ http://LifeTechCapital.com ]. "This is in patients who had their first relapse, so they had already failed another treatment. Median survival of 86 weeks, that's pretty impressive," Dunn said.

Cotara is a genetically engineered antibody designed to target certain cancer cells that also carries a cell-killing radioactive isotope. It is infused directly into the tumor, with the aim of sparing healthy tissue from the radiation. Peregrine said it plans to meet with U.S. regulators next year to discuss how best to move forward with development of the drug.

"Physicians know how long these patients are expected to survive on average and that's why these data are very, very promising," said Joseph Pantginis, an analyst for Roth Capital Partners [ http://www.roth.com ]. Because there is a huge unmet medical need for new treatments for this type of brain cancer, Pantginis said, Peregrine may seek an accelerated approval that could avoid lengthy Phase III clinical trials. "The data are certainly positive, but they still need to define what the potential approval path will be."

Similar "radioimmunotherapies" like Zevalin, now sold by Spectrum Pharmaceuticals Inc (SPPI) for non-Hodgkin's lymphoma, have had limited commercial success due largely to a combination of reimbursement issues and the complexity of coordinating patient care between oncologists and hospitals.

Steven King, Peregrine's CEO, said Zevalin, which is infused throughout the body, is associated with bone marrow suppression -- which is not an issue with Cotara since it is sent directly into brain tumors. He explained that a radiation/oncology group is involved in delivering the drug, but patients are being overseen by a neurosurgeon. "Clearly we think there is a nice market for a drug like Cotara," King said. "It is only used as single agent, single infusion, but there is the potential to combine it with other drugs." Side effects of Cotara seen in the trial included swelling of the brain, seizures and headaches. The study results were presented at the Congress of Neurological Surgeons Annual Meeting in San Francisco.

Peregrine shares were up 30 cents, or 18.3%, at $1.94 on Nasdaq after climbing as high as $2.08 earlier in the day.
*end*

AND THIS 10-18-10 UPDATE FROM ANALYST GEORGE B. ZAVOICO OF MLV:
(extracted from AANI-Bull’s iHub post #57493)
McNicoll, Lewis, Vlak (NYC) http://www.mlvco.com
PPHM (Nasdaq), Recommendation: BUY, Target Price: $10.00
George B. Zavoico, PhD, Senior Equity Analyst
10-18-10: ”Median Overall Survival of 86 Weeks Seen in Brain Cancer Patients Treated with Cotara”
Current Price (10:15am) $1.90, MktCap=$106.76mm, SharesOS=56.19mm
This morning, before markets opened, Peregrine announced the interim results of a Phase II trial of its radioimmunotherapeutic, Cotara, in patients with relapsed glioblastoma multiforme (GBM), an aggressive form of brain cancer, from a single center in India. The median overall survival (OS) in a cohort of 15 patients was 602 days (86 weeks)… This open label Phase II study is enrolling patients with recurrent GBM at 1st relapse. Cotara is administered over a 25 hour period by a microinfusion pump via 2 stereotactically implanted intratumoral catheters. 6 treatment-related adverse events and 3 serious adverse events unrelated to study drug were noted in 4 patients (brain edema, headache, and seizures that resolved over a 4-week period). Target enrollment for this trial is 40 patients. In 15 patients, mean (not median) progression free survival (PFS) and mean OS was 385 ± 80.5 days (55 weeks) and 420 ± 77.5 (60 weeks) days, respectively, with follow-up ranging from 29 to 743 days (as noted above, median OS was 86 weeks). The investigators conclude that treatment of recurrent GBM with Cotara is safe, feasible, and efficacious in prolonging survival. We caution investors that these results are from a single center (7 centers in the U.S. and India are participating in this trial). Nevertheless, in our view the median OS is a considerable improvement compared to prior experience with other types of treatment. MLV is maintaining its BUY recommendation and one year price target of $10.00 for Peregrine Pharmaceuticals, Inc.
VALUATION
Based on our long-term revenue and expense projections, we think Peregrine could become profitable in 2014 (FYE April 30) with continued growth of its contract manufacturing sales revenue (we project a 16% annual growth rate) and approval and launch of bavituximab for the treatment of treatment naive and refractory NSCLC in combination with existing chemotherapeutic agents and of Cotara for the treatment of GBM. We caution investors that approval of bavituximab and Cotara by the FDA and their commercialization depends on favorable clinical trial outcomes. We use a discounted P/E model applied to our projected 2015 EPS to arrive at our current value of $6.50 per share and 1-year price target of $10.00 per share… MLV is maintaining its BUY recommendation and one-year price target of $10.00 for Peregrine Pharmaceuticals, Inc.

