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Old 04-08-2010, 01:46 PM   #1
Joe
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Do It Yourself Herceptin Treatment

I came across the following information:

Halozyme Announces Roche Doses First Patient In Phase 3 Clinical Trial With Subcutaneous Herceptin.
22 Oct 2009

Halozyme Therapeutics, Inc. (Nasdaq:HALO) and Roche announced dosing of the first patient in a Phase 3 registration trial using Enhanzeâ„¢ technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation with Roche's anticancer biologic, Herceptin (trastuzumab). This represents the first Roche product to enter a Phase 3 registration study as part of the Halozyme Roche collaboration and initiation of the clinical trial has triggered a milestone payment of $5 million to Halozyme. Herceptin is approved to treat HER2-positive breast cancer and currently is given intravenously (IV).

This innovative technology is anticipated to allow patients with HER2-positive breast cancer to administer Herceptin themselves with or without the support of a healthcare professional via a simple subcutaneous injection. Infusion-free administration with subcutaneous Herceptin means for example that patients with early breast cancer completing their one year of Herceptin therapy would have greater convenience of being able to receive treatment at their family doctor's office or at home without having to go to a hospital, a significant and welcome benefit.

"The start of this Phase 3 subcutaneous Herceptin trial is a major achievement for the Halozyme and Roche collaboration, representing the first Roche target to reach a pivotal trial. It reflects years of focus, dedication, and teamwork with the aim of providing an innovative solution for improved patient
care," said Jonathan Lim, M.D., Halozyme's President and CEO. "I congratulate the alliance on the speed of progress to Phase 3."
In addition, offering Herceptin treatment outside of the hospital setting could reduce costs and potentially help to maximize the efficient use of hospital resources.

Subcutaneous Herceptin would come in a ready-to-use administration device instead of an infusion-bag that needs to be prepared by a pharmacist. Physicians and nurses would conduct fewer infusions at the hospital freeing up infusion chair time for other procedures. Additional information about this Phase 3 subcutaneous Herceptin clinical trial can be found at
http://www.clinicaltrials.gov and http://www.roche-trials.com.

Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme,
rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional eight potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche biologics directed at
multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.


Regards
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Old 04-08-2010, 03:07 PM   #2
StephN
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Re: Do It Yourself Herceptin Treatment

Thanks, Joe -

I have been watching this company for about a year - maybe I got wind of it at AACR last year?

Anyway the stock is an attractive price! Just hope they can get more approvals on what they are working on.
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MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 04-08-2010, 04:29 PM   #3
Rich66
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Re: Do It Yourself Herceptin Treatment

"offering Herceptin treatment outside of the hospital setting could reduce costs and potentially help to maximize the efficient use of hospital resources."

Yeah! Now make it oral like Tykerb. Then combine them: Hercepkerb.
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Old 04-15-2010, 07:16 PM   #4
hutchibk
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Re: Do It Yourself Herceptin Treatment

Tyceptin. Except, medicare likes to make it difficult to get oral meds paid for...
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NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)

Nov'03~ dX stage 2B
Dec'03~
Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~
Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~
micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~
micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg

Apr'07~
MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~
Started Tykerb/Xeloda, no WBR for now
June'07~
MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~
MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~
PET/CT & MRI show NED
Apr'08~
scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~
MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~
dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~
Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~
new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~
new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~
25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.

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Old 04-15-2010, 09:30 PM   #5
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Re: Do It Yourself Herceptin Treatment

Brenda,

You crack me up!

Reminded me of the combining forms of the word tyronosaurus... Think the Medicare people will be frightened at the whisper of 'he who shall not be named' and soften their stand?
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Old 04-16-2010, 11:34 AM   #6
ElaineM
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Wink Re: Do It Yourself Herceptin Treatment

A Herceptin shot sounds pretty cool to me !! However, a Herceptin pill might might also go well with Tykerb pills.
People would not have to show up in the chemo room as often making everything more convenient and giving people more free time for other things.
Of course getting insurance companies on board might involve a whole new ball game.
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