= = = = = = = = = = = = =
ORIG. CNS’10 ABSTRACT FOR: Gupta, Deepak
Title: “Glioblastomas: Recent Developments and Lessons Learned from Collateral Targeting Agent Therapy in Recurrent High grade Gliomas: A Single Center Experience” [n=11]
Category: Tumor, Final #1717
INTRODUCTION: Targeted therapies in recurrent glioblastoma multiforme (GBM) appear promising. We report long-term experience and safety/feasibility/efficacy of using intratumoral collateral targeting agent to treat patients with recurrent glioblastoma
METHODS: Eleven cases (recurrent GBM) received targeted therapy agent (2.5 mCi/cc baseline Clinical target volume CTV) using NIH developed microinfusion pump through two stereotactically implanted intratumoral catheters over 25 hours. CTV was noted (baseline) and 8 weekly neurological/ MRI/laboratory examination done to assess tumor response/progression. Spatial drug distribution was noted using PET scan and Gamma camera one week postop. Safety was evaluated on the basis of incidence of procedure related, neurological, and systemic adverse events.
RESULTS: The mean age group (50.1±14.4yrs) and median Karnofsky score was 90. Average baseline CTV was 30.6±16.6cm3, 42-128mCi received by tumor tissue (60±31.2(range: 25.2-120.6milli Curies) (62-87% of administered radioactivity, mean 78%). Six patients died of tumor progression (mean progression free survival [PFS] and mean overall survival (mOS) after receiving Cotara therapy was 22 and 27 weeks respectively. Among 5 survivors (follow-up: 12wks-80wks), mean PFS is 34 weeks. Till last follow-up, median overall survival after treatment of first recurrence with Cotara therapy is 284 days [41 wks]. Six adverse events (treatment/drug related) noted in 3 patients included brain edema (14.28%), headache (28.57%).
CONCLUSIONS: Intratumoral radio immunotherapy using Cotara compound is safe, feasible and efficacious in prolonging survival in recurrent glioblastoma multiforme cases. The results of experience with this agent will be compared with existing therapies in recurrent glioblastomas.
http://www.cns.org/guide/findAuthorsDetails.aspx?lname=41628

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INDIA (EXPANDED JAN'10 TO U.S.) COTARA/BRAIN PH.2 TRIAL (40 PATIENTS, 1ST RELAPSE):
Protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
…10-18-10: Interim Ph.2 update (n=14) at CNS’10: http://tinyurl.com/349kvca
...PI Dr. Deepak Gupta, "MOS of 86 weeks far exceeded our expectations in this very difficult to treat patient pop. where treatment options are few and rarely extend med.survival beyond 6mos."
…Roth’s Joe Pantginis: “Physicians know how long these patients are expected to survive on avg. and that's why these data are very, very promising. Because there is a huge unmet medical need for new treatments for this type of brain cancer, Peregrine may seek an Accelerated Approval that could avoid lengthy Phase III clinical trials.”

...6-3-10/ASCO: Cotara/Ph.2 Trial 75% enrolled; 3 more U.S. sites added: http://tinyurl.com/33z8ggo
...1-28-10 U.S. site (Barrow/Phoenix) added formerly India-Only Ph.2 trial: http://tinyurl.com/yk565jy
…Per 3-11-10 QtlyCC, VP/ClinAffairs J.Shan said also exp. UPenn & Univ. of S.Car. http://tinyurl.com/yl4befh
…9-2-09 Interim Ph.2 data (10 pts) presented at AANS Annual Mtg/Boston: http://tinyurl.com/mxzbzm
……P.I. Dr. A.K. Mahapatra: “Most importantly, Cotara has demonstrated promising signs of efficacy.”
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99

9-13-10, CEO S.King, R&R/NYC: http://tinyurl.com/23fagxw


= = = = = = = =
10-10-07, Slides showing correlation between Cotara dosage levels and MST vs. Temodar (curr. SOC for GBM): http://tinyurl.com/26s265
CEO Steve King’s 10-10-07 Talk at BioInvForum’07/SanFran
SLIDE 11: Cotara Lessons Learned
Phase II GBM Patients Treated After Multiple Recurrences
Dosing Level Correlated With MST
TotalDose/cc of CTV . . . MTTP(wks) . . . MST(wks)
1.0 mCi . . . . . 8 . . . . . 19
1.5 mCi . . . . . 8 . . . . . 14
2.0 mCi . . . . . 21 . . . . . 56
2.5 mCi . . . . . 20 . . . . . 82+
3.0 mCi . . . . . 13 . . . . . 13
Temozolomide* . . . 9 . . . 24 (Annals of Oncology 2001) - aka “Temodar”



*2-4-10: Temodar now has annual global sales of ~$1 billion - http://tinyurl.com/2evj6d4
